Menstrual Collection Devices and Applicators

Abstract

In one aspect, the present disclosure relates to a menstrual collection device as described herein. In another aspect, the present disclosure relates to an applicator that aids in positioning the menstrual collection device within a patient. The present disclosure further relates to a system that includes at least one applicator and one or more menstrual collection devices that may be preloaded into the applicator.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 239,460, filed September 1, 2021, the entire disclosure of which is incorporated herein by reference in its entirety. [Technical field]

[0002] The present disclosure relates to products for menstruating users, including menstrual discs and applicators. [Background technology]

[0003] Current solutions available in the menstrual market either involve short-lasting absorption technologies found in tampons and pads, or consist of inconvenient products to place inside the vagina to collect menstrual secretions in menstrual cups and menstrual discs.

[0004] The highly absorbent design of cotton-based products may encourage bacterial growth and (1) the risk of developing toxic shock syndrome (TSS). The popularity of menstrual cups and menstrual discs has been limited due to their inconvenient use. Factors that prevent such widespread use of these menstrual products include, but are not limited to, (2) messy contact during insertion and removal, (3) difficulty in proper positioning, (4) difficulty in removal, and (5) leakage during use.

[0005] Cotton-based products such as pads and tampons use their absorbency to capture menstrual secretions and prevent them from leaking. A drawback of these products is that the user's bleeding is often heavy enough that the product can no longer absorb the menstrual secretions, resulting in leakage. The highly porous material of these products is a vector that promotes bacterial growth and therefore increases the risk of developing toxic shock syndrome.

[0006] Menstrual cups do not absorb menstrual secretions, but rather retain and collect them within the vaginal canal. The cup is designed to open the inside of the vagina and create a suction seal with the vaginal walls to hold it in place. Menstrual cups are typically inserted without the use of an applicator, meaning that the user manually places the cup into their vaginal canal and opens it. Similarly, during removal, the user must manually open the seal on the product in order to withdraw the product from the vaginal canal. While the products are often made of silicone and do not utilize absorption, the task of manually inserting and removing the cup itself is often viewed as an uncomfortable, difficult, and tedious task for users.

[0007] Menstrual discs are disc-shaped devices that are placed in the fornix and under the cervix to collect menstrual secretions. Menstrual discs often require manual insertion and removal by the user, which presents difficulties due to the disc's deeper placement within the body.

[0008] Thus, there remains a need for products that improve menstruators' daily activities during their menstrual cycle. Summary of the Invention

[0009] The present disclosure helps address this need and others, by providing 1) a menstrual collection device suitable for efficiently collecting menstrual secretions to assist a menstruator in the daily activities of their menstrual cycle, 2) an applicator for positioning the menstrual collection device, and 3) a system that encompasses one or more of these products.

[0010] In one aspect, the present disclosure provides menstrual collection devices, which may be referred to in the present disclosure as menstrual discs, which may be reusable in some embodiments or disposable in other embodiments.

[0011] The menstrual collection device may comprise a collection bag having a rim, the collection bag being formed by walls enclosing a chamber having a volume for collecting menstrual discharge, the collection bag having a length between a bottom and a front surface, the collection bag having an opening located at the front surface of the collection bag, the rim circumscribing the opening and having a volume for collecting menstrual discharge, and a pull string or tab attached to the rim or to the wall below the rim.

[0012] In some embodiments the rim comprises: a) the rim is adjustable and the adjustable rim includes an expandable / contractable feature; b) the rim is a co-molded raised material to form a spring, has indentations on both sides, is a molded spiral with variable wall thickness, is a molded spring coil with variable wall thickness, comprises a "C" spring, and / or has any other suitable folding feature; c) the rim is substantially circular, elliptical, or of any other suitable shape; d) the rim is manufactured by a process including injection molding, co-molding, and / or compression molding; and / or e) the rim is concave; The present invention may be further defined by one or more of the following features:

[0013] In some embodiments, a menstrual collection device according to the present disclosure may further comprise a return wall disposed over a portion of the menstrual collection device opening, the return wall being attached to the rim and / or wall of the menstrual collection device. If a return wall is present, in some preferred embodiments the return wall is: a) the return wall slopes downwards as it transitions into the opening; b) The opening is located in the center or on the side of the rim; c) the opening is circular, hexagonal, teardrop, slit, "x" or any other shape suitable for collection of menstrual discharge within the collection bag; d) the function of the return wall is to retain collected vaginal or menstrual secretions from leaking out; and / or e) the opening can be closed or sealed by different mechanisms, including folding, sealing and / or covering the return wall to facilitate disposal; The present invention is further defined by one or more of the following features:

[0014] In some preferred embodiments of the menstrual collection device according to the present disclosure, the collection bag comprises: a) some or all portions of the collection bag have different wall thicknesses to prevent accidental spillage during user activity; b) the collection bag is contoured to prevent spillage; and / or c) the collection bag is in the shape of a hemisphere, a spherical ellipsoid, a truncated cone, or a hemisphere flattened near the base; The present invention may be further defined by one or more of the following features:

[0015] Some preferred embodiments of menstrual collection devices according to the present disclosure include those in which the pull string or pull tab comprises: a) a pull string connects to the menstrual collection device above or below the rim, facilitating removal for the user; b) A pull string or pull tab is connected to the return wall; c) the pull string or pull tab may have a texture for a user's grip; and / or d) the pull string or pull tab is wider and tapered at its point of attachment to the menstrual collection device; The present invention is further defined by one or more of the following features:

[0016] In another aspect, the present disclosure provides an applicator, which may be reusable in some embodiments or disposable in other embodiments, sized and shaped for placement of a menstrual collection device according to the present disclosure. The applicator may be comprised of a barrel and a plunger, the plunger is insertable into the barrel, the barrel is sized to house the menstrual collection device in a folded configuration, and to insert the menstrual collection device under the cervix by pressing the plunger.

[0017] Preferably, the applicator comprises: a) The barrel may be straight, curved or angled; b) the plunger is sized and shaped to mirror the shape of the barrel and to push the menstrual collection device out of the applicator barrel and into the fornix; c) the applicator has a click mechanism having a ring or flange / fingers that protrudes inside the barrel and a portion of the outer surface of the plunger that has one or more notches; d) the barrel includes two or more petal flaps at its distal end; e) the barrel includes one or more grooves or ridges on the wall of the barrel for at least a portion of the length of the barrel, the grooves or ridges being disposed opposite or substantially opposite one another; f) the barrel is formed from a different material than the plunger; g) the petal flaps are formed of a softer, more flexible material than the remainder of the barrel body; h) the plunger is hollow; i) at its proximal end, the plunger terminates in a stopper; and / or j) the plunger includes one or more ridges located on an outer surface of the plunger for at least a portion of the plunger length, the one or more ridges extending from the outer surface of the plunger; The present invention may be further defined by one or more of the following features:

[0018] In yet another aspect, the present disclosure relates to a system or kit including at least one applicator according to the present disclosure and one or more menstrual collection devices according to the present disclosure.

[0019] In yet an additional aspect, the present disclosure relates to a method for manufacturing a menstrual collection device, applicator, or system according to the present disclosure, which may include one or more of injection molding, co-molding, thermal bonding / sealing / crimping, radio frequency sealing, ultrasonic / thermal impulse / radio frequency welding, dip molding, thermoforming, vacuum forming, compression molding, and / or cutting.

[0020] In yet another aspect, the present disclosure provides a method for collecting menstrual discharge, the method comprising: - folding and inserting a menstrual collection device into an applicator barrel of an applicator; -inserting a plunger into a barrel; -inserting an applicator having a menstrual collection device disposed therein into a user's vagina; - pressing the plunger of the applicator to release the menstrual collection device and ensure its correct positioning under the cervix; - Removing the applicator; collecting menstrual discharge with a menstrual collection device; - pulling the pull string or pull tab of the menstrual collection device to remove the menstrual collection device from the vagina; The present invention relates to a method comprising the steps of:

[0021] In a further aspect, the present disclosure relates to the use of products according to the present disclosure and methods of personal care during the menstrual cycle. [Brief description of the drawings]

[0022] [Figure 1A] FIG. 1 is a front view of one embodiment of a menstrual collection device according to the present disclosure.

[0023] [Figure 1B] FIG. 1B is a side view of the embodiment of FIG. 1A.

[0024] [Figure 2A] FIG. 1 is a front view of an embodiment of a menstrual collection device according to the present disclosure.

[0025] [Figure 2B] FIG. 2B is a side view of the embodiment of FIG. 2A.

[0026] [Figure 3A] FIG. 1 is a front view of an embodiment of a menstrual collection device according to the present disclosure.

[0027] [Figure 3B] FIG. 3B is a side view of the embodiment of FIG. 3A.

[0028] [Figure 3C] FIG. 3B is a close-up of the rim of FIG. 3A, showing one possible mechanism for achieving a self-sizing fit.

[0029] [Figure 4A] FIG. 1 is a front view of an embodiment of a menstrual collection device according to the present disclosure.

[0030] [Figure 4B] FIG. 4B is a side view of the embodiment of FIG. 4A.

[0031] [Figure 5A] FIG. 1 is a front view of an embodiment of a menstrual collection device according to the present disclosure.

[0032] [Figure 5B] FIG. 5B is a side view of the embodiment of FIG. 5A.

[0033] [Figure 6A] FIG. 1 is a front view of one embodiment of a system according to the present disclosure showing a menstrual collection device according to the present disclosure disposed within an applicator according to the present disclosure.

[0034] [Figure 6B] FIG. 6B is a side view of the embodiment of FIG. 6A.

[0035] [Figure 6C] FIG. 6B shows the menstrual collection device being released from the applicator of FIG. 6A.

[0036] [Figure 6D] FIG. 6D is a side view of the embodiment shown in FIG. 6C.

[0037] [Figure 7] FIG. 1 is a front view of an embodiment of a menstrual collection device according to the present disclosure.

[0038] [Figure 8A] 1 is a side view of an embodiment of a menstrual collection device according to the present disclosure.

[0039] [Figure 8B] FIG. 8B is a front view of the embodiment of FIG. 8A.

[0040] [Figure 9A] 1 is a side view of an embodiment of a menstrual collection device according to the present disclosure.

[0041] [Figure 9B] FIG. 9B is a front view of the embodiment of FIG. 9A.

[0042] [Figure 10] FIG. 1 is a front view of an embodiment of a menstrual collection device according to the present disclosure.

[0043] [Figure 11] FIG. 1 is a front view of an embodiment of a menstrual collection device according to the present disclosure.

[0044] [Figure 12A] 1 is a side view of an embodiment of a menstrual collection device according to the present disclosure.

[0045] [Figure 12B] FIG. 12B is a front view of the embodiment of FIG. 12A.

[0046] [Figure 12C] 12C is a cross-sectional view of the menstrual collection device shown in FIG. 12B taken along axis 12C-12C.

[0047] [Figure 13A] FIG. 1 illustrates one embodiment of an applicator according to the present disclosure, including a plunger and a barrel.

[0048] [Figure 13B] 13B is a cross-sectional view taken along the longitudinal axis of the applicator of FIG. 13A with the plunger of FIG. 13A assembled to the barrel of FIG. 13A.

[0049] [Figure 13C] 13B is a cross-sectional view along the longitudinal axis of the applicator of FIG. 13A with the plunger fully inserted into the barrel.

[0050] [Figure 14A] FIG. 13B is a cross-sectional view along the longitudinal axis of the applicator of FIG. 13A showing a portion of the plunger and a portion of the barrel, with an enlarged view of the clicking mechanism within the barrel.

[0051] [Figure 14B] FIG. 13 is a perspective view of another embodiment of a barrel.

[0052] [Figure 14C] FIG. 13 shows the inside of the barrel from its proximal end, showing the ring that assists the click mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] Detailed Description In one aspect, the present disclosure provides menstrual collection devices, particularly menstrual discs. Some embodiments include reusable menstrual discs, while other embodiments include disposable menstrual discs.

[0054] In another aspect, the present disclosure relates to an applicator that can be used to place a menstrual disc according to the present disclosure within a user's body. In some embodiments, the applicator may be disposable. In other embodiments, the applicator may be reusable.

[0055] In yet another aspect, the present disclosure relates to a system or kit including one or more menstrual collection devices according to the present disclosure and at least one applicator according to the present disclosure. The system or kit may include disposable menstrual collection devices and applicators and / or reusable menstrual collection devices and applicators. Some systems or kits may include at least one component of the system or kit that is reusable, e.g., the applicator, while the other component, e.g., the menstrual collection device, is disposable.

[0056] Various embodiments of menstrual collection devices will now be described in more detail with reference to Figures 1A, 1B, 2A, 2B, 3A, 3B, 3C, 4A, 4B, 5A, 5B, 7, 8A, 8B, 9A, 9B, 10, 11, and 12A, 12B, and 12C. In some embodiments, a menstrual collection device (generally 10, 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000) according to the present disclosure may have a flexible collection bag (12 or 1010) formed by walls (14, 214, 324, 414, or 1014) surrounding a chamber (16) that may be bowl-shaped when holding a volume of liquid to collect at least menstrual discharge, the chamber (16) having a height (16L or 1014L) between a bottom surface (16B or 1014B) and a front surface (16F or 1014F), and the chamber having an opening (18, 918, or 1018) located at the front surface (16F or 1014F) of the collection bag (12 or 1010). The purpose of the collection bag (12 or 1010) is to collect and contain menstrual discharge.

[0057] In this disclosure, "face side" means the surface where the opening (18, 918, or 1018) to the collection bag (chamber) is located. In this disclosure, "bottom side" is the surface opposite the face side. The collection bag (12 or 1010) has a volume between the front side (16F or 1014F) and the bottom side (16B or 1014B) for collecting menstrual discharge.

[0058] In this disclosure, an "inner surface", e.g., the inner surface of a collection bag, barrel, or plunger, means the surface of a wall that is on the inside of a chamber, collection bag, barrel, or plunger. An "outer surface", e.g., the outer surface of a collection bag, barrel, or plunger, is the outer surface of the wall opposite the inner surface.

[0059] In the present disclosure, the same elements, such as element (21), may be included in different embodiments, and in these different embodiments, the same elements, such as element (21), are preferably indicated by the same reference numerals.

[0060] In this disclosure, the collection bag (12 or 1010) may be referred to as a chamber or bowl. In some embodiments, the collection bag (12) may be foldable and / or expandable to facilitate insertion, particularly placement by an applicator. When unfolded to hold a certain amount of liquid, at least in some embodiments, the collection bag (12 or 1010) may be a bowl or reservoir, which in some embodiments has a substantially curved wall (14 or 1014) and can accommodate a certain amount of menstrual discharge. The collection bag (12 or 1010) has a bottom surface (16B or 1014B), which may be at least partially flat (214, 324), a front surface (16F or 1014F), and a height (16L or 1014L) between the bottom surface (12B or 1014B) and the front surface (12F or 1014F).

[0061] The collection bag (12 or 1010) acts as a reservoir for collecting menstrual discharge. Preferably, the collection bag (12 or 1010) is capable of holding at least 20 ml, 30 ml, or more preferably at least 40 ml of liquid. The collection bag (12 or 1010) may be formed of an elastic or semi-elastic material molded into a bowl-like structure.

[0062] Suitable dimensions for the collection bag (12 or 1010) include, but are not limited to, a height (16L or 1010L) ranging from about 10mm to about 40mm, more preferably from about 15mm to about 35mm, and / or a front diameter ranging from about 55mm to about 75mm, more preferably from about 60mm to about 70mm.

[0063] Some or all portions of the collection bag (12 or 1010) may or may not have different wall thicknesses (14, 214, 324, 414, or 1014) to prevent sudden spillage during user activity. The collection bag may or may not be contoured to prevent spillage. The collection bag may or may not be in the shape of a hemisphere, a spherical ellipsoid that may or may not be tapered towards the pull string (21), a truncated cone, a hemisphere flattened near the bottom, and any other suitable shape. This collection bag may or may not be heat staked to an adjustable rim, may be molded as a single injection part, etc.

[0064] In some embodiments, for example, as shown in wall embodiment (14) or (1014), the wall may be substantially the same thickness from its bottom (16B or 1014B) to its front (16F or 1014F). However, in other embodiments, for example, as shown in embodiment (214), the wall may have a variable wall thickness to improve the wall's ability to expand and contract as needed during use. Additionally, in another embodiment, as shown in wall (324), the wall may include ridges to improve the ability of the collection bag to fit within the user's body.

[0065] The menstrual collection device comprises a rim (20 or 1012). At its front face (16F or 1014F), the wall (14 or 1014F) is connected to the rim (20 or 1012) located around the periphery of the front face (16F or 1014F) of the collection bag (12 or 1010) and is attached to the wall (14, 214, 324, 414 or 1014) of the collection bag (12 or 1010), for example by heat staking or by being co-molded thereto. In some embodiments, the rim (20 or 1012) and the collection bag (12 or 1010) may be manufactured together as one piece. This may be particularly preferred for embodiments in which the menstrual collection device is reusable.

[0066] In other embodiments, preferably those having a disposable menstrual collection device, the rim (20 or 1012) and collection bag (12 or 1010) may be manufactured separately, and the rim (20 or 1012) is then attached to or near the face (14F or 1014F) of the wall (14 or 1014) of the collection bag (12 or 1010).

[0067] One function of the rim (20 or 1012) is to ensure a better fit to prevent leakage during use of the device (10, 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000). Another function of the rim is to collect and contain menstrual discharge. The rim (20 or 1012) may be circular, oval, or any other suitable shape.

[0068] In some embodiments, the rim (20 or 1012) may incorporate an expandable / contractable feature to provide an adjustable fit during use.

[0069] The rim (20 or 1012) of the menstrual collection device of the present disclosure may incorporate a spring / coil or expandable feature that self-sizes the rim to the contours of the user's body upon insertion, providing a flexible range of rim sizes for a personalized, comfortable fit. Self-sizing features the rim having the ability to maintain its most expanded state or shrink to a smaller size based on the user's vault size.

[0070] Some embodiments of the adjustable rim include, but are not limited to, a rim (20) that is co-molded with raised material to form a spring (23), a rim (20) with indentations on both sides (123), a spiral molded rim (20) with variable wall thickness (223, 214), a rim (20) with an inner groove (326) and an outer groove (323), a rim (20) with a spring coil molded with variable wall thickness (a combination of features 223 and 23), a rim (20) with a co-molded "C" spring (423), and / or any other suitable folding feature, etc. The adjustable rim may be round, oval, or any other suitable shape. The manufacturing method may or may not include injection molding, co-molding, compression molding, etc. The adjustable embodiment of the rim (20 or 1012) is suitable for all user's bodies because the adjustable rim can contract or expand as needed.

[0071] In some other embodiments, the rim (20 or 1012) may not include a separate expandable / contractable feature, such as a spring and / or a recess. In some embodiments, the rim (1012), one embodiment of which is shown in Figures 12A-12C, may be concave through its thickness (labeled T in Figure 12C) or may be at least partially concave or semi-concave at its outer edge opposite the edge where the rim (1012) is connected to the wall (1014) of the collection bag (1010). This feature improves the fit within the user's body.

[0072] The rim (20 or 1012) may be circular or substantially circular and self-sizing, with the ability to remain expanded or shrink to a smaller size based on the user's vault size, providing a comfortable fit and minimizing leakage. In some embodiments, the rim (20 or 1012) can have a diameter (labeled D in FIG. 12B) ranging from about 55 mm to about 75 mm, more preferably from 60 mm to about 70 mm.

[0073] The walls of the rim (20 or 1012) can be formed with any thickness (T), for example, ranging from about 2 mm to about 7 mm. The walls may be concave or semi-concave. The height (1012L) of the rim may be adjusted as needed, for example, from about 10 mm to about 20 mm. The rim (20 or 1012) has an outer surface (shown at 1012E in FIG. 12B) and an inner surface (shown at 1012I in FIG. 12B). Some embodiments of the rim (20 or 1012) may incorporate a spring or coil, while other embodiments do not include a spring and / or coil. To improve sealing and prevent leakage, the rim (20 or 1012) may be shaped to promote the self-sizing function of the rim (20 or 1012). For example, the rim (20 or 1012) may be thicker at its edge than at its center and / or the circumference of the rim center may be smaller than the circumference of at least one of the two edges, resulting in a concave or substantially concave shape, one embodiment of which is shown in FIG. 12C.

[0074] In some embodiments, a menstrual collection apparatus according to the present disclosure may include a return wall (22, 122, 222, 322, 422, 522, 622, 722, 822, or 922). In other embodiments, the menstrual collection apparatus does not include a return wall, for example as shown in the embodiment (1000) of Figures 12A-12C.

[0075] If present, the return wall (22, 122, 222, 322, 422, 522, 622, 722, 822, or 922) may be disposed over at least a portion of the front surface of a menstrual collection apparatus according to the present disclosure. The return wall (22, 122, 222, 322, 422, 522, 622, 722, 822, or 922) may be attached to the rim (20) and / or the wall (14, 214, 324, or 414). The return wall helps to retain collected vaginal secretions or menstrual secretions collected within the device to avoid spillage during user activity. The return wall (22, 122, 222, 322, 422, 522, 622, 722, 822, or 922) may or may not slope downward to transition to an opening (18 or 918) that may or may not be in the center or on the side of the rim (20). The opening (18 or 918) may or may not take a circular shape, a hexagonal shape, a teardrop shape, a slit shape, an "x" shape, and any other suitable shape. The function of the return wall is to retain collected vaginal or menstrual secretions from leaking out during user activity. In some preferred embodiments, the return wall (122) may be concave or substantially concave, curling inwards towards the collection bag (12).

[0076] In some embodiments, as shown in FIG. 7, the return wall (522) can include at least one Ziplock® raised feature (523) and at least one Ziplock recess (524) disposed on an exterior surface of the return wall (522), the Ziplock raised feature (523) and the Ziplock recess (524) being spaced apart from one another such that the opening (18) is disposed between the Ziplock raised feature (523) and the Ziplock recess (524), and the Ziplock recess (524) is The ziplock raised feature (523) has a depth and width such that it fits snugly into the recess (524), and the ziplock raised feature (523) and the ziplock recess (524) are spatially aligned with each other such that when the return wall (522) is folded with its outer surface inside the fold, the ziplock raised feature (523) is at least partially aligned with the ziplock recess (524) and can fit into the recess (524) and ziplock the menstrual collection device. This feature can aid in convenient disposal of the disposable menstrual collection device.

[0077] In some embodiments, as shown in FIG. 8, the return wall (622) can include at least one fold lock tab (623) attached to or near a free edge of the return wall (622). The free edge is the edge of the return wall (622) that surrounds the opening (18). Preferably, the tab (623) is located on an inner surface of the return wall (622). The return wall (622) also includes at least one fold lock (624), which can be located on the return wall (622) or on the rim (20) or on the wall (14). The fold lock tab (623) and the fold lock (624) are spaced apart from each other such that the opening (18) is located between them. The fold lock tab (623) and the fold lock (624) are spatially aligned with one another such that when the return wall (622) is folded with its outer surface inside the fold, the fold lock tab (623) can be at least partially aligned with the fold lock tab (624) and the tab (623) fits into the lock (624) to lock the menstrual collection device. This feature can be useful after the disposable menstrual collection device has been disposed of and contains a quantity of liquid.

[0078] Alternatively, and in some embodiments, as shown in Figures 9A and 9B, to aid in disposal of a menstrual collection device containing a volume of liquid (menstrual discharge), the rim (20) or return wall (722) may incorporate a string lock (723) that, when a user pulls on the string (21), collapses the menstrual collection device (700) by closing the outer edge of the return wall (722) towards the opening (18), as shown in Figure 9A. This feature may be useful after the disposable menstrual collection device has been disposed of and contains a volume of liquid.

[0079] In some embodiments, as shown in Figure 10, the return wall (822) can include one or more button raised features (823) and one or more complementary button lock recesses (824) disposed on an exterior surface of the return wall (822). The button raised features (823) and the button recesses (824) are spaced apart from one another such that the opening (18) is disposed between the button raised features (823) and the button lock recesses (824). The button lock recesses (824) have a depth and width such that the button raised features (823) can fit snugly into the recesses (824). The button raised feature (823) and the button lock recess (824) are spatially aligned with each other on the surface of the return wall (822) such that when the return wall (822) is folded with its outer surface inside the fold, the button raised feature (823) can be at least partially aligned with the button lock recess (824) and fit into the recess (824) to lock the menstrual collection device. This feature can aid in convenient disposal of a disposable menstrual collection device containing a certain amount of liquid.

[0080] In some embodiments, as shown in Figure 11, the menstrual collection device (900) may include a removable lid (923) sized and shaped to close the opening (918) in the return wall (922). This feature may aid in convenient disposal of a disposable menstrual collection device containing a volume of liquid. The user removes the device (900) from the body and closes the device (900) by placing the lid (923) over the opening (918).

[0081] In some embodiments, menstrual collection devices according to the present disclosure may include a pull string (21), which in some embodiments may be replaced by a pull tab (not shown). In some other embodiments (not shown), menstrual collection devices according to the present disclosure do not include a pull tab or pull string.

[0082] If present, a pull string (21) or pull tab may be attached to the rim (20 or 1012) and / or to the wall (14 or 1014) below the rim (20 or 1012). The pull string or pull tab connects to the menstrual collection device above or below the rim and serves to facilitate ease of removal by the user. The pull string may or may not have texture for user gripping.

[0083] The pull string (21) or a pull tab in lieu of the pull string (21) is formed of a flexible material and, in use, a portion of the pull string or pull tab may extend from the user's body and is of a length that allows the user to remove the menstrual collection device by pulling the pull string (21) or pull tab. In some embodiments, the length (L) of the pull string (21) or pull tab may range from about 45 mm to about 75 mm, preferably from about 55 mm to about 70 mm.

[0084] The pull tab is preferably wider than the pull string (21), e.g., having a width (W) of about 10 mm to about 25 mm, and flatter than the pull string, e.g., having a thickness of about 0.1 mm or 0.5 mm, to help prevent skin irritation.

[0085] After collection is complete, a pull string (21) or pull tab can aid in removal of the device from below the cervix towards the opening of the vaginal canal.

[0086] One of the technical advantages of menstrual collection devices according to the present disclosure is that they can be positioned by the user and correctly positioned by an applicator. In another aspect, the present disclosure relates to an applicator, some embodiments of which are shown in Figures 13A, 13B, 13C, 14A, 14B, 14C, 6A, 6B, 6C, and 6D. In some embodiments, the applicator may generally include (2000) (Figures 13A to 14C) or (3010) (Figures 6A to 6D), or may consist of a plunger (2012 or 3014) insertable into a barrel (2010 or 3012).

[0087] In some preferred embodiments, the applicator (2000) can consist of a hollow applicator barrel, which may simply be referred to as the barrel (2010 or 3012), and a plunger (2012 or 3014) that can be inserted into the barrel (2010 or 3012). The barrel (2010 or 3012) can be straight, curved, or angled. An embodiment of a straight barrel (2010) is shown in FIG. 13B. An embodiment of a curved or angled barrel (3012) is shown in FIG. 6B. Preferably, the curvature is at the distal portion, away from the front face of the barrel (3012). The distal portion is the portion that is inserted first in use. The front face is the surface that is aligned with the front face of the menstrual collection device in use.

[0088] The plunger (2012 or 3014) is designed to push the collector (10, 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000) out of the barrel (2010 or 3012). The plunger (2012 or 3014) may be curved or not depending on the shape of the barrel. Preferably, if the barrel (3012) is curved, the plunger (3014) is curved to reflect the curvature of the barrel and improve the fit of the plunger (3014) to the barrel (3012). In some preferred embodiments, referring to Figures 13A to 14C, the barrel (2010) has a proximal end (2010P), a distal end (2010D), and a length between the distal end (2010D) and the proximal end (2010P). The barrel (2010) is hollow and encloses a hollow channel (bore) with an opening at the distal end (2010D) and an opening at the proximal end (2010P). As shown in FIG. 14B, the barrel (2010) may have one or more grooves (2015) or ridges (not shown) on the walls of the barrel that serve for a better user grip on the barrel (2010) and for properly orienting the menstrual collection device inside the barrel (2010) and inserting the menstrual collection device. This is due to the menstrual collection device having a pronounced opening / front and bottom surface. The grooves (2015) or ridges (not shown) can extend anywhere from the distal end of the barrel (2010) to the petal flap (2011). In some preferred embodiments, the grooves (2015) or ridges may be located on both sides of the barrel and terminate partway through the barrel (2010).

[0089] The plunger (2012), having a distal end (2012D) and a proximal end (2012P) and a length between the distal end (2012D) and the proximal end (2012P), is sized and shaped to be insertable into a hollow channel of the barrel (2010) through an opening in the proximal end (2010P) of the barrel (2010), for example, as shown in FIG. 13B. The plunger (2010) is further sized and shaped such that the plunger (2012) is fitted to move within the hollow channel of the barrel (2010) along the longitudinal axis 2010P / 2010D of the barrel (2010). In at least some embodiments, the plunger (2010) can be hollow.

[0090] The distal end (2012D) of the plunger (2012) may be tapered, as shown in FIG. 13B, and / or the plunger may include one or more prongs at its distal end.

[0091] The plunger (2012) can terminate at its proximal end (2012P) in a stopper (2013) that can rest on a wall of the proximal end (2010P) of the barrel (2010) after the plunger (2012) has been fully inserted into the barrel (2010), for example as shown in Figure 13C. The stopper (2013) prevents the plunger (2012) from sliding completely into the barrel (2010).

[0092] In use, the plunger (2012 or 3014) can push a menstrual collection device according to the present disclosure, for example (3016) of Figures 6A to 6D, out of the distal end (2010D or 3012D) of the applicator barrel (2010 or 3012), for example as shown in Figure 6C, and further push the menstrual collection device (3016) into the fornix.

[0093] The barrel (2010) may have several petal flaps (2011) at its distal end (2010D). For example, three, four or more petal flaps (2011) as shown in FIG. 14B. A petal flap (2011) is a flap that has one edge attached to or near the distal end (2010D) of the barrel (2010). The opposite edge of the petal flap (2011) remains free and is unattached. Each petal flap (2011) is slightly curved toward the central longitudinal axis of the barrel (2010), and the free edge of the petal flap (2011) may be tapered. When in the closed position, the petal flap (2011) covers the distal opening (2010D) of the barrel (2010), as shown in FIG. 14B. For example, when compressed, such as when the menstrual collection device is released from the distal end (2010D) of the barrel (2010), the petal flaps (2011) can assume an open position in which the free edges of the petal flaps (2011) move away from each other, opening a path for exit from the barrel (2010).

[0094] One function of the petal flaps (2011) is to protect the user's tissue during insertion of the applicator (2000). Another function of the petal flaps (2011) is to protect the menstrual collection device, e.g., (1000), from premature deployment before the applicator has been fully deployed by the user. During deployment of the menstrual collection device (10, 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000), the plunger (2012) can push the menstrual collection device out of the barrel (2010). This barrel-penetrating action opens the petal flaps (2011) away from the central axis of the barrel (2010), releasing, deploying, and positioning the menstrual collection device beneath the cervix.

[0095] The barrel and / or plunger according to the present disclosure may be formed from mixed materials, for example the plunger may be formed from one blend of plastic materials while the barrel may be formed from another blend of plastic materials, and / or the body of the barrel may be formed from one blend of plastic materials while the petal flaps are formed from a different blend of a more flexible and bendable plastic material to allow easy opening of the petal flaps during ejection of the menstrual collection device from the applicator (2000).

[0096] In some embodiments, the overall length of the barrel (2010) from the distal end (2010D) to the proximal end (2010P) of the barrel (2010) may range from about 60 mm to about 120 mm, more preferably from about 90 mm to about 100 mm. The length of the plunger (2012) correlates to the length of the barrel (2010). Preferably, when the plunger (2012) is fully inserted into the barrel (2010), the distal end (2012D) of the plunger (2012) may be aligned with the distal end (2010D) of the barrel (2010).

[0097] The length and width of the plunger (2012) may vary, but is sized such that the plunger (2012) can be pushed through the barrel (2010), as shown in Figures 13B and 13C. The diameter of at least a portion of the plunger (2012) that is insertable into the barrel (2010) is smaller than the diameter of the hollow channel in the barrel (2010). In some embodiments, the length of the plunger (2012) may be from about 80 mm to about 140 mm, more preferably from about 100 mm to about 120 mm.

[0098] In some embodiments, the plunger (2012) can include one or more ridges (2014) located on an outer surface of the plunger (2012) over at least a portion of the plunger length, the one or more ridges (2014) extending from the outer surface of the plunger (2012). The one or more ridges (2014) function to reduce friction between the plunger (2012) and the barrel (2010) as the plunger (2012) is pushed through a hollow channel in the barrel (2010), one embodiment of which is shown in FIG. 13B.

[0099] 14C, in some embodiments, a barrel (2010) according to the present disclosure can include a click mechanism that can include one or more rings (2020) that protrude into the inside of the barrel (2010) near its proximal end (2010P). The rings (2020) are attached to the inside surface of the barrel (2010). The purpose of the click mechanism is to regulate and / or monitor the movement of the plunger (2012) within the barrel (2010). In particular, the click mechanism can prevent the plunger (2012) from separating from the barrel (2010) after the menstrual collection device is deployed and the user withdraws the applicator (2000).

[0100] 14A, in embodiments in which the applicator (2000) includes a click mechanism, the plunger (2012) may further include one or more notches (2022) on its outer surface over at least a portion of its length. The purpose of the one or more notches (2022), if present, in cooperation with the ring (2020), or alternatively with a flange / fingers in place of the ring (2020), is to aid in the functioning of the click mechanism and prevent separation of the plunger (2012) from the barrel (2010) during withdrawal of the applicator (2000) after the menstrual collection device has been placed.

[0101] In use, the menstrual collection device (10, 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000) can be folded and inserted into the applicator (2000 or 3010).

[0102] Thus, in yet another aspect, the present disclosure relates to a system or kit including one or more menstrual collection devices according to the present disclosure and one or more applicators according to the present disclosure, one embodiment, generally (2000), is shown in Figures 6A to 6D.

[0103] In some embodiments, the menstrual collection device may be pre-loaded and folded into the barrel of the applicator, one embodiment of which is shown in FIG. 6A, which shows the menstrual collection device (3016) positioned within the barrel (3012) of the applicator (3010). The use of the applicator supports / ensures accurate positioning of the menstrual collection device (3016) below the cervix. The applicator (2000 or 3010) lowers the steep learning curve in menstrual collection machines, e.g., menstrual cups and menstrual discs, which require tedious manual folding and insertion of the device. The system / kit may comprise one or more menstrual collection devices and at least one applicator. The system / kit may further include at least one user manual.

[0104] The menstrual collection device and applicator of the present disclosure provide important technical advantages and improvements over conventional menstrual cups, which sit within the vaginal canal. In contrast, the menstrual collection device of the present disclosure sits in the fornix just below the cervix, which can provide better leakage protection.

[0105] A system comprising one or more menstrual collection devices according to the present disclosure and at least one applicator according to the present disclosure provides at least the following technical advantages: First, the applicator allows for easy insertion of the menstrual collection device without mess from manual handling and properly positions the menstrual collection device. Second, the menstrual collection device is long-lasting, preferably up to 12 hours. Third, the menstrual collection device is comfortable. Fourth, it can be easily removed using a pull string or pull tab.

[0106] Toxic Shock Syndrome. The menstrual collection device according to the present disclosure is collective and has no absorptive features, greatly reducing the risk of TSS.

[0107] Awkward contact during insertion and removal. The applicator allows the user to avoid using their fingers to insert the product. Furthermore, the pull string or pull tab of the collection device allows for easy removal without using the user's own fingers for positioning and removal of the product.

[0108] Difficult to Properly Position: The applicator allows the user to push the plunger out of the vagina for proper positioning in the fornix, solving the difficult manual positioning that users currently must undergo, where the user inserts their finger into the vagina for proper positioning.

[0109] Difficulty of Removal: The pull string or pull tab attached to the menstrual collection device allows the user to quickly and easily remove the product from the body with a simple tug of the pull string or pull tab.

[0110] The menstrual collection device and applicator according to the present disclosure eliminates the difficult insertion and removal process of menstrual cups and menstrual discs. The applicator minimizes the challenges faced in insertion, while the pull string or tab of the menstrual collection device allows for easy and quick removal. Additionally, the return wall of the menstrual collection device, if present, helps to retain menstrual secretions during and after use.

[0111] Methods of manufacturing products according to the present disclosure may include injection molding, co-molding, heat bonding / sealing / crimping, radio frequency sealing, ultrasonic / heat impulse / radio frequency welding, dip molding, thermoforming, vacuum forming, compression molding, cutting, and the like. The rim may include expandable / contractible, adjustable features such as co-molded raised material to form a spring, indentations on both sides, a spiral molded with variable wall thickness, a spring coil molded with variable wall thickness, a "C" spring, or any other suitable folding feature. The rim may be round, oval, or any other suitable shape. Manufacturing methods may include injection molding, co-molding, compression molding, and the like. The collection bag may be thermoformed, cut, and / or heat staked to the rim in some embodiments, or may be molded as a single injection molded part, and the like. In some embodiments, the menstrual collection product may be injection molded in its entirety.

[0112] In a further aspect, the present disclosure relates to the use of a menstrual collection device and applicator according to the present disclosure for personal care during the menstrual cycle. In one embodiment of the application method, the method includes one or more of the following steps: folding and inserting the menstrual collection device into an applicator barrel; inserting a plunger into the barrel; inserting the applicator barrel with the folded menstrual collection device into the vagina of a user; pressing the applicator plunger to release the menstrual collection device and ensure its correct positioning under the cervix; removing the applicator; collecting menstrual discharge with the menstrual collection device; and pulling the pull string or pull tab of the menstrual collection device to remove the menstrual collection device from the vagina after use is completed. In further embodiments, the kit may include one or more menstrual collection devices and at least one applicator. In these embodiments, the applicator can be pre-loaded with the folded menstrual collection device before use for simplicity.

Claims

1. 1. A menstrual collection device comprising: a collection bag having a rim, the collection bag being formed by walls enclosing a chamber having a volume for collecting menstrual exudates, the collection bag having a length between a bottom and a front, the collection bag having an opening located at the front of the collection bag, the rim surrounding the opening and having a volume for collecting menstrual exudates; and a pull string or pull tab attached to the rim or to the wall below the rim.

2. The menstrual collection device of claim 1 , wherein the menstrual collection device is reusable or disposable.

3. The rim is a) the rim is adjustable, and the adjustable rim includes an expandable / contractable feature; b) the rim is a co-molded raised material to form a spring, has recesses on both sides, is a spiral molded with variable wall thickness, is a spring coil molded with variable wall thickness, comprises a "C" spring, and / or has any other suitable folding feature; c) the rim is substantially circular, oval, or of any other suitable shape; d) the rim is manufactured by a process comprising injection molding, co-molding, and / or compression molding; and / or e) the rim is concave; 3. The menstrual collection device of claim 1 or 2, further defined by one or more of the following features:

4. 3. The menstrual collection device of claim 1 or 2, further comprising a return wall positioned over a portion of the opening of the menstrual collection device, the return wall being attached to the rim and / or the wall of the menstrual collection device.

5. The return wall is a) the return wall slopes downwards to transition into the opening; b) the opening is located in the center or on the side of the rim; c) the opening is circular, hexagonal, teardrop-shaped, slit-shaped, "x"-shaped, or any other shape suitable for collecting menstrual discharge within the collection bag; d) the function of the return wall is to retain collected vaginal or menstrual secretions from leaking out; and / or e) the opening can be closed or sealed by different mechanisms, including folding, sealing and / or covering the return wall to facilitate disposal; The menstrual collection device of claim 4 further defined by one or more of the following features:

6. The collection bag a) some or all portions of the collection bag have different wall thicknesses to prevent accidental spillage during user activity; b) the collection bag is contoured to prevent spillage; and / or c) the collection bag is in the shape of a hemisphere, a spherical ellipsoid, a truncated cone, or a hemisphere flattened near the base; 3. The menstrual collection device of claim 1 or 2, further defined by one or more of the following features:

7. The pull string or pull tab is a) the pull string connects to the menstrual collection device above or below the rim and serves to facilitate removal for the user; b) the pull string or the pull tab is connected to the return wall; c) the pull string or pull tab may have a texture for grip by the user; and / or d) the pull string or pull tab is wider and tapered at its point of attachment to the menstrual collection device; 3. The menstrual collection device of claim 1 or 2, further defined by one or more of the following features:

8. 10. An applicator comprising a barrel and a plunger, the plunger being insertable into the barrel, the barrel being sized to accommodate the menstrual collection device of claim 1 in a collapsed configuration and to insert the menstrual collection device under the cervix by depressing the plunger.

9. The applicator of claim 8 , wherein the applicator is reusable or disposable.

10. The applicator comprises: a) the barrel is straight, curved, or angled; b) the plunger is sized and shaped to mirror the shape of the barrel, forcing the menstrual collection device of claim 1 or 2 out of the applicator barrel and into the fornix; c) the applicator has a click mechanism having a ring or flange / fingers projecting inwardly from the barrel and a portion of the outer surface of the plunger having one or more notches; d) the barrel includes two or more petal flaps at its distal end; e) the barrel includes one or more grooves or ridges on the wall of the barrel for at least a portion of the length of the barrel, the grooves or ridges being positioned opposite or substantially opposite one another; f) the barrel is formed of a different material than the plunger; g) the petal flaps are formed of a softer, more flexible material than the remainder of the barrel body; h) the plunger is hollow; i) at its proximal end, said plunger terminates in a stopper; and / or j) the plunger includes one or more ridges located on the outer surface of the plunger for at least a portion of the plunger length, the one or more ridges extending from the outer surface of the plunger; The applicator of claim 8 , further defined by one or more of the following features:

11. A system or kit comprising at least one applicator according to claim 8 and one or more menstrual collection devices according to claim 1.

12. 12. A method for manufacturing the menstrual collection device of claim 1, the applicator of claim 8, or the system of claim 11, said method comprising one or more of injection molding, co-molding, thermal bonding / sealing / crimping, radio frequency sealing, ultrasonic / thermal impulse / radio frequency welding, dip molding, thermoforming, vacuum forming, compression molding, and / or cutting.

13. 1. A method for collecting menstrual discharge, said method comprising: - folding the menstrual collection device according to claim 1 or 2 and inserting it into the applicator barrel of the applicator according to claim 8 or 9; - inserting the plunger into the barrel; - inserting the applicator barrel into the user's vagina; - pressing the plunger of the applicator to release the menstrual collection device and ensure its correct positioning under the cervix; - removing the applicator; - collecting menstrual discharge with said menstrual collection device; - pulling the pull string or pull tab of the menstrual collection device to remove the menstrual collection device from the vagina; A method comprising:

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