Patent Description:
There are various types of devices that are currently used in an effort to prevent a flow of fluid (e.g. menses) from soiling a user's clothing. Two of the more common devices used for such a purpose are a tampon and a menstrual cup. A tampon operates on a principle of absorbing bodily fluids, whereas a menstrual cup operates on a principle of collecting bodily fluids.

Tampons have gained wide acceptance in the overall feminine care market based at least in part on the relative ease of disposal following use, the tendency of a tampon to conform to the user's individual anatomy, and the potential ease of insertion via an "applicator" (sometimes referred to as an "inserter" in the art). However, in some instances tampons may have a tendency to dry a user's vaginal wall, and may have a limited effective utilization time period (e.g., depending on the volume of menstrual flow). Prior art menstrual cups, on the other hand, are typically not associated with vaginal wall dryness and generally can be effectively used for longer periods of time relative to a tampon. However, relative to tampons, menstrual cups are typically more difficult to insert, can be messy to remove from the user, and typically do not accommodate an individual user's particular anatomy very well.

Suffice it to say, there are no devices currently available that provide the comfort, familiarity, and ease of insertion and removal of a tampon combined with the extended duration of use and/or fluid retention capacity of a menstrual cup.

<CIT> discloses a menstrual device comprising frame which an interior cavity and an exterior circular rib with at least one gap.

<CIT> and <CIT> each discloses a menstrual device having a frame with an interior cavity and outer bulges or ribs which extend continuously around the frame.

Finally, <CIT> also discloses a menstrual device having a frame with an interior cavity and a conically widening opening.

The invention provides for a menstrual device as defined in claim <NUM>. Individual embodiments of the invention are the subject matter of the dependent claims.

According to an aspect of the present invention, a menstrual device comprises.

In an embodiment of the present invention, the cavity is divided in a single cavity above the step-change and a single cavity below the step-change and wherein the cavity has a ratio of the diameter of the widthwise and/or depthwise dimension at a location immediately above the step-change to the widthwise and/or depthwise dimension at a location immediately below the step-change of between about <NUM>:<NUM> to about <NUM>:<NUM>, or between about <NUM>:<NUM> to about <NUM>:<NUM>, or between about <NUM>:<NUM> to about <NUM>:<NUM>.

In another embodiment of the invention, the step-change also involves a change in the number of cavities with a single cavity above the step-change and cavities below the step-change.

In still another embodiment of the invention, the surface ratio of the cavity at a location immediately above the step-change to the surface area of the cavity or all cavities at a location immediately below the step-change is between about <NUM>:<NUM> and <NUM>:<NUM>, or between <NUM>:<NUM> and <NUM>:<NUM>, or less than or equal to about <NUM>:<NUM>, or greater than or equal to about <NUM>:<NUM>.

In a further embodiment of the invention, the cavity below the step-change comprises four cavities.

In one additional embodiment of the invention, the cavities below the step-change (<NUM>) are at least <NUM> (<NUM> inches) and up to about <NUM> (<NUM> inches).

In a further additional embodiment of the invention, the cavity is divided in a single cavity above the step-change and at least two cavities below the step-change and wherein the surface ratio of the single cavity at a location immediately above the step-change to the surface area of the at least two cavities at a location immediately below the step-change is between about <NUM>:<NUM> and <NUM>:<NUM>, or between about <NUM>:<NUM> and <NUM>:<NUM>, or less than about <NUM>:<NUM>, or greater than or equal to about <NUM>:<NUM>.

The invention will be described in more detail referring to the drawings in which a plurality of embodiments are disclosed with the embodiments of <FIG> being embodiments according to the invention.

Referring to the drawings, according to an aspect of the present disclosure a menstrual device <NUM> is provided that includes a frame <NUM> and at least one removal element <NUM>. The menstrual device <NUM> and frame <NUM> provide for the collection of fluids. "Collecting" or "collection" and other tenses as used throughout the present disclosure, is defined as the ability to collect fluids within the menstrual device <NUM> by either retaining fluids and/or absorbing fluids. The term "absorbing" or "absorbent" and other tenses as used throughout the present disclosure, is defined as a porous material having the ability to hold fluids inside a material's matrix, such that fluid ingratiates the material's structure and/or resides within pores or interstitial voids between the material's structure. The term "retain" or "retention" and other tenses as used throughout the present disclosure, is defined as the ability to hold fluid within the device like, for instance, a cup.

In some embodiments, the menstrual device <NUM> and frame <NUM> provide for the retention of fluids. In some embodiments, the menstrual device <NUM> may also include an absorbent material <NUM> (see <FIG>) and/or an absorbent article <NUM> (see <FIG>).

Referring to <FIG>, <FIG>, embodiments of the present menstrual device <NUM> include a frame <NUM> having at least one side wall <NUM>, a distal end <NUM>, a proximal end <NUM>, an interior cavity <NUM>, and a seal layer <NUM>. The side wall <NUM> has a thickness <NUM> extending between an interior surface <NUM> and an exterior surface <NUM>. The proximal end <NUM> has a proximal end surface <NUM>. In some embodiments (e.g., see <FIG>, <FIG>, 2A, <FIG>), the distal end <NUM> includes an interior surface <NUM> and an exterior surface <NUM>, and a thickness <NUM> that extends there between. The distal end <NUM> of the frame <NUM> is closed; e.g., the interior cavity <NUM> is not accessible through the distal end <NUM> (i.e., is fluid impermeable at the distal end <NUM>). The proximal end <NUM> of the frame <NUM> may be described as being "open" in an expanded configuration (as will be described below) in that the interior cavity <NUM> is accessible through the proximal end <NUM> of the frame <NUM>; e.g., open to allow the collection of menstrual fluids within the interior cavity <NUM>.

To facilitate the description herein, the menstrual device <NUM> will be described herein as having a lengthwise axis <NUM> that extends along an X-axis, a widthwise axis <NUM> that extends along a Y-axis, and a depthwise <NUM> axis that extends along a Z-axis (see <FIG>). As will be described below, the menstrual device <NUM> may assume a variety of different geometric shapes. In each of these shapes, the menstrual device <NUM> (and therefore the frame <NUM>) may assume a plurality of configurations; e.g., a "compact configuration", a "deployed configuration", and an "at rest configuration". The particular geometric shape of a menstrual device is visible when the menstrual device is its' "at rest configuration". To facilitate description of these different menstrual device geometric shapes, as well as the respective configurations of each, the menstrual device <NUM> (and therefore the frame <NUM>) may be described as having a cross-sectional area (i.e., in the Y-Z plane). Depending on the particular geometric shape of the menstrual device <NUM>, in the deployed and at rest configurations, the cross-sectional area of the menstrual device <NUM> may differ at different lengthwise positioned sections (e.g., see sectional views 1B-1B, 1C-1C, 1D-1D, etc.; e.g., a truncated conical shaped device as shown in <FIG>), or the cross-sectional area may be equal at different lengthwise positioned sections (e.g., a tubular shaped device as shown in <FIG>).

A menstrual device <NUM> configured in a "compact configuration" is shown in <FIG>. The term "compact configuration" as used herein refers to a configuration wherein the frame <NUM> of the menstrual device <NUM> is elastically deformed (e.g., by squeezing, compressing, or folding the frame <NUM>) to an extent wherein the interior cavity <NUM> has a volume less than is present in a deployed configuration. "Elastic" as used herein, describes strain a material can recover from, contrasted to strain that causes the material to plastically deform. In some instances when the menstrual device <NUM> is in a compact configuration, the interior cavity <NUM> has a "zero" value cavity volume; e.g., the side wall interior surfaces <NUM> come together with no volume there between, or said differently, the cavity is obfuscated. As will be evident from the description below, in some embodiments the frame <NUM> may be elastically deformed (e.g., compressed) to not only have a zero interior cavity <NUM> volume, but also the frame <NUM> may be elastically deformed further to assume a lesser volume; e.g., a configuration having a zero interior cavity <NUM> volume and compressed side walls. In some instances when the menstrual device <NUM> is in a compact configuration, the interior cavity <NUM> has a volume (e.g., the side wall interior surfaces <NUM> do not completely come together), but that volume is less than the interior cavity <NUM> would have in a deployed configuration. To facilitate the description of the present menstrual device <NUM>, a menstrual device <NUM> in a compact configuration may be described as occupying a first volume.

A menstrual device <NUM> in a "deployed configuration" can be seen in <FIG>. In the deployed configuration, the menstrual device <NUM> is in a partially compressed configuration; i.e., assuming a volume less than the volume of the same device at rest, but more volume than the same device in a compact configuration. <FIG> diagrammatically shows forces acting on the exterior surface <NUM> of the device <NUM> that cause the device to be in a slightly compressed configuration; i.e., a deployed configuration. The term "deployed configuration" refers to a menstrual device <NUM> configuration that may be assumed under normal use conditions; e.g., a configuration that may be typically assumed during use of the device when the device <NUM> is located in its intended functional position. In a deployed configuration, menstrual device <NUM> embodiments that include an interior cavity <NUM>: a) have an interior cavity <NUM> volume greater than zero (e.g., at least some side wall interior surface <NUM> portions are separated from one another to create a greater than zero volume there between); and b) have an interior cavity <NUM> that is open (i.e., accessible) at the proximal end <NUM> of the frame <NUM>. The menstrual device <NUM> in a deployed configuration has less than or equal to one hundred percent (<NUM>%) of the "at rest" configuration's dimensions and/or volume. The menstrual device <NUM> in a deployed configuration can be described as occupying a second volume that is greater than a first volume.

A menstrual device <NUM> in an "at rest" configuration is shown in <FIG>, <FIG>, <FIG>, and <FIG>. The term "at rest" as used herein refers to the configuration a menstrual device <NUM> assumes by itself (i.e., expands to) when no external forces are applied to the menstrual device <NUM>, therefore the device <NUM> is at rest and geometrically stable (e.g., no applied forces acting on the device <NUM> that prevent the frame <NUM> from further expanding). In an at rest configuration, device <NUM> embodiments having an interior cavity <NUM> will have an interior cavity volume greater than zero. In an at rest configuration, the interior cavity <NUM> is open (i.e., accessible) at the proximal end <NUM> of the frame <NUM>. In an at rest configuration the menstrual device can be described as having a third volume that is greater than the first volume, and/or greater than or equal to the second volume.

The frame <NUM> is configured such that in the absence of applied forces holding the frame <NUM> in a compact configuration, the frame <NUM> will by itself elastically change from a compact configuration to a deployed configuration (i.e., where some amount of applied forces are still applied to the device <NUM> that prevent the device <NUM> from completely expanding to an at rest configuration), or will completely elastically expand to an at rest configuration (e.g., the configuration independently assumed in the absence of forces applied to the device <NUM>).

The ability of the frame <NUM> to elastically expand (e.g., from a compact configuration to a deployed configuration or an at rest configuration) does not utilize any liquid (absorbed or otherwise incorporated into the frame <NUM>) as a mechanism of change. In some embodiments, the elastic expansion of the frame <NUM> is accomplished by the frame <NUM> unfolding. In some embodiments, the elastic expansion of the frame <NUM> is a function of the frame material being inherently elastically expandable between a compressed configuration (e.g., a compact configuration) and an expanded configuration (e.g., a deployed configuration or an at rest configuration). In some embodiments, the ability of the frame <NUM> to elastically expand may be a combination of these mechanisms, or other mechanisms.

In some embodiments, the interior cavity <NUM> and therefore the volume of the interior cavity <NUM> is completely defined by the interior surface <NUM> of the side wall <NUM> (e.g., see <FIG>). In those embodiments where the distal end <NUM> of the frame <NUM> includes an interior surface <NUM> and an exterior surface <NUM> (e.g., see <FIG>, <FIG>, <FIG>), the interior cavity <NUM> (and its volume) is defined by the interior surface <NUM> of the side wall <NUM> and the interior surface <NUM> of the distal end <NUM>.

The frame <NUM> comprises one or more materials, which collectively have mechanical material properties that enable the frame <NUM> to: a) be elastically deformed or folded into a compact configuration; and b) in the absence of applied forces holding the frame <NUM> in a compact configuration, self-expand into an expanded configuration; e.g., without utilizing any liquid (absorbed or otherwise incorporated into the frame <NUM>) as a mechanism of change. An example of an acceptable frame material is an elastic polymer that can be formed into a geometric shape useful for a menstrual device <NUM>; e.g., an elastic polymer formed to assume a desired geometric shape and volume in an at rest configuration (i.e., in the absence of applied forces) and which polymer can be elastically compressed to a smaller volume and thereby assume a reduced volume configuration (e.g., a deployed configuration or a compact configuration). Specific non-limiting examples of elastic polymers include medical grade and/or biocompatible polyester, polyvinyl alcohol (PVA), polypropylene, polyacrylate, or polyurethane foams such as aliphatic that resist changes in color and/or aromatic, and/or starch-based foams such as those made from crosslinked polysaccharides. The term "foam" as used herein refers to a substrate construction having internal voids, which voids may vary in size and number per volumetric unit.

The mechanical material properties of the frame material(s) that enable the frame <NUM> to elastically expand from a compact configuration to an expanded configuration may be described in terms of "expansion forces". To illustrate, consider a frame <NUM> maintained in a deployed configuration (e.g., see <FIG>, wherein the menstrual device <NUM> assumes a volume less than the volume of the same device in an at rest configuration). Body wall surfaces <NUM> (e.g., vaginal wall surfaces) in contact with the menstrual device <NUM> to potentially prevent the menstrual device <NUM> from assuming its fully expanded configuration (i.e. the at-rest configuration), and thereby maintain the menstrual device <NUM> in the partially compressed deployed configuration. The vaginal cavity is known to typically exert a pressure between about <NUM> psi (<NUM> x <NUM>-<NUM> bar) and about <NUM> psi (<NUM> x <NUM>-<NUM> bar). As a result, the expansion forces <NUM> that would otherwise cause the menstrual device <NUM> to elastically expand to an at rest configuration, now act against the body wall surfaces <NUM>. Those expansion forces <NUM>, which are quantifiable, are at least a part of the mechanism that enables the menstrual device <NUM> to be maintained at a particular position within the user's vagina. It should be noted from the above that menstrual devices <NUM> according to the present disclosure are intended to assume an expanded configuration, albeit one that is potentially partially compressed configuration (i.e. a deployed configuration), during in vivo use. The expansion forces <NUM> are described as being "at least part of the mechanism" that enables the device to be positionally retained because other factors may also play a part in retaining the device; e.g., the coefficient of friction of the exposed surface of the seal layer <NUM>, the coefficient of friction of the body wall surface <NUM>, the geometric shape of the menstrual device <NUM>, etc. For the present menstrual device embodiments, the frame <NUM> is chosen to have mechanical material properties (as described above) that produce expansion forces adequate to retain the device <NUM> in vivo in a deployed configuration, while at the same time such expansion forces <NUM> are below a magnitude that: a) would cause user discomfort; b) inhibit or prevent the menstrual device <NUM> from being placed in a compact configuration (e.g., for insertion purposes with or without an applicator); and/or c) inhibit removal of the menstrual device <NUM> from an in vivo deployment. The expansion forces <NUM> produced by the frame material are further discussed below in the context of an applicator device that may be used with the present menstrual device <NUM>.

As indicated above, the frame <NUM> (and therefore the menstrual device <NUM>) may assume a variety of different geometric shapes three-dimensionally and/or in profile or cross-section (i.e. cup-like, conical, tubular, funnel-shaped, tapered and/or shaped), all of which shapes include the interior cavity <NUM>. <FIG>, for example, show a frame <NUM> in an enlarged configuration having a truncated conical shape. <FIG> show a frame <NUM> in an enlarged configuration having a tubular shape. <FIG> show a frame <NUM> in an enlarged configuration having a conical shape. In some embodiments as those exemplified in at least <FIG>, the menstrual device has symmetry about its vertical axis (i.e. X axis). <FIG> show a frame <NUM> in an enlarged configuration having a widthwise dimension that is non-linearly variable along the length of the device. The present menstrual device <NUM> is not limited to these particular geometric shapes. In <FIG>, <FIG>, <FIG>, <FIG>, the frame <NUM> is shown as being symmetrical within the Y-Z plane; i.e., the Y and Z dimensions are identical or nearly identical. In alternative embodiments, the present menstrual device <NUM> may have a geometric shape that is non-symmetrical in the Y-Z plane; e.g., the width dimension (i.e., the Y direction) may be greater than the depth dimension (i.e., the Z direction); e.g., an oval shape. In addition, or alternatively, the geometric shape may be non-symmetrical along its length; e.g., cross-sectional Y-Z plane geometries may vary at different lengthwise positions. For example, the geometric shape of the frame <NUM> may be customized for in-vivo placement for enhanced sealing performance; e.g., shaped to have a geometric shape that conforms with a particular shape associated with a vaginal region where the device is intended to be deployed.

As indicated above, menstrual devices <NUM> according to the present disclosure are intended to assume an expanded configuration (e.g., a deployed configuration), albeit one that is potentially partially compressed, during in vivo use; it is possible the menstrual device <NUM> could be fully expanded about a portion or a region, and/or fully expanded, as anatomy of the vaginal canal varies. Nonetheless, based on in vivo testing identifying anatomical features, dimensions, it is likely the menstrual device <NUM> will be partially compressed during in vivo use. The expansion forces associated with the partially compressed menstrual device <NUM> create a seal between the side wall exterior surfaces of the device and the user body wall surfaces <NUM>. The aforesaid seal helps to prevent fluid passage between the side wall exterior surface and the user body wall surface <NUM> during use. In all menstrual device <NUM> embodiments having an interior cavity <NUM>, the geometric shape of the frame <NUM> is such that when the device is deployed in vivo in its operational position, the interior cavity <NUM> of the frame <NUM> is open at the proximal end <NUM> to enable the interior cavity <NUM> to receive and collect menstrual fluids. It is recognized that during use, movement of the user may cause the present menstrual device <NUM> to deflect and potentially assume a variety of different geometric shapes. As such, in some user physical positions it is possible that the present menstrual device <NUM> may be compressed; e.g., into a configuration wherein the interior cavity <NUM> is not open at the proximal end <NUM>. Nevertheless, the statement above regarding the interior cavity <NUM> of the frame <NUM> being open (when deployed in vivo in its operational position) reflects that the interior cavity <NUM> of the frame <NUM> is open at the proximal end <NUM> during most but not necessarily all possible user positions.

The frame <NUM> may be manufactured using a variety of different techniques. An acceptable example of such a technique is polymer molding technique wherein the frame <NUM> is molded to have the desired geometric configuration. Molding is particularly useful when the frame <NUM> is formed from an elastic polymer foam.

The menstrual device <NUM>, in an at rest configuration, has a length along its lengthwise axis of between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>), and more preferably between about <NUM> inches (<NUM>) and <NUM> inches (<NUM>). In some embodiments, the length of the menstrual device is about <NUM> inches (<NUM>), <NUM> inches (<NUM>), or about <NUM> inches (<NUM>). For clarity, the length of the menstrual device <NUM> is from its proximal end <NUM> to its distal end <NUM> defining the fluid collection portion of the device; it does not include any additional length of the removal element <NUM>.

The menstrual device <NUM>, in an at rest configuration, has a proximal end <NUM> width dimension along the widthwise axis of between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>), and more preferable between about <NUM> inches (<NUM>) and <NUM> inches (<NUM>). In some embodiments, the width of the menstrual device at the proximal end is about <NUM> inches (<NUM>), <NUM> inches (<NUM>) or about <NUM> inches (<NUM>).

The menstrual device <NUM>, in an at rest configuration, has a proximal end <NUM> depth dimension along the depthwise axis of between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>), and more preferable between about <NUM> inches (<NUM>) and <NUM> inches (<NUM>). In some embodiments, the depth of the menstrual device at the proximal end is about <NUM> inches (<NUM>), <NUM> inches (<NUM>) or about <NUM> inches (<NUM>).

In some embodiments of the menstrual device <NUM> in an at rest configuration, the ratio between the length and the width at the proximal end <NUM> is greater than <NUM>. In other embodiments, the ratio is between about <NUM> and about <NUM>. In other embodiments, the radio between the length and the width at the proximal end <NUM> is greater than <NUM>. In other embodiments, the ratio is between about <NUM> and about <NUM>.

The menstrual device <NUM>, in an at rest configuration, has a distal end <NUM> that has less than or equal to the widthwise and/or depthwise dimension of the proximal end <NUM>. For instance, the widthwise dimension and/or depthwise dimension at the distal end <NUM> is between about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>). In some embodiments, the ratio of the widthwise dimension and/or depthwise dimension at the proximal end <NUM> to the widthwise dimension and/or depthwise dimension at the distal end <NUM> is between about <NUM>:<NUM> and <NUM>:<NUM>. In some embodiments, this ratio is between about <NUM>:<NUM> and about <NUM>:<NUM>. In other embodiments, this ratio is between about <NUM>:<NUM> and about <NUM>:<NUM>. In further embodiments, this ratio is greater than <NUM>. In yet further embodiments, this ratio is less than <NUM>:<NUM>. In yet other embodiments, this ratio is about <NUM>:<NUM>, about <NUM>:<NUM>, or about <NUM>:<NUM>.

In some embodiments, the menstrual device <NUM>, in an at rest configuration, has a widthwise dimension and depthwise dimension, at any given cross-sectional slice in the Y-Z plane, have a ratio between the widthwise dimension and the depthwise dimension of about <NUM>:<NUM>. Nonetheless, in a deployed configuration, this ratio may change and be between <NUM>:<NUM> and <NUM>:<NUM> depending on the anatomical geometry of a given user. This widthwise/depthwise ratio can be dynamic as the menstrual device <NUM> collects fluid and/or as the user moves through a variety of positions, and/or other changes the body undergoes over time throughout a given period of time when the menstrual device <NUM> is worn (i.e., which can be for several hours).

The cavity <NUM>, in the at-rest configuration, has a length dimension along the lengthwise axis of between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>), or between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>), or between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>). In some embodiments, the cavity <NUM> has a length dimension that is less than half of the length of the menstrual device <NUM>, or said differently, the ratio of the length of the cavity <NUM> to the length of the menstrual device is less than or equal to <NUM>:<NUM>. In some embodiments, this is preferred in order to maintain resiliency in the device sufficient to go from a compact configuration to a deployed configuration such that the deployed configuration is able to exert a pressure against the vaginal wall to create a sufficient seal thereby mitigating leakage, albeit a pressure that is not otherwise uncomfortable or noticeable to the user.

<FIG> demonstrates how the dimensions of the menstrual device <NUM> provide varying expansion profiles. Specifically, <FIG> describes radial pressure (psi, bar) exerted by menstrual device <NUM> as a function of the level of radial compaction of the menstrual device as described in the title (reference numeral <NUM>). The horizontal axis <NUM> describes the diameter of the menstrual device in mm, while the vertical axis <NUM> describes the radial force in psi (bar). Three samples having a frame material including AQUAZONE 4lb foam made by FXI were tested, where the highest curve labeled "<NUM>" regards a menstrual device that is <NUM> inches (<NUM>) in length, with a cavity having a length of <NUM> inches (<NUM>), the middle curve labeled "<NUM>" regards a menstrual device that is <NUM> inches (<NUM>) in length, with a cavity having a length of <NUM> inches (<NUM>), and the lowest curve labeled "<NUM>" regards a menstrual device that is <NUM> inches (<NUM>) in length, with a cavity having a core that is <NUM> inches (<NUM>) in length. If one reads <FIG> from right to left, one notes the diameter in the at-rest configuration of the three samples. Moving towards the vertical axis (i.e., from right to left), one sees each of the three samples undergoing radial compression, and as the compressive force is applied (thereby reducing the diameter of each sample) a force is exerted. The <NUM> inch (<NUM>) sample with the shallowest cavity provided the greatest amount of resistance to compression (or the ability to apply the greatest radial pressure of the samples), while the <NUM> inch (<NUM>) sample with a deeper cavity provided the least amount of resistance (or the ability to apply the lowest radial pressure of the samples). Nonetheless, the data demonstrates the menstrual device <NUM> of the present disclosure provides a radial pressure that assists in creating a seal with the vaginal wall of at least <NUM> psi (<NUM> x <NUM>-<NUM> bar), enough to provide an opposite force of similar magnitude to that of the vaginal wall. In some embodiments, a pressure of at least <NUM> psi (<NUM> x <NUM>-<NUM> bar) is provided, and in further embodiments, a pressure of at least <NUM> psi (<NUM> x <NUM>-<NUM> bar) is provided. In some embodiments, the menstrual device <NUM> of the present disclosure is able to provide a pressure of at least <NUM> psi (<NUM> x <NUM>-<NUM> bar) with a deployed configuration diameter of at least <NUM> (or <NUM>% of its at-rest diameter).

In some embodiments, it is preferred to have a cavity <NUM> having a length dimension that is greater than <NUM> inches (<NUM>) due to the relatively slow fluid penetration times of the frame <NUM> material, as measured by a high speed camera, distilled water, and a goniometer such as Model DSA100 made by Kruss, having a needle providing a <NUM> drop size where the needle tip is positioned a distance of <NUM> from the proximal end <NUM> of the menstrual device <NUM>. For instance, a <NUM>" by <NUM>" cubic sample of AQUAZONE foam material (density of <NUM> pounds) made by FXI has a fluid penetration time that is about four times slower than a regular absorbency tampon branded TAMPAX PEARL made by Procter & Gamble, demonstrating some embodiments of the menstrual device <NUM> of the present disclosure have a frame <NUM> with distinct fluid handling characteristics than that of typical tampon pledgets made of rayon, cotton, or the like. As such, the cavity <NUM> provides a reservoir to retain fluid and increase the exposed surface area of the frame <NUM> while permitting the frame <NUM> to absorb fluid. In some embodiments, the ratio of the exposed surface area provided by the cavity <NUM> versus the surface area of just the proximal end <NUM> (in embodiments without a cavity) is between about <NUM>:<NUM> to about <NUM>:<NUM>, or is greater than <NUM>:<NUM>, or is less than <NUM>:<NUM>, or is about <NUM>:<NUM>.

In some embodiments such as those shown in <FIG>, the cavity <NUM> is a single lengthwise cavity that is generally tubular such that the widthwise and/or depthwise dimension at the proximal end <NUM> is about equal to the widthwise and/or depthwise dimension at the distal end <NUM>. In other embodiments such as those demonstrated in <FIG>, the cavity <NUM> has a taper such that the cavity <NUM> has a greater widthwise and/or depthwise dimension at the proximal end <NUM> than at the distal end <NUM>. The cavity <NUM> has a ratio of the widthwise and/or depthwise dimension at the proximal end <NUM> to the widthwise and/or depthwise dimension at the distal end <NUM> is between about <NUM>:<NUM> and <NUM>:<NUM>. In some embodiments, this ratio is between about <NUM>:<NUM> and about <NUM>:<NUM>. In other embodiments, this ratio is between about <NUM>:<NUM> and about <NUM>:<NUM>. In further embodiments, this ratio is greater than <NUM>. In yet further embodiments, this ratio is less than <NUM>:<NUM>. In yet other embodiments, this ratio is about <NUM>:<NUM>, about <NUM>:<NUM>, or about <NUM>:<NUM>.

In embodiments of the present disclosure as exemplified in <FIG>, the cavity <NUM> has a step-change <NUM> in widthwise and/or depthwise dimension [as one moves along the length of the menstrual device <NUM> from a proximal end <NUM> to the distal end <NUM>]. For exemplary purposes, the step change <NUM> is shown by the change in color (i.e., the lighter grey indicates a location 27A above step-change <NUM>, and the darker grey indicates a location 27B below the step-change <NUM>). The step-change <NUM> in widthwise and/or depthwise dimension describes an abrupt change in such dimension (i.e. not a gradual taper). In some embodiments having a single cavity <NUM> above the step change <NUM> to a single cavity <NUM> below the step change <NUM> (i.e. as exemplified in <FIG> and/or with respect to one of the four cavities 26A, 26B, 26C, and/or 26D in <FIG>), the cavity <NUM> has a ratio of the diameter of the widthwise and/or depthwise dimension at a location 27A immediately above the step change <NUM> of to the widthwise and/or depthwise dimension at a location immediately below 27B the step change <NUM> of between about <NUM>:<NUM> to about <NUM>:<NUM>, or between about <NUM>:<NUM> to about <NUM>:<NUM>, or between about <NUM>:<NUM> to about <NUM>:<NUM>.

In other embodiments, a step-change <NUM> in widthwise and/or depthwise dimension [as one moves along the length of the menstrual device <NUM> from a proximal end <NUM> to the distal end <NUM>] involves a change in the number of cavities. As exemplified in <FIG>, cavity <NUM> becomes four cavities 26A-26D. The number of cavities <NUM> can vary from one to a plurality, keeping in mind typical cavities are at least <NUM> inches (<NUM>) (in a minimum widthwise and/or depthwise dimension if the cavity is not constant along the lengthwise axis) and up to about <NUM> inches (<NUM>) (in a maximum widthwise and/or depthwise dimension if the cavity is not constant along the lengthwise axis) in widthwise and/or depthwise dimension and need to be spaced apart to ensure the cavities do not collapse upon each other. In one embodiment, the ratio of the surface area of the cavity <NUM> immediately above 27A the step-change <NUM> to the surface area of the cavity (or all cavities) <NUM> immediately below 27B the step-change <NUM> is between about <NUM>:<NUM> and <NUM>:<NUM>, or less than or equal to about <NUM>:<NUM>, or greater than or equal to about <NUM>:<NUM>.

In embodiments having a single cavity <NUM> immediately above 27A a step-change <NUM> and at least two cavities (i.e. 26A, 26B) immediately below 27B the step-change <NUM>, the ratio of the surface area of the cavity <NUM> immediately above 27A the step-change <NUM> to the surface area of the cavities (i.e. 26A, 26B) below 27B the step-change <NUM> is between about <NUM>:<NUM> and <NUM>:<NUM>, or between about <NUM>:<NUM> and <NUM>:<NUM>, or less than about <NUM>:<NUM>, or greater than about <NUM>:<NUM>.

Another aspect of the menstrual device <NUM> of the present disclosure is that it is distinct from commercially available internally worn menstrual devices in where fluid collects first. As with commercially available tampon pledgets, fluid is typically absorbed into the pledget at the top region of the pledget (i.e. the proximal end) and travels downward towards the bottom of the pledget. In other words, commercially available pledgets absorb fluid in the top region first, and fluid thereafter travels downward. Commercially available menstrual cups act oppositely. Fluid is retained within the menstrual cup and pools at the bottom and fills upward. The menstrual device of the present disclosure collects fluid differently, in part due to the fact that it collects fluids. In embodiments with cavities, the fluid collects in the middle region of the pledget (i.e. not solely at the proximal surface of a tampon pledget, and not solely by filling from the bottom-up of the menstrual cup). In embodiments where the cavity <NUM> (or cavities <NUM>) have a length that is at least about <NUM>% and up to about <NUM>% of the length of the menstrual device <NUM>, the fluid will initially collect to a middle region. As it collects in the middle region, fluid travels downwardly and outwardly from where the fluid is being directed into the menstrual device <NUM> as the frame <NUM> (absorbent layer <NUM>, and/or absorbent article <NUM>, as discussed below) absorbs fluid. As the frame <NUM> (absorbent layer <NUM>, and/or absorbent article <NUM>, as discussed below) absorbs fluid and meets its gram per gram capacity, the fluid is collected upwardly and outwardly. If the length of the cavity <NUM> (or cavities) exceeds <NUM>% of the length of the menstrual device <NUM>, the fluid will collect from the bottom region upward.

Fluid collection for a menstrual device <NUM> embodiment is exemplified by <FIG>, and is generated by micro-CT scanning using a radiotransparent test fixture applying a <NUM> psi (<NUM> x <NUM>-<NUM> bar) pressure to simulate in-body pressures (note: the test fixture in <FIG> is dark grey, contrasted with menstrual device <NUM> seen as a lighter grey, and the fluid is seen as black, or darker than the text fixture and menstrual device <NUM>). This test apparatus and methodology is described more fully in <CIT> titled "Four-Dimensional Analysis System, Apparatus, and Method" The menstrual device <NUM> is placed within a condom (or other fluid impermeable material/membrane; seen in <FIG> in white surrounding menstrual device <NUM>) with a line transmitting fluid placed directly above the proximal end <NUM> and centered over cavity <NUM> (the tip of the needle on the line is shown as the white moon-shaped feature at the top of each <FIG>). Fluid is pumped at a controlled rate into the menstrual device <NUM> (shown in grey) over time ("t"), as demonstrated by <FIG> at exemplary times t = <NUM> seconds, t = <NUM> seconds, t = <NUM> seconds, and t = <NUM> seconds, respectively. As demonstrated by the figures, the middle region of the menstrual device <NUM> collects fluid, distributing fluid downward towards distal end <NUM>, radially outward, and thereafter collects upward until the entire menstrual device volume is exhausted.

<FIG> demonstrate how commercially available tampon pledgets absorb fluid, in the aforementioned test apparatus with the same set-up, having exemplary times t = <NUM> seconds, t = <NUM> seconds, and t = <NUM> seconds, respectively. As shown, commercially available tampons absorb fluid top-down.

In any embodiment, the compact configuration dimensions are less than the aforementioned dimensions in the at-rest configuration. In any embodiment, the deployed configuration dimensions can be up to or equal to the aforementioned dimensions in the at-rest configuration. As discussed above, these dimensions take into account various parameters including typical length, depth and width of the vaginal canal, pressure exerted by the vaginal canal, collection capacity meeting or exceeding existing internally worn menstrual devices such as cups and tampons, and mitigating against leakage and vaginal irritation such as dryness caused by commercially available rayon/cotton tampon products.

The seal layer <NUM> is disposed on at least a portion of the exterior surface <NUM> of the side wall <NUM>. In those embodiments wherein the frame <NUM> includes a distal end exterior surface <NUM>, the seal layer <NUM> is also disposed on the distal end exterior surface <NUM>.

In some embodiments, the seal layer <NUM> is disposed on only a portion of the exterior surface <NUM> of the side wall <NUM>; i.e., the seal layer <NUM> extends from the distal end <NUM> toward, but not completely to, the proximal end <NUM>; e.g., see <FIG>. In some of these embodiments, the seal layer <NUM> is impermeable and as such, to increase the amount of surface area of the frame <NUM> that can collect fluid (and thus help mitigate against leakage), a portion of the frame <NUM> is not covered by the seal layer <NUM>. In some embodiments, the length of the exterior surface <NUM> of side wall <NUM> that is not covered by the seal layer <NUM> is up to <NUM>% of the total length of the menstrual device <NUM>, or up to <NUM>%, up to <NUM>%, or greater than <NUM>%. In some embodiments, the length of the exterior surface <NUM> of side wall <NUM> that is not covered by the seal layer <NUM> is between about <NUM>% and about <NUM>%.

In some embodiments, the seal layer <NUM> is disposed on the entirety of the exterior surface <NUM> of the side wall <NUM>; i.e., the seal layer <NUM> extends from the distal end <NUM> all the way to the proximal end <NUM>; e.g., see <FIG>, <FIG>. In some embodiments, the seal layer <NUM> is disposed on both the entirety of the exterior surface <NUM> of the side wall <NUM>, and also covers at least a portion of the proximal end surface <NUM>; e.g., see <FIG>, and <FIG>. In embodiments where the seal layer <NUM> is disposed on the proximal end surface <NUM>, the seal layer <NUM> covers up to <NUM>% of the proximal end surface, up to <NUM>%, up to <NUM>%, or up to <NUM>%.

The seal layer <NUM> comprises one or more materials that collectively do not appreciably absorb fluid. In some embodiments, the seal layer <NUM> does not appreciably allow fluid to pass through the seal layer <NUM> and into the frame <NUM>. For these embodiments, the seal layer <NUM> is a continuous, non-perforated layer that prevents the passage of fluid there through. Hence, the seal layer acts as a fluid barrier. As will be described below, in some embodiments the seal layer <NUM> may include perforations that allow a limited amount of fluid transfer across the seal layer <NUM> such that it may be stored, retained and collected in menstrual device <NUM>, but mitigate against fluid travelling across the perforated seal layer and out of the menstrual device <NUM> (i.e. by capillary action). In some embodiments, seal layer <NUM> is hydrophobic.

The seal layer <NUM> may be comprised of a variety of different types of materials and is not therefore limited to any particular type of material provided such material(s) is capable of functioning as a fluid barrier. Examples of acceptable seal layer <NUM> materials include molded or thermoformed polymers, flexible films, hydrophobic nonwoven materials, nylon, silicone, polyacrylate, polyurethane, polypropylene, polyethylene and other inert olephins. Preferably any such material is provided in a form that is medical grade and/or biocompatible. Some exemplary films are those made by Bayer, Vancive or Bemis (i.e. Bemis ST-<NUM>, Bemis ST-<NUM>, Bayer VPT <NUM>). As will be described in more detail below, the seal layer <NUM> functioning as a fluid barrier (in particular those embodiments where the seal layer <NUM> provides a complete fluid barrier) provides several advantages. For example, because the seal layer <NUM> does not permit fluid transfer from a vaginal wall (i.e., the wall the device is in contact with) into the menstrual device <NUM>, the seal layer <NUM> prevents the migration of menstrual fluids or other body fluids away from the vaginal wall. As a result, the menstrual device <NUM> is less apt to be associated with undesirable, potentially irritating, vaginal wall dryness. In this regard, it can be seen that the present menstrual device <NUM> does not function as a tampon typically functions. As another example, the seal layer <NUM> functioning as a fluid barrier also enables the frame <NUM> to collect and retain menstrual fluids; e.g., menstrual fluids collected within the interior cavity <NUM> of the menstrual device <NUM> are retained within the interior cavity <NUM>. In those embodiments wherein the frame <NUM> comprises a foam material, the amount of menstrual fluid that can be collected is a function of the interior cavity volume as well as the porous void volume of the frame material. Current testing indicates that these menstrual device configurations can collect and hold up to four times (4x) the volume of menstrual fluid prior to leakage as compared with the maximum menstrual volume a typical tampon pledget can absorb prior to leakage. In addition, the length of time a typical tampon pledget can be worn is influenced by the volume of fluid it can absorb prior to leakage. The ability of the present menstrual device <NUM> to collect a substantially greater volume of fluid (up to 4X) prior to leakage, significantly increases the duration of time the menstrual device <NUM> can be comfortably worn without leakage.

Experimentation has been done to determine the volume capacity of various embodiments of the present disclosure. Testing has been performed with two different set-ups, using, on the one hand, a syngyna apparatus, and on the other, an Ion Simulator. The sygina apparatus used a <NUM>% saline solution [as required by the FDA] and a flow rate of <NUM>/min, while the Ion Simulator used a synthetic menstrual fluid and a flow rate of <NUM>/min. below chart describes various embodiments demonstrating collection up to about four times a regular tampon (i.e. with an absorbency between <NUM> and <NUM>). The below chart describes the dry weight of the menstrual device versus the amount of fluid (in grams) the menstrual device can collect. Samples with <NUM>" and <NUM>" lengths were tested, having a <NUM>" proximal end diameter. All embodiments tested have a seal layer including a biocompatible film.

As demonstrated above in Table <NUM>, varying the geometry of the menstrual device <NUM> has an effect on the g/g absorbency. The above indicates the menstrual device of the present disclosure has a g/g absorption when using the aforementioned syngyna set-up, exceeding <NUM>/g, or between <NUM>/g and <NUM>/g. Using the aforementioned Ion Simulator methodology, the menstrual device of the present disclosure has a g/g absorption exceeding <NUM>/g, between <NUM>/g/ and <NUM>/g. Also demonstrated above in Table <NUM>, the menstrual device <NUM> has an absorbent capacity of at least <NUM>, or at least <NUM>, or at least <NUM>, as measured by the syngyna apparatus using a <NUM>% saline solution and a flow rate of <NUM>/min.

As exemplified above, by comparing the two different test methodologies and fluids, on can more readily correlate absorbency information based on less viscous fluids (i.e. <NUM>% saline) and more viscous fluids (the synthetic menstrual fluid). The correlation factor of typical syngyna fluid to synthetic menstrual fluid is about <NUM>. This enables correlation between various set-ups and parameters (i.e. in vivo studies and in vitro studies).

The seal layer <NUM> may also improve the ease with which the menstrual device <NUM> is ejected from the applicator <NUM>. Due to the menstrual device <NUM> having an at-rest, expanded configuration, ejecting menstrual device <NUM> from applicator <NUM> can be difficult for the user (i.e. requiring the exertion of a greater amount of force than with known tampons). The seal layer <NUM> is a smooth and/or slippery material such that its coefficient of friction is less than that of the frame <NUM> material. As such, seal layer <NUM>, when applied to frame <NUM>, can, in embodiments including an applicator <NUM>, reduce the ejection force of the menstrual device <NUM> from applicator <NUM> to be less than <NUM> ounces, less than about <NUM> ounces, preferably less than <NUM> ounces and more preferably, less than or equal to about <NUM> ounces.

The seal layer <NUM> may be applied to the exterior surface <NUM> of the side wall <NUM> using a variety of different techniques (e.g., applied as a film, or as a coating applied by a spray process or a dipping process, etc.. ), and the seal layer <NUM> application process is not limited to any particular technique. Seal layer <NUM> materials may be adhered to the frame <NUM> using an adhesive. Seal layer <NUM> materials may alternatively be applied to the exterior surface <NUM> and subsequently subjected to a curing type process (e.g., elevated temperatures, UV light, etc.) that causes the seal layer <NUM> material to bond or otherwise adhere to the exterior surface <NUM>. In those embodiments wherein the seal layer <NUM> material is formed as a film prior to application to the frame <NUM>, the seal layer <NUM> film may be applied using a vacuum forming process. In some embodiments where a film seal layer <NUM> is used, the film seal layer <NUM> may include a plurality of film sublayers. For example, the film seal layer <NUM> may include a first sublayer comprised of a first thermoplastic material having a first melt temperature and a second sublayer comprised of a second thermoplastic material having a second melt temperature, wherein the second melt temperature is lower than the first melt temperature. In this embodiment, the film seal layer <NUM> is applied to the frame <NUM> such that the second sublayer is disposed in contact with the exterior surface <NUM> of the side wall <NUM> and the first sublayer is exposed; i.e., the second sublayer is disposed between the first sublayer and the side wall exterior surface <NUM>. During the film seal layer <NUM> application process, the film seal layer <NUM> is subjected to a temperature at or above the melt temperature of the second sublayer, but below the melt temperature of the first sublayer. As a result, the second sublayer acts to bond the first sublayer to the frame <NUM>.

As indicated above, in some embodiments the seal layer <NUM> as described above may include perforations that allow a limited amount of fluid transfer across the seal layer <NUM>. The collective area of the perforations is substantially smaller than the area of the seal layer <NUM>. Because the collective perforation area is much smaller than the entire seal layer area, the amount of fluid transfer across the seal layer <NUM>, is minimal. Hence, a perforated seal layer <NUM> still predominantly functions as a fluid barrier. To the extent that there is fluid transfer across the seal layer <NUM> via the perforations, it is understood such fluid transfer is likely to be fluid transfer into the menstrual device <NUM>.

In an alternative embodiment of the present disclosure shown in <FIG>, the menstrual device <NUM> includes a body <NUM> defined by at least one side surface <NUM>, a distal end <NUM>, a proximal end <NUM>, and a seal layer <NUM>. The side surface <NUM> extends between the distal end <NUM> and the proximal end <NUM>. The proximal end <NUM> has a proximal end surface <NUM>. In this embodiment, the menstrual device <NUM> does not include an interior cavity. The distal end <NUM> may also have a distal end surface <NUM>, depending on the specific geometry of the menstrual device <NUM>.

Referring to <FIG> and <FIG>, embodiments of the present menstrual device <NUM> include a support element <NUM>. The menstrual device <NUM> exemplified in <FIG>, similar to <FIG>, does not have an interior cavity. As shown in <FIG>, the menstrual device <NUM> includes a body <NUM> defined by at least one side surface <NUM>, a distal end <NUM>, a proximal end <NUM>, and a seal layer <NUM>. The side surface <NUM> extends between the distal end <NUM> and the proximal end <NUM>. The proximal end <NUM> has a proximal end surface <NUM>. In this embodiment, the menstrual device <NUM> does not include an interior cavity.

In some embodiments, the frame <NUM> includes the support element <NUM> and an absorbent element <NUM>. The frame is configured so it can be elastically deformed or folded into a compact configuration and can also be expanded into an expanded configuration, i.e., expanded into a deployed configuration or an at rest configuration.

In some embodiments, the support element <NUM> completely encompasses the absorbent element <NUM>. The distal end <NUM> may also have a distal end surface, depending on the specific geometry of the menstrual device <NUM>.

<FIG> provide embodiments including an alternate collection means, having a support member <NUM>, an absorbent element <NUM> that form a side wall <NUM>, a distal end <NUM>, a proximal end <NUM>, an interior cavity <NUM>, and a seal layer <NUM>. Absorbent element <NUM> includes materials described throughout this application relating to frame <NUM>. Seal layer <NUM> can be close-forming around support element <NUM> and/or absorbent element <NUM>, or can be loose-fitting like a bag, thereby enabling the support element <NUM> and/or absorbent element <NUM> to be freely dynamic (i.e. expand upon fluid collection). For clarity, in embodiments where seal layer <NUM> is elastic such that support element <NUM> and/or absorbent element <NUM> are dynamic.

In some embodiments, the support element <NUM> is configured to elastically self-expand; e.g., if radially compressive forces less than those required to hold the support element <NUM> in a compact configuration are applied to the support element <NUM>, the self-expanding support element <NUM> will radially expand into a deployed configuration, or if no radially compressive forces are applied to the support element <NUM>, the self-expanding support element <NUM> will radially expand into an at rest configuration. In the at rest configuration, the self-expanding element assumes a predetermined geometric shape. The elastically self-expanding support element <NUM> expands without utilizing any liquid (absorbed or otherwise) as a mechanism of change. This type of support element <NUM> may be referred to as having an "elastic memory". In other embodiments, the support element <NUM> does not elastically self-expand, or is incapable by itself of causing the menstrual device to self-expand to a deployed configuration.

The support element <NUM> allows the passage of menstrual fluid through the support element <NUM>, and therefore does not provide a fluid sealing function. For example, the support element <NUM> may be formed, at least in part, from one or more materials arranged as a mesh. In these embodiments, the support element <NUM> is not limited to any particular type of mesh arrangement provided the mesh can be elastically deformed or folded into a compact configuration and can also be expanded into an expanded configuration. Some examples include braided mesh. The support element <NUM> is not, however, limited to being formed as a mesh, or having one or more portions formed as a mesh. For example, the support element <NUM> may be formed in part from a woven material, a perforated material, or a non-porous or solid material, or the like, or combinations thereof.

The support element <NUM> is not limited to any particular type material, however medical grade and/or biocompatible materials are preferred. Non-limiting examples of materials that may be used to form a mesh support element <NUM> include any rigid or semi rigid materials, such as polyolefins (i.e. polypropylene, polyester, and polyethylene), thermoplastic elastomers, nylons, and silicones. In some embodiments, the mesh support element <NUM> is non-absorbent in its own right. In some embodiments, the mesh support element <NUM> assists in retention and storage of fluid within menstrual device <NUM>. In some embodiments, the mesh support element assists in directing fluid into and/or within menstrual device <NUM>.

The absorbent element <NUM> comprises a material operable to absorb menstrual fluids either physically or chemically, or some combination thereof. The absorbent element <NUM> is capable of being elastically deformed or folded into a compact configuration and can also be disposed into an expanded configuration; i.e., disposed in a deployed configuration or an at rest configuration.

In some embodiments, the absorbent element <NUM> is configured to elastically self-expand; e.g., if radially compressive forces less than those required to hold the absorbent element <NUM> in a compact configuration are applied to the absorbent element <NUM>, the self-expanding absorbent element <NUM> will radially expand into a deployed configuration, or if no radially compressive forces are applied to the absorbent element <NUM>, the self-expanding absorbent element <NUM> will radially expand into an at rest configuration. In the at rest configuration, the self-expanding absorbent element <NUM> assumes a predetermined geometric shape. The elastically self-expanding absorbent element <NUM> expands without utilizing any liquid (absorbed or otherwise) as a mechanism of change. This type of absorbent element <NUM> may be referred to as having an "elastic memory". In other embodiments, the absorbent element <NUM> does not elastically self-expand, or is incapable by itself of causing the menstrual device to self-expand to a deployed configuration.

For those embodiments where the absorbent element <NUM> is configured to elastically expand, an acceptable absorbent element material is an elastic polymer that can be formed into a geometric shape useful for a menstrual device <NUM>; e.g., an elastic polymer formed to assume a desired geometric shape and volume in an at rest configuration (i.e., in the absence of applied forces) and which polymer can be elastically compressed to a smaller volume and thereby assume a reduced volume configuration (e.g., a deployed configuration or a compact configuration). Specific non-limiting examples of elastic polymers include medical grade and/or biocompatible polyester, polypropylene, or polyurethane foams. The term "foam" as used herein refers to a substrate construction having internal voids, which voids may vary in size and number per volumetric unit.

For those embodiments where the absorbent element <NUM> does not elastically self-expand, acceptable absorbent element materials include, but are not limited to, wood pulp, rayon, cotton, natural or synthetic nonwoven materials, super-absorbent materials (e.g., fibers, films, particles), nanocellulose materials, foams, or any combination thereof. The absorbent material(s) <NUM> is preferably medical grade and/or biocompatible.

As indicated above, embodiments of the present menstrual device <NUM> include a frame <NUM> having at least one side wall <NUM>, a distal end <NUM>, a proximal end <NUM>, and an interior cavity <NUM>, wherein the interior cavity <NUM> may be completely defined by the interior surface <NUM> of the side wall <NUM>, or may be defined by the interior surface <NUM> of the side wall <NUM> and the interior surface <NUM> of the distal end <NUM>. At least a part of the frame side wall <NUM> includes both the support element <NUM> and the absorbent element <NUM>. In some embodiments (as can be seen in <FIG>), the support element <NUM> is disposed radially outside of the absorbent element <NUM>. The support element <NUM> may extend the entirety of the side wall (from proximal end to distal end; outside of the absorbent element <NUM>, or less than the entirety. In some embodiments, the support element <NUM> is disposed radially inside of the absorbent element <NUM>. For example, <FIG> shows an embodiment wherein the entirety of the support element <NUM> is disposed radially inside of the absorbent element <NUM>. In any embodiment having at least a portion of the support element radially inside of the absorbent element <NUM>, the support element <NUM> may extend the entirety of the side wall (from proximal end to distal end) radially inside of the absorbent element <NUM>, or less than the entirety. In some embodiments (as can be seen in <FIG> and <FIG>), the support element <NUM> may include a portion disposed radially outside of the absorbent element <NUM> and a portion disposed radially inside of the absorbent element <NUM>. For example, the embodiment shown in <FIG> includes an outer support element portion 17A and an inner support element portion 17B, which portions are independent of one another. The embodiment shown in <FIG> includes an outer support element portion 17A and an inner support element portion 17B, and also includes a proximal end support element portion 17C that is connected to the other portions 17A, 17B. In other words, the support element <NUM> embodiment shown in <FIG> extends from a radially outer portion 17A (e.g., disposed on the interior surface <NUM> of the side wall <NUM>), over the proximal end surface <NUM> (e.g., proximal end portion 17C), to a radially inner portion 17B (e.g., disposed on the exterior surface <NUM> of the side wall <NUM>). The support element <NUM> may extend around the entire circumference of the menstrual device <NUM>.

As described above, some embodiments of the present menstrual device include a frame <NUM> having a support element <NUM> that is configured to elastically self-expand. In some of these embodiments, it is the support element <NUM> that solely provides the radial expansion force (described below) adequate to cause the menstrual device <NUM> to elastically self-expand from a compact configuration to a deployed configuration or an at rest configuration. Also as described above, some embodiments of the present menstrual device include a frame <NUM> having an absorbent element <NUM> that is configured to elastically self-expand. In some of these embodiments, it is the absorbent element <NUM> that solely provides the radial expansion force adequate to cause the menstrual device <NUM> to elastically self-expand from a compact configuration to a deployed configuration or an at rest configuration. In still other embodiments of the present menstrual device <NUM>, the support element <NUM> and the absorbent element <NUM> both provide radial expansion forces and thereby collectively provide the radial expansion forces necessary to cause the menstrual device <NUM> to elastically self-expand from a compact configuration to a deployed configuration or an at rest configuration.

The mechanical material properties of the frame material(s) that enable the frame <NUM> to elastically expand from a compact configuration to an expanded configuration may be described in terms of "expansion forces". To illustrate, consider a frame <NUM> maintained in a deployed configuration (i.e., wherein the menstrual device <NUM> assumes a volume less than the volume of the same device in an at rest configuration). Body wall surfaces <NUM> (i.e., vaginal wall surfaces) in contact with the menstrual device <NUM> prevent the menstrual device <NUM> from assuming its fully expanded configuration, and thereby maintain the menstrual device <NUM> in the partially compressed deployed configuration. As a result, the expansion forces <NUM> that would otherwise cause the menstrual device <NUM> to elastically expand to an at rest configuration, now act against the body wall surfaces <NUM>. Those expansion forces <NUM>, which are quantifiable, are at least a part of the mechanism that enables the menstrual device <NUM> to be maintained at a particular position within the user's vagina. It should be noted from the above that menstrual devices <NUM> according to the present disclosure are intended to assume an expanded configuration, albeit one that is partially compressed configuration (i.e. a deployed configuration), during in vivo use. The expansion forces <NUM> are described as being "at least part of the mechanism" that enables the device to be positionally retained because other factors may also play a part in retaining the device; e.g., the coefficient of friction of the exposed surface of the seal layer <NUM>, the coefficient of friction of the body wall surface <NUM>, the geometric shape of the menstrual device <NUM>, etc. For the present menstrual device embodiments, the frame <NUM> is chosen to have mechanical material properties (as described above) that produce expansion forces adequate to retain the device <NUM> in vivo in a deployed configuration, while at the same time such expansion forces <NUM> are preferably below a magnitude that: a) would cause user discomfort; b) inhibit or prevent the menstrual device <NUM> from being placed in a compact configuration (e.g., for insertion purposes with or without an applicator); and/or c) inhibit removal of the menstrual device from in vivo deployment. The expansion forces <NUM> produced by the frame material are further discussed below in the context of an applicator device that may be used with the present menstrual device <NUM>.

As shown in <FIG>, the menstrual device further includes a flange <NUM> that further mitigates against leakage. Flange <NUM> provides a gasketing effect thereby assisting with creating a seal with the vaginal wall. Flange <NUM> is flexible such that it is configurable in a compact form (i.e. it can fold or scrunch). In some embodiments, flange <NUM> extends outwardly from exterior surface <NUM> of the menstrual device <NUM>. In further embodiments, flange <NUM> extends outward and upward from the exterior surface <NUM> and proximal surface <NUM>. In other embodiments, flange extends outward and downward from the exterior surface <NUM> and proximal surface <NUM>. As flange <NUM> is flexible, it can be dynamic (i.e. move upward/downward, outward/inward) depending on placement within the vaginal wall and other factors such as the user's physical movement and/or the dynamic state of other organs/tissues. In some instances, flange <NUM> can actually create a dam and not only assist in collecting fluid within the menstrual device <NUM>, but above the proximal surface <NUM>.

Flange <NUM>, as shown in <FIG>, and <FIG>, has multiple flanges 13A, 13B, and 13C. These additional flanges further assist in creating a seal with the vaginal wall, due to dynamic conditions experienced over time. Flanges are separated by grooves <NUM>, 15A, 15B, and 15C. Flanges <NUM> and grooves <NUM> can be discrete from each other, continuous about the periphery of the menstrual device <NUM>, and/or varied, patterned, etc. Flanges <NUM> are generally sized to extend outward widthwise or depthwise up to <NUM> inches (<NUM>), less than <NUM> inches (<NUM>), or between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>). Flanges <NUM> are generally sized to extend in length along the lengthwise axis up to <NUM> inches (<NUM>), less than <NUM> inches (<NUM>), or between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>). Grooves <NUM> have similar range of sizes.

As depicted in <FIG>, flanges <NUM> extend from frame <NUM>. Seal layer <NUM> extends up to the inferior-most flange 13B. Although seal layer can extend and at least partially cover portions of a flange or flanges (or groove or grooves), it is preferred at least a portion of a flange (or flanges) is not covered by seal layer <NUM> such that, depending on how the menstrual device <NUM> is positioned within the vaginal canal, it enables further fluid collection through the permeable frame <NUM>. As depicted in <FIG>, flanges extends from support element <NUM>. In embodiments where the seal layer <NUM> is the supper element <NUM>, the flange <NUM> (or flanges) extends from the seal layer <NUM>/support element <NUM>.

As shown in <FIG> and <FIG>, the menstrual device <NUM> includes flange <NUM> in the form of a pocket or gusset. Optionally, one or more support ribs <NUM> (as shown in <FIG>) provide added resilience to flange <NUM> to mitigate against bypass leakage (by improving the seal created with the vaginal wall).

The support element <NUM> and the absorbent element <NUM> may be attached to one another directly or indirectly. Non-limiting examples of acceptable attachment mechanisms include adhesive, mechanical fasteners, bonding, etc. An example of an indirect attachment mechanism includes both the support element <NUM> and the absorbent element <NUM> being attached to the removal element <NUM>, but not directly to each other.

The seal layer <NUM> is disposed on at least a portion of the exterior of the menstrual device <NUM>. In those embodiments where the support element <NUM> is disposed radially outside of the absorbent element <NUM>, the seal layer <NUM> may be disposed radially outside of the support element <NUM> (e.g., see <FIG>, <FIG>). In these embodiments, the seal layer <NUM> may be disposed on the entirety of the exterior surface of the support element <NUM>, or on less than the entirety of the support element <NUM>. In those embodiments wherein the support element <NUM> extends less than the entire distance between the proximal end and the distal end of the menstrual device, the seal layer may also be disposed on a portion of the exterior surface <NUM> of the side wall <NUM>. In those embodiments wherein the support element <NUM> is only disposed radially inside of the absorbent element <NUM>, the seal layer <NUM> may be disposed on the entirety of the exterior surface <NUM> of the side wall <NUM> (e.g., the entire distance between the proximal end and the distal end, and contiguous with the absorbent element <NUM>; see <FIG>), or less than the entirety of the exterior surface <NUM> of the side wall <NUM>. In some embodiments, the seal layer <NUM> may cover at least a portion of the proximal end surface <NUM>. In those embodiments wherein the frame <NUM> includes a distal end exterior surface <NUM>, the seal layer <NUM> may also be disposed on the distal end exterior surface <NUM>.

The removal element <NUM> is typically disposed at the distal end <NUM> of the menstrual device <NUM> and is configured to facilitate removal of the menstrual device <NUM> from the user's vagina. The removal element <NUM> may be a component independent of the frame <NUM> or seal layer <NUM>, but attached to one or both of the frame <NUM> and seal layer <NUM>. An acceptable example of an independent removal element <NUM> is a string. The use of strings as a menstrual device <NUM> (e.g., a tampon or menstrual cup) is well known in the art, and therefore further description is not provided herein. In some embodiments, the removal element <NUM> may be incorporated into the frame <NUM> or seal layer <NUM>; an extension of the frame <NUM> or the seal layer <NUM>, or some combination thereof.

The removal element <NUM> is typically disposed at the distal end <NUM> of the menstrual device <NUM> and is configured to facilitate removal of the menstrual device <NUM> from the user's vagina. The removal element <NUM> may be a component independent of the frame <NUM> or seal layer <NUM>, but attached to one or both of the frame <NUM> and seal layer <NUM>. In regards to the removal element <NUM> being attached to the frame <NUM>, the removal element <NUM> may be attached to one or both of the support element <NUM> and the absorbent element <NUM>. An acceptable example of an independent removal element <NUM> is a string. The use of strings as a menstrual device <NUM> (e.g., a tampon or menstrual cup) is well known in the art, and therefore further description is not provided herein. In some embodiments, the removal element <NUM> may be incorporated into the frame <NUM> or seal layer <NUM>; an extension of the frame <NUM> or the seal layer <NUM>, or some combination thereof.

In some embodiments, the seal layer <NUM> can be folded over itself and sealed to itself (in its entirety or minimally at the end points <NUM> of the fold(s) <NUM> to provide multiple layers in the seal layer <NUM>. End points <NUM> are a single node or describe a peripheral end point for attachment. One skilled in the art understands that in any embodiment having a seal layer <NUM>, end points <NUM> are minimally included (i.e., an upper end point that is discrete or peripheral, and a lower end point that is discrete or peripheral). This is advantageous in that it provides redundancy in impermeability, particularly at the distal end <NUM>, and it also improves the strength of seal layer. The seal layer strength is further advantageous when positioned in the bottom region of the menstrual device and can ultimately become the removal element in its entirety. In some embodiments, a further removal element (i.e. a string, coated string, braided string) can be attached to the folded seal layer <NUM>. The folded seal layer at least about the bottom region (or in some embodiments, merely the distal exterior surface <NUM>) provides added strength as it distributes what is typically a tensile load on the removal element <NUM> with through shear.

As shown in the embodiment in <FIG>, seal layer <NUM> extends beyond the distal end <NUM>. In such embodiments, seal layer <NUM> provides covering over a removal element <NUM>, can be used to fasten the removal element <NUM> to the menstrual device <NUM>, and/or be sealed to form a further fluid collection reservoir <NUM>.

In other embodiments, the seal layer <NUM> and/or support layer <NUM> extend to form a ring <NUM> with hole <NUM>, as shown in <FIG>. A removal element <NUM> can be fastened to the ring via a knot <NUM>. In alternate embodiments, as shown in <FIG>, a removal element <NUM> is stitched or otherwise attached to the menstrual device. Removal element <NUM> is attached via one or more knots, and can be attached along the lengthwise axis (as shown in <FIG>), and/or can be attached just above either a step-change <NUM> in the cavity <NUM> and/or just above the bottom of the cavity <NUM>. Attaching the removal element <NUM> as such improves the tensile strength.

All embodiments as contemplated in the present disclosure of the removal element <NUM> have been tested and meet the FDA's tampon requirements for having a tensile strength of at least eight pounds (i.e. stitched, knotted in the cavity, applied to the menstrual device by biocompatible adhesive, and/or tied to ring <NUM>).

In some embodiments of the present disclosure, the menstrual device <NUM> may include a second absorbent element <NUM> (independent of the absorbent element <NUM>) disposed within the interior cavity <NUM> of the frame <NUM> (e.g., see FIG. An example of a second absorbent element <NUM> is a tampon pledget, and can include materials such as rayon (multilobal, single lobal, cotton and/or combinations thereof). Tampon pledgets are well known in the art and the present menstrual device <NUM> is not limited to including any particular type of tampon pledget (i.e. including those with or without coverstock, formed wadded material and/or including discrete layers or pads). The second absorbent element <NUM> may be coupled to the frame <NUM> using one or more techniques; e.g., by adhesive, ultrasonic bonding, stitching, mechanical features, etc..

In some embodiments, menstrual device <NUM> includes a support element <NUM> and either absorbent layer <NUM> or second absorbent element <NUM>. In some embodiments, the support element <NUM> is elastic and as the absorbent (element <NUM> or layer <NUM>) absorbs fluid, the support element <NUM> expands. In such embodiments, support element helps create a seal and thus mitigates against bypass leakage.

In some embodiments of the present disclosure, the menstrual device <NUM> may include an absorbent article <NUM> disposed within the interior cavity <NUM> of the frame <NUM> (e.g., see <FIG>). An example of an absorbent article <NUM> is a tampon pledget. Tampon pledgets are well known in the art and the present menstrual device <NUM> is not limited to including any particular type of tampon pledget. The absorbent article <NUM> may be coupled to the frame <NUM> using one or more techniques; e.g., by adhesive, ultrasonic bonding, stitching, mechanical features, etc..

In addition to, or as an alternative to the absorbent article <NUM>, the menstrual device <NUM> may include one or more absorbent materials <NUM> disposed within the interior cavity <NUM>; e.g., disposed on at least part of the interior surface <NUM> of the frame side wall <NUM> defining the interior cavity <NUM> (e.g., see <FIG>) The absorbent material(s) <NUM> may comprise one or more material types; e.g., wood pulp, rayon, cotton, natural or synthetic nonwoven materials, super-absorbent materials (e.g., fibers, films, particles), nanocellulose materials, foams, or any combination thereof. The absorbent material(s) <NUM> is preferably medical grade and/or biocompatible.

Now referring to <FIG>, in some instances the present menstrual device <NUM> may be configured for use with an applicator <NUM> that facilitates deployment of the menstrual device <NUM> within the user's vagina. The combination of applicator <NUM> and menstrual device <NUM> may be referred to herein as a menstrual device system. Although the present menstrual device <NUM> is not limited to use with any particular type of applicator <NUM>, an example of an acceptable type applicator <NUM> is a plunger type applicator having a barrel <NUM> and a plunger <NUM>. The barrel <NUM> has a tubular configuration with an interior cavity <NUM> extending between an insertion tip end <NUM> and a plunger end <NUM>. The insertion tip end <NUM> may have a plurality of slits <NUM> that form petals <NUM> that normally assume a radially inward geometry to give the insertion end a tapered configuration. The plunger <NUM> is receivable within the barrel interior cavity <NUM> and has a mating geometry relative to the barrel interior cavity <NUM> such at least a portion of the plunger <NUM> can be inserted into the barrel interior cavity <NUM>; i.e., the plunger <NUM> can be moved axially into the barrel interior cavity <NUM>. A menstrual device <NUM> disposed in a compact configuration can be disposed within the barrel interior cavity <NUM>. Axial insertion of the plunger <NUM> into the barrel interior cavity <NUM> will axially move the menstrual device <NUM> against the petals <NUM>. Continued axial insertion of the plunger <NUM> will cause the petals <NUM> to deflect radially outward and the menstrual device <NUM> to eject from the barrel <NUM>.

The "Ejection Force" is described as the force required to eject a menstrual device <NUM> from the applicator. The Ejection Force can be determined using a scale such as a Tronix scale model #WI-<NUM>, and an Instron model <NUM> with a <NUM> N load cell, using a rate of <NUM> in/min, and by following this procedure. All menstrual device <NUM> samples tested had a small amount of lubricant (K-Y True Feel Silicone Lubricant) applied to their periphery before being loaded into the applicators, as discussed below. The amount of lubricant included was minimal, such that upon ejection, no lubricant was noticeable by touch.

In those embodiments wherein the present menstrual device <NUM> is intended to be used with an applicator <NUM> (e.g., the same as or similar to the applicator described above), the frame material(s) is chosen to have mechanical material properties that produce expansion forces below which the menstrual device <NUM> is detrimentally inhibited from being ejected from the applicator <NUM>; i.e., the frame material expansion forces do not bind the menstrual device <NUM> within the applicator barrel <NUM>. In such embodiments, the seal layer <NUM> material properties (e.g., surface finish) and the applicator barrel <NUM> material properties (e.g., surface finish) may be chosen to complement each other to facilitate ejection of the menstrual device <NUM> from the applicator barrel <NUM>. For instance, the seal layer <NUM> is a smooth and/or slippery material such that its coefficient of friction is less than that of the frame <NUM> material. As such, seal layer <NUM>, when applied to frame <NUM>, can, in embodiments including an applicator <NUM>, reduce the ejection force of the menstrual device <NUM> from applicator <NUM> to be less than <NUM> ounces, less than about <NUM> ounces, preferably less than <NUM> ounces and more preferably, less than or equal to about <NUM> ounces.

As shown below in Table <NUM>, applicators used to confirm ejection force values included the PLAYTEX GENTLE GLIDE ultra, having an inside barrel diameter of <NUM>, the PLAYTEX SPORT super plus, having an insider barrel diameter of <NUM>, and the KIMBERLY CLARK POISE IMPRESSA applicator, having an insider barrel diameter of <NUM>. In short, applicators having an inside barrel diameter of between about <NUM> and about <NUM> are suitable for the menstrual device <NUM> of the present disclosure, or between about <NUM> and about <NUM>, or between <NUM> and about <NUM>. Various sizes of menstrual device <NUM> were used, including those with lengths of <NUM> inches (<NUM>) and <NUM> inches (<NUM>), having proximal end widths of <NUM> inches (<NUM>) and <NUM> inches (<NUM>), a cavity length of <NUM> inches (<NUM>), <NUM> inches (<NUM>) and <NUM> inches (<NUM>), with a maximum cavity radius at the proximal end of <NUM> inches (<NUM>), <NUM> inch (<NUM>) and <NUM> inches (<NUM>). If not otherwise specified, the samples included a seal layer <NUM> made from a biocompatible film. At least five samples of each embodiment of the menstrual device <NUM> were tested.

As shown in the embodiment in <FIG>, the ejection force changes during the ejection process, or as a function of time or length (note: length and time are related due to the <NUM> in/min rate, and the length of the stroke correlates to the length of the plunger moving against the menstrual device). <FIG> (reference numeral <NUM>) describes various stages of ejection, starting with the plunger <NUM> initially contacting and depressing the menstrual device <NUM> at a force that exceeds that of the friction between the exterior surface of the menstrual device <NUM> and the interior surface of cavity <NUM> of the applicator <NUM> barrel <NUM> (see reference numeral <NUM>). The vertical axis <NUM> describes ejection force in ounces, while the horizontal axis <NUM> describes extension of the plunger in inches (mm). Once the force exerted by the plunger <NUM> exceeds this static friction force, the ejection force drops slightly as the menstrual device <NUM> begins sliding through the applicator barrel <NUM> prior to making contact with and opening the insertion tip end <NUM> of the applicator (see reference numeral <NUM>). As the menstrual device <NUM> approaches the insertion tip end <NUM> and begins to apply pressure against the insertion tip end <NUM>, the force increases until the insertion tip end <NUM> has been opened (see reference numeral <NUM>). Once the insertion tip end <NUM> is opened, the menstrual device <NUM> starts to eject from the applicator at a reduced force (i.e. "self-ejection"; see reference numeral <NUM>). Lastly, as shown by reference numeral <NUM>, the menstrual device <NUM> goes through the final stages of ejection at a low level of force.

The menstrual device <NUM> has numerous distinct ejection characteristics, including the ability to self-eject from the applicator <NUM> after the plunger <NUM> has moved at least about an inch (<NUM>). The plunger's <NUM> movement of at least about an inch (<NUM>) has fully opened the applicator insertion tip <NUM>. The plunger's <NUM> movement of at least about an inch (<NUM>) has engaged the menstrual device <NUM> such that a substantial portion of the menstrual device <NUM> has been pushed beyond the applicator <NUM> insertion tip end <NUM>.

Various embodiments of the menstrual device <NUM> of the present disclosure include various features. For instance, menstrual device <NUM> has a frame <NUM> which is optionally a support member <NUM> and absorbent material (<NUM> or <NUM>). A single material can act as either or both of a support member <NUM> and a seal layer <NUM>, and in further embodiments, provides all or a portion of removal element <NUM>.

While some of the examples described herein related to uses of a device configured to be deployed within a body cavity, aspects of the disclosure may be applied in other types of environments where fluid sealing, absorption, or collection may be needed; e.g., incontinence devices, etc..

Claim 1:
A menstrual device comprising:
a frame (<NUM>) having a side wall (<NUM>) with an exterior surface (<NUM>) and an interiorsurface (<NUM>), the side wall (<NUM>) extends between a proximal end (<NUM>), and a distal end (<NUM>), and the interior surface (<NUM>) at least in part defines an cavity (<NUM>); and
a fluid barrier seal layer (<NUM>) disposed on the exterior surface (<NUM>) of the side wall (<NUM>), the fluid barrier seal layer (<NUM>) attached directly to the exterior surface (<NUM>) about at least a first end point;
wherein the menstrual device collects fluid,
wherein the menstrual device has a device length defined by a central vertical axis between the proximal end (<NUM>) and the distal end (<NUM>),
wherein the menstrual device is configurable in a compact configuration and in an expanded configuration, and in the expanded configuration the cavity (<NUM>) has a volume greater than zero,
wherein the cavity (<NUM>) has a step-change (<NUM>) in a widthwise or depthwise dimension between the proximal end (<NUM>) and the distal end (<NUM>).