MENSTRUAL COLLECTION DEVICE, APPLICATOR AND A METHOD OF INSERTING A MENSTRUAL COLLECTION DEVICE WITH AN APPLICATOR
20230019578 ยท 2023-01-19
Inventors
- Cynthia Belardo (West Lafayette, IN, US)
- Drew Jarvis (Bloomington, IN, US)
- Benjamin Ettinger (Evergreen, CO, US)
- Sean Kleinschmidt (Carmel, IN, US)
- Grant Chapman (Indianapolis, IN, US)
Cpc classification
International classification
Abstract
A menstrual collection device, an applicator and a method of inserting a menstrual collection device within a vaginal canal. The menstrual collection device includes ribs and thin-walled panels or membranes that are recessed from, extend between and are formed integral to the ribs. The ribs and thin-walled panels or membrane allow for the menstrual collection device to hold its shape and collect fluid while still being able to be folded to reduce the surface area of the collection device and fit within the applicator. The applicator tip is flexible such that it allows for menstrual collection device to pass therethrough while still applying a force by to the menstrual collection device to aid in the opening of the collection device to a fully open state.
Claims
1. An applicator, comprising: a housing including a sidewall that is delimited at a first end by a tip and a second end by a base, and has a first surface and a second surface with the second surface defining a cavity that extends within the housing from the base to the tip; and a plunger that is arrangeable within the cavity of the housing.
2. The applicator of claim 1, wherein the tip of the housing has a plurality of projections that extend in a curved manner from the sidewall toward an apex of the tip.
3. The applicator of claim 2, wherein the projections are spaced from each other by gaps that extend into an opening at an end of each of the projections.
4. The applicator of claim 3, wherein the ends of each of the projections are rounded.
5. The applicator of claim 1, wherein the base of the housing has a cylindrical shape that flares outwardly from the sidewall of the housing such that an outer periphery of the base has a greater circumference than a circumference of the first surface of the sidewall of the housing.
6. The applicator of claim 1, wherein at least the sidewall of the housing is comprised of a first material and the projections of the housing are comprised at least in part of a second material that is different from the first material with the second material has a modulus of elasticity that is greater than that of the first material.
7. The applicator of claim 6, wherein the second material has elastomeric properties such that the projections are flexible in an outward direction, when a force is applied thereto, to expand the opening at the tip and return to the projections to an original resting state while applying a compressive force.
8. The applicator of claim 1, wherein the plunger includes cylindrical main body that extends between a first end and a second end, the first end including a cavity that extends toward the second end thereof and the second end defined by a base that has an outer periphery that is greater than an outer periphery of the main body.
9. The applicator of claim 1, wherein the cylindrical main body of the plunger has a length that is greater than the length of the cavity of the housing of the applicator.
10. A method of inserting a menstrual collection device into a vaginal canal, the method comprising: providing a menstrual collection device comprising a housing that is open at a first end and tapers to a base at a second end from which a stem extends, the housing defines a cavity therein and includes a frame having a first thickness, panels having a second thickness extending between the frame and a rim extending from the frame to delimit the first end; providing an applicator comprising a housing including a sidewall that is delimited at a first end by a tip and a second end by a base, and the housing having a first surface and a second surface with the second surface defining a cavity that extends within the housing from the base to the tip and a plunger that is arrangeable within the cavity of the housing; folding the menstrual collection device; arranging the menstrual collection device that is folded within the cavity of the housing of the applicator; inserting the plunger within the cavity of the applicator; inserting the applicator within a vaginal cavity; moving the plunger towards the tip of the housing of the applicator such that the applicator contacts the menstrual collection device and the menstrual collection device contacts the projections of the housing of the applicator; and pushing the plunger with a force applied thereto that causes the projections to move outwardly and beyond the first surface of the housing, at least in part, to expand an opening at the tip of the housing of the applicator and allow the menstrual collection device to pass through the opening while compressing the collection device to cause the menstrual collection device to expand from being folded to a fully open state within the vaginal canal.
11. The method of claim 10, wherein the tip of the applicator includes a plurality of projections that extend in a curved manner from the sidewall toward an apex of the tip and are spaced from each other by gaps that extend into an opening at an end of each of the projections.
12. The method of claim 10, wherein the menstrual collection device has a frame that includes a first rib, a second rib, a third rib and a fourth rib, and the first rib extends vertically about the housing, the second rib is spaced from the first rib and extends vertically about the housing, the third rib extends from a first end of the first rib and a first end of the second rib continuously about an upper end of the housing and the fourth rib extends from a second end of the first rib and a second end of the second rib continuously about a lower end of the housing, and the panels are recessed from, extend between and are formed integral to the first rib, the second rib, the third rib and the fourth rib.
13. The method of claim 10, wherein the first thickness of the frame is greater than the second thickness of the panels.
14. The method of claim 11, wherein the projections apply a force on the collection device which translates to the rim thereof, causing the rim to expand from a folded state to a fully open state to create a seal with the vaginal cavity.
15. The method of claim 14, wherein the projections return to an original resting state when no force is applied thereto.
16. A menstrual collection device, comprising: a housing that is open at a first end and tapers to a base at a second end from which a stem extends, the housing defines a cavity therein and includes a frame having a first thickness, panels having a second thickness extending between the frame and a rim extending from the frame to delimit the first end.
17. The menstrual collection device of 16, wherein the frame includes a first rib, a second rib, a third rib and a fourth rib, and the first rib extends vertically about the housing, the second rib is spaced from the first rib and extends vertically about the housing, the third rib extends from a first end of the first rib and a first end of the second rib continuously about an upper end of the housing and the fourth rib extends from a second end of the first rib and a second end of the second rib continuously about a lower end of the housing.
18. The menstrual collection device of 16, wherein the panels are recessed from, extend between and are formed integral to the first rib, the second rib, the third rib and the fourth rib.
19. The menstrual collection device of 16, wherein the first thickness of the frame is greater than the second thickness of the panels.
20. The menstrual collection device of 16, wherein the rim and a sidewall of the collection device that includes the frame and the panels extend in a sloped manner such that the rim is a first height at a first side of the menstrual collection device and a second height, which is greater than the first height, at a second side of the menstrual collection device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT DISCLOSURE
[0040] With reference now to the drawings and in particular
[0041]
[0042] As can be seen, for example, in
[0043] In an embodiment of the present disclosure, the first thickness is about 1.5 mm and the second thickness is about 0.75 mm, providing a ratio of a thickest portion of the housing 102 and a thinnest portion of the housing 102 of about 2 mm (1.5 mm/0.75 mm). Alternatively, according to other embodiments, the first thickness can be, for example, 1.0 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, etc., the second thickness can be, for example, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, etc. and ratios of a thickest and thinnest portions of the housing 102 are about 1.2, 1.4, 1.6, 1.8, 2.2, 2.4, 2.6, 2.8, 3.0, 3.5, 4.6, etc.
[0044] The inner surface 128 defines a period fluid collection volume of 25 ml, providing a ratio of the period fluid collection volume to a thinnest portion of the housing 102 of about 31,000 mm.sup.2 (25 ml/0.75 mm). Other period fluid collection volumes may be provided, such as 10 ml, 15 ml, 20 ml, 30 ml, 35 ml, etc. and ratios of the period fluid collection volume to a thinnest portion of the housing 102 of about 13.00 mm.sup.2, 15,000 mm.sup.2, 20,000 mm.sup.2, 35,000 mm.sup.2, 40,000 mm.sup.2, 50,000 mm.sup.2, etc.
[0045] While the cavity 109 that is defined by the inner surface 128 can hold roughly 25 ml of fluid, the representative embodiments should not be limiting with respect to the volume of liquid that can be held by the collection device 100. The collection device 100 can be sized to hold any amount of liquid desired. For example, the cavity 109 could be smaller to hold 5 ml of fluid or larger to holder 30 ml of fluid.
[0046] The rim 114 extends from the third rib 120 and delimits the open end 108 of the collection device 100. As can be seen, for example, in
[0047] As can be seen in
[0048] The menstrual collection device 100 can be comprised of silicone or another medical grade material that allows for flexibility and bending to permit the collection device to be folded while at the same time having elastomeric properties to return to an original, fully open state when the collection device is not being compressed and/or folded.
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[0050] The housing 202 includes a cylindrical sidewall 206 that is delimited at a first end by a tip 208 and at a second end by a base 210. The sidewall 206 includes an external surface 212 and an internal surface 214 with the internal surface 214 defining a cavity 216 that extends within the housing 202 from the base 210 to the tip 208.
[0051] The tip 208 has a hemispherical shape that is defined by a plurality of flexible projections or flaps 218 that extend in a curved manner from the sidewall 206. As shown, the projections 218 extend directly from the sidewall 206. The projections or flaps 218 are spaced from each other by gaps 220 that extend into an opening 222 at the distal end of the housing 202. The flaps 218 each extend from the sidewall 206 of the housing 202 and include rounded edges 224 that delimit each of the projections or flaps 218. While three flaps are shown, it is noted that any number of flaps can extend from the sidewall of the housing to define the tip.
[0052] The projections or flaps 218 are comprised, at least in part, of a material that has elastomeric properties to allow for flexibility of the projections or flaps 218 in an outward direction to expand the opening at the tip 208, when a force is applied thereto, to allow a menstrual collection device 100 to pass through the tip 208. As the menstrual collection device 100 passes through the opening 222, the projections or flaps 218 apply a force on the base 104, sidewalls 128 and/or ribs 116, 118, 120, 122, which translates to the rim 114, causing the rim 114 to expand from a folded state to a fully open state to create a seal with the vaginal cavity without the need to substantially adjust the collection device 100. Once a force is no longer applied to the projections or flaps 218 to push the menstrual collection device 100 therethrough, the projections or flaps 218 automatically and instantly return to their original resting state or closed position.
[0053] A combination of the durometer, material and geometry of the tip 208 allow for the menstrual collection device 100 to pass therethrough and for the tip 208 of the applicator 200 to return to the closed state once the collection device 100 passes therethrough.
[0054] As illustrated in
[0055] The plunger 204 as can be seen, for example, in
[0056] The plunger 204 has a length such that the plunger 204 extends beyond the distal end of the housing 202 of the applicator 200 tip when the plunger is fully inserted within the housing 202 of the applicator 200. By extending the plunger 204 beyond the tip of the housing 202, which greatly improves the success rate of deployment of the collection device 100 to a fully open state.
[0057] As shown in
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[0059] The housing 302 includes a sidewall 306 that is cylindrical and is delimited at a first end by a tip 308 and at a second end by a base 310. A cavity 313 extends within the housing 302 from the base 310 to the tip 308. The tip 308 has a hemispherical shape that is divided into a plurality of substantially equivalent projections or flaps 314 with gaps 316 that extend therebetween. As shown in
[0060] The projections or flaps 314 are comprised, at least in part, of a material that has elastomeric properties to allow for flexibility of the projections or flaps 314 in an outward direction increase the size of the opening 318 at the tip 308, when required, to allow a menstrual collection device 100 to be expelled through the tip 308. Like the applicator 200, the projections or flaps 314 apply a force on the base 104 of the collection device 100 and the sidewalls thereof which translates to the rim 114, causing the rim 114 to expand from a folded state to a fully open state to create a seal with the vaginal cavity without the need to substantially adjust the collection device 100. Once a force is no longer applied to the projections or flaps 314 to push the menstrual collection device 100 therethrough, the projections or flaps 314 automatically and instantly return to their original resting state or closed position.
[0061] As illustrated in
[0062] As can be seen in
[0063] To further align and stabilize the plunger 304 within the housing 302, flexible tabs 330 are fixed, at least in part, the outer surface 320 of the sidewall 306 of the housing 302, above the intersection of the sidewall 306 and the base 310. The tabs 330 are configured to interact with the plunger 304 to retain the plunger 304 within the housing cavity 324 when a force is applied to the plunger 324 in a direction toward the tip 308 of the housing 302 to push the menstrual collection device 100 through the opening 318 at the tip 308 of the housing 302 and into the vaginal canal.
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[0066] To begin, as can be seen in
[0067] Next, as depicted in
[0068] A top view of the completed punch-down fold is illustrated in
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[0070] For the folding step, a user squeezes the upper rim 114 of the collection device 100 at midpoints between the first rib 116 and the second rib 118 together. The midpoint of the first rib 116 is then pushed inward and the entire top of the menstrual collection device 100, including the pinched rim 114, are folded down over the first rib 116. If done correctly, each side of the membrane 112 of the menstrual collection device 100 should extend outwardly in a diamondlike shape to form a protruding side as shown in
[0071] Next, as illustrated in
[0072] After completing the diamond fold, the user can then place the menstrual collection device 100 within the cavity of the applicator body 202, 302 or directly into the vaginal canal. To facilitate the insertion either into the applicator body 202, 302 or vaginal canal, the user can ensure the diamond fold is firmly pinched. The steps and process of inserting the folded collection device 100 into the applicator body 202, 302 are substantially the same as those discussed above for the punch-down fold.
[0073] To insert the menstrual collection device 100 into the applicator body 202, as shown in
[0074] The plunger 204 further aids to orients the collection device 100 within the applicator 100 and reduce or minimize friction between the collection device 100 and inner wall 214 of the housing 202 to reduce the surface area of the collection device 100 in contact with the inner wall 214 by nesting or arranging within the cavity 238 of the plunger the stem 106 and at least part of the base 104. It is noted that while the applicator 200 is depicted in conjunction with the collection device 100 that the applicator 300 could alternatively be used.
[0075] As shown in
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[0077] Although the description above and accompanying drawings contains much specificity, the details provided should not be construed as limiting the scope of the embodiments, but merely as describing some of the features of the embodiments. The description and figures should not to be taken as restrictive and are understood as broad and general teachings in accordance with the present invention. While the embodiments have been described using specific terms, such description is for illustrative purposes only, and it is to be understood that modifications and variations to such embodiments, including, but not limited to, the substitutions of equivalent features and terminology may be readily apparent to those of skill in the art based upon this disclosure without departing from the spirit and scope of the invention.