Contraception, collection, and testing device and methods of using same

Abstract

Disclosed herein are embodiments of artificial contraception, semen collection, and semen acidity indicator devices and systems. Some embodiments of such devices are comprised of a convenient, wearable adhesive member that has a pocket or other receptacle for collecting bodily fluid.

Description

JRF.OOIWO PATENTCONTRACEPTION, COLLECTION, AND TESTING DEVICE AND METHODS OFUSING SAMEINCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. In particular, this application claims priority to the U.S. Provisional Application 63 / 727363. filed December 3, 2024, which is incorporated by reference herein in its entirety as if fully set forth herein.FIELD

[0002] Embodiments of the present disclosure relate to contraception and prophylactic devices, for example, artificial contraception and prophylactic devices, as well as semen analysis devices.BACKGROUND

[0003] In our sex-forward culture, there are many different sources of contraception. Ultimately, these sources are marketed towards and crafted for those who engage in sexual interactions with multiple partners in an effort to protect against sexually transmitted diseases, as well as unwanted and unexpected pregnancies. These many devices and methods: condoms, diaphragms, oral contraceptives, patches, implants, “pull-out” technique, etc. can be effective and efficient for some, intrusive and hormonally harmful for others, and uncomfortable for most. The unanimous discomfort of condoms, mostly among men, and oftentimes women, is usually due to lack of sensation as the erogenous zones of the penis are covered to help prevent the spread of infection. The sheer amount of coverage causes friction and dryness within the vaginal and anal canals, overall lessening the experience of pleasure for all parties involved.

[0004] While these pitfalls can be worth the potential detriment in some cases, as protection from diseases, infection, and pregnancy is paramount for polygamous relationships — there is a need for pleasure and convenient contraception that exists for monogamous ormarried couples that can be met, if the need for sexually-transmitted disease protection is removed from the equation. Within monogamous relationships, as one and one’s partner only engage in sexual acts with one another, protection from diseases and infections is significantly less necessary — if necessary at all. In this instance, there is a need for artificial contraception that does not have long-lasting hormonal side effects, require a medical procedure, obligate the female partner to prepare, insert, and wear for long periods of time before and after sex, or cover the entire penis resulting in less pleasure for both parties.

[0005] Further, it is also relevant to consider the current options for semen analysis and collection within clinics, hospitals, doctor’s offices, etc. Most facilities offer cup collection or occasionally regular, non-lubricated, condoms for home-use. Cup collection can be messy, stress-inducing as you must have proper aim, and easily contaminated or spilled. Condom collection prolongs the process, and leaves room for much error as the patient must transfer the contents from the condom into a sterile container and then transport it back to the facility. Consequently, there is a need for a simpler, easier system for semen collection. A system that is aim-proof and transfer-free that can be used for solo masturbation, partner- assisted masturbation, as well as home-use via sexual intercourse.

[0006] In a similar vein, we can also consider the rise of male infertility; as sperm quality has declined significantly worldwide. Now, it is extremely common for couples who wish to conceive to check both partner’s fertility. For male partners, there are various manners to test either in-office or via at-home test kits. For home testing, current options are relatively expensive, might require the semen sample to be sent to a lab for analysis, or only indicate sperm count or motility. There are several other components that contribute to sperm quality. One in particular is acidity, which is a crucial factor on the survivability of semen in the vaginal environment, and can also indicate infection, impaired sperm motility, or blockage in the seminal vesicles. Secondly, semen liquefaction (the time it takes for semen to liquify) indicates fertility as well. Abnormal liquefaction time can signify issues such as inflammation, infection, or dehydration. Therefore, a need exists for a convenient, cost-efficient, at-home test with instant results that indicates the acidity of semen as a fertility marker, as well as semen liquefaction.SUMMARY OF SOME EXAMPLE EMBODIMENTS

[0007] Disclosed herein are embodiments of a contraception, prophylactic, fluid collection, and / or fluid testing device (collectively referred to in this disclosure as a contraception device). In some embodiments, the contraception device can include a main body portion, an opening in the main body portion, the opening passing through the main body portion, and a receptacle coupled to the main body portion around the opening. In any embodiments disclosed herein, the device can be configured to be applied to at least a distal end portion of the user’s penis at least around an urethral orifice of the user’s penis so that the opening in the main body portion is generally aligned with the urethral orifice of the user’s penis and the receptacle can be configured to receive a fluid from the user’ s penis in a space within the receptacle.

[0008] Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiments disclosed herein: wherein the receptacle is a pouch configured to receive semen from the user of the device; wherein the receptacle is a pouch configured to receive and contain all or substantially all semen ejaculated by the user; wherein the device is configured to only cover an end portion of the user’s penis; wherein the device is configured to cover, in an operable state, only a portion of a glans penis and urethra of the user's penis; wherein the device is configured to not cover any portion of the user's penis proximal to the glans penis; wherein the device is configured to not cover any portion of a glans-corona, a glans-neck, or a frenulum portion of the user's penis.

[0009] Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiments disclosed herein: wherein the device, in an operable state, is configured to cover at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 50% of an entire length of the user’s penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device, in an operable state, is configured to cover at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 40% of an entire length of the user’spenis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device, in an operable state, is configured to cover at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 30% of an entire length of the user’s penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device, in an operable state, is configured to cover at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 25% of an entire length of the user’s penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device, in an operable state, is configured to cover at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 20% of an entire length of the user’s penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device, in an operable state, is configured to cover at least a portion of a distal end portion of the user’ s penis and to only cover or partially cover at most a distal most 15% of an entire length of the user’s penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device, in an operable state, is configured to cover at least a portion of a distal end portion of the user’ s penis and to only cover or partially cover at most a distal most 10% of an entire length of the user’s penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user's penis and to only cover or partially cover at most 25% of an entire surface of the user's penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user's penis and to only cover or partially cover at most 20% of an entire surface of the user's penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user's penis and to only cover or partially cover at most 15% of an entire surface of the user's penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user's penis and to only cover or partially cover at most 10% of an entire surface of the user's penis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user's penis and to only cover or partially cover from 5% to 20% of an entire surface of the user'spenis (e.g., when the user’s penis is greater than 3 inches long in an erect state); wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user's penis and to only cover or partially cover from 10% to 15% of an entire surface of the user's penis (e.g., when the user’s penis is greater than 3 inches long in an erect state).

[0010] Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiments disclosed herein: comprising one or more flaps extending away from the body portion, the one or more flaps configured to wrap around a portion of the user’s penis; comprising a first pair of flaps and a second pair of flaps extending away from the body portion, wherein at least one of the first pair of flaps and the second pair of flaps are configured to wrap around a portion of the user’s penis; wherein the first pair of flaps and the second pair of flaps are configured to wrap around a portion of a distal end portion of the user's penis; wherein the distal end portion of the user's penis is a glans penis of the user's penis; wherein the first pair of flaps curves upward away from a frenulum of the user's penis toward a shaft of the user's penis when the device is applied to at least the distal end portion of the user's penis; wherein the second pair of flaps extend along a top of a glans penis of the user and extend toward a groin of the user; wherein the first pair of flaps is crescent-shaped; wherein the second pair of flaps is V-shaped; wherein the device is symmetrically shaped about a centerline of the body portion extending from a top of the body portion to a bottom of the body portion; wherein the receptacle is configured to expand to receive fluid from the user’s penis in order to accommodate the fluid; wherein the receptacle is configured to absorb fluid from the user’s penis in order to accommodate the fluid; wherein the main body portion comprises a flexible material; and / or wherein a bottom surface of the main body portion comprises an adhesive material.

[0011] In any embodiments of the contraception device disclosed herein, the device can have a flexible body portion and can use adhesive to attach to a desired body portion of the user - e.g., a penis or a portion of the penis of the user. In some embodiments, the device can include an adhesive patch or cover having a pocket, pouch, cavity, or space for collecting, and / or absorbing bodily fluid. Some embodiments of the device do not provide a reduction,or do not provide a significant reduction, in the risk of sexually-transmitted diseases or infections.

[0012] In some embodiments, a method of contraception disclosed herein can include: adhering a cover over a distal end of a user's penis so that cover covers a distal end of the user's penis but not a glans-corona of the user's penis, so that a receptacle of the cover is positioned over a urethral orifice of the user's penis, and so that no portion of the user's penis proximal to the glans-corona of the user's penis is covered by the cover when the cover is in an operable position on the user's penis. In some embodiments of the method, no portion of a glans-corona, a glans-neck, or a frenulum portion of the user's penis is covered by the cover when the cover is in an operable position on the user's penis.

[0013] Any embodiments of the contraception, prophylactic, fluid collection, and / or fluid testing device can be included in a male-fertility test kit (also referred to in this disclosure as a test kit). In some embodiments, the test kit can include a pH-responsive indicator configured to undergo a color change when exposed to semen having a pH outside a target pH range which can indicate potential fertility problems to the user. Any embodiments of the devices, systems, and methods disclosed herein can include, in additional embodiments, one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiments disclosed herein: wherein the pH-responsive indicator is configured to produce a first color response for semen within the target pH range and a second color response for semen outside the target pH range; wherein the target pH range is between 6 pH and 9 pH; wherein the target pH range is between 6.5 pH and 7.5 pH; wherein the target pH range is between 7 pH and 8 pH; comprising a storage receptacle configured to store the pH-responsive indicator and to dispense the pH-responsive indicator in response to user interaction; wherein the storage receptacle is a dropper bottle comprising a cap. the cap comprising a hole for dispensing the pH-responsive indicator; comprising a device holder configured to secure the contraception device, the device holder comprising an opening configured to receive the receptacle of the contraception device; wherein the device holder comprises a plurality of secondary openings configured to receive a plurality of the flaps of the contraception device to anchor the contraception device to the device holder; wherein the pH-responsive indicator comprises a pre-mixed liquid solution or a powder; wherein the pH-responsive indicator includes a buffering agent or stabilizerconfigured to maintain consistent chromatic behavior in the presence of proteins, enzymes, or biological material present in semen; wherein the pH-responsive indicator comprises a plant- derived chromophore; wherein the pH-responsive indicator comprises a synthetic pH indicator dye.

[0014] In some embodiments, a method of contraception disclosed herein can include: applying any embodiment of the contraception, prophylactic, fluid collection, and / or fluid testing device to a distal portion of a user's penis; collecting semen in the receptacle of the device; removing the device from the user's penis; and dispensing a pH-responsive indicator configured to undergo a color change when exposed to semen having a pH outside a target pH range. In some embodiments, the method can include one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiments disclosed herein: matching an observed color change of the pH-responsive indicator to a color guide to distinguish a fertility result; securing the device to a device holder by inserting the receptacle of the device into an opening of the device holder; securing the device to the device holder by inserting at least one flap of the device into at least one secondary opening of the device holder.

[0015] Some embodiments herein are directed to an artificial contraception device for the penis that does not completely cover the penis. Some embodiments disclosed herein are directed to an adhesive semen collection device. In any embodiments of the device disclosed herein can be configured to be used to collect and / or absorb semen. In any embodiments of the contraception and / or prophylactic device disclosed herein, the device can be configured to be convenient and easy to apply. In any embodiments of the contraception and / or prophylactic device disclosed herein, the device can be a single-use, disposable, artificial contraception device. In any embodiments of the contraception and / or prophylactic device disclosed herein, the device can be a sterile semen collector. In any embodiments of the contraception and / or prophylactic device disclosed herein, the device can be a semen acidity indicator. Any embodiments of the device disclosed herein can be a single-use, disposable, artificial contraception device, a sterile semen collector, and / or a semen acidity indicator. Disclosed herein are embodiments of a convenient, single-use, disposable, artificial contraception device, sterile semen collector, and semen acidity indicator.

[0016] Some embodiments disclosed herein are directed to a semen collection device comprising of an adhesive body portion (also referred to herein as a patch) with a receptacle, which can be a pocket, pouch, cavity, or space for collecting and / or absorbing bodily fluid. Any of the embodiments of the devices disclosed herein can include a semen acidity indicator. The semen acidity indicator can be coupled with the receptacle. In some embodiments, all or a portion of the semen acidity indicator can be in fluid communication with a space inside the receptacle so that, as semen is received or advanced within the receptacle, all or a portion of the semen acidity indicator will be exposed to or in contact with the semen, or at least a sufficient amount of the semen to provide feedback to the user regarding the acidity of the semen.

[0017] Some embodiments disclosed herein are semen acidity indicator testing devices. In some embodiments, the semen acidity indicator device can include an adhesive body portion (also referred to herein as a patch) having a receptacle - e.g., without limitation, a pocket, pouch, cavity, or space for collecting and / or absorbing bodily fluid.

[0018] In some embodiments of the contraception device disclosed herein, the device can include a main body portion (also referred to herein as a patch) made from a medical-grade material that is breathable, waterproof, and soft. The material can contain gentle, reliable, skin-friendly adhesive that leaves no residue and is painless, making it easy to remove. The device can consist of an adhesive patch with a fillable pocket or space to store bodily fluids. Although the act is usually single-use, the adhesive material is removable, if repositioning is required — making the device reusable as well. The flexibility of the material can allow the device to cover and be shaped based on user preference for a universal fit, while also leaving many erogenous zones exposed for optimal pleasure. The fillable pouch will be fastened by well-layered material to ensure an efficient seal (no holes or tears), as well as strong enough to hold about 5ml of fluid, but significantly thin for a pleasurable experience. Lastly, the durable adhesive allows the device to be gently removed and sealed after-use by pinching the specially-shaped adhesive parts together, for semen collection and storage.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Some embodiments of the present disclosure are illustrated as an example and are not limited by the figures of the accompanying drawings, in which like references may indicate similar elements and in which:

[0020] Figure 1 shows a top view of an embodiment of a contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device.

[0021] Figure 2 shows an underside portion of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 1.

[0022] Figure 3 is a left-side perspective view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 1.

[0023] Figure 4 is a right-side perspective view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 1.

[0024] Figure 5A illustrates a bottom, side perspective view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 1 applied to a user’s penis in a first configuration.

[0025] Figure 5B illustrates a top view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 1 applied to the user’ s penis in the first configuration.

[0026] Figure 5C illustrates a bottom, side perspective view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 1 applied to the user’ s penis in a second configuration.

[0027] Figure 5D illustrates a top view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 1 applied to the user’ s penis in the second configuration.

[0028] Figure 6A illustrates a bottom, side perspective view of another embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device applied to a user’ s penis in a first configuration.

[0029] Figure 6B illustrates a top view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 6A applied to the user’s penis in the first configuration.

[0030] Figure 6C illustrates a bottom, side perspective view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 6A applied to the user’s penis in a second configuration.

[0031] Figure 6D illustrates a top view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 6A applied to the user’s penis in the second configuration.

[0032] Figure 7A illustrates a bottom, side perspective view of another embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device applied to a user’s penis.

[0033] Figure 7B illustrates a top view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 7A applied to the user’s penis.

[0034] Figure 8A illustrates a bottom, side perspective view of another embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device applied to a user’s penis.

[0035] Figure 8B illustrates a top view of the embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device shown in Figure 8A applied to the user’s penis.

[0036] Figure 9 shows an example embodiment of a male-fertility home test kit including an embodiment of the contraception, prophylactic, fluid collection, and / or fluid testing device.

[0037] Figure 10 depicts an example embodiment of a semen collection kit including an embodiment of the contraception, prophylactic, fluid collection, and / or fluid testing device.

[0038] Figure 11 illustrates an example embodiment of a method for sealing an embodiment of a contraception, prophylactic, fluid collection, and / or fluid testing device after the receptacle has received a fluid or substance from a user’s penis.

[0039] Figure 12A illustrates a side view of a contraception, prophylactic, fluid collection, and / or fluid testing device as fluid is initially received.

[0040] Figure 12B illustrates a side view of the contraception, prophylactic, fluid collection, and / or fluid testing device shown in Figure 1 in which a receptacle of the device has expanded to accommodate fluid reception.DETAILED DESCRIPTION OF THE SOME EXAMPLE EMBODIMENTS

[0041] Disclosed herein are embodiments of a contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device (collectively referred to in this disclosure as a contraception device). For example, and without limitation, some embodiments can be directed to contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing purposes (any one of the foregoing purposes, or any combination of the foregoing purposes). In some embodiments, the contraception device can be a disposable, single-use contraception device, semen collection device, or semen testing device.

[0042] Example embodiments of the present disclosure will now be described in some cases with reference to the appended figures representing some example embodiments. Figure 1 shows a top view of an embodiment of a contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device 100. In some embodiments, the contraception device 100 may include a body portion 102, an opening 104 formed in or entirely through the body portion 102, and a receptacle 110 for receiving a fluid (e.g., without limitation, semen) from a user. In some embodiments, the receptacle 110 can be coupled with the body portion 102 or integrally formed with the body portion 102. The receptacle 110 can, in an operable position, extend away from a first surface 102a of the body portion 102.

[0043] In some embodiments, the receptacle 110 can be fluid impermeable and sealed around the opening 104 to prevent any fluid (e.g., semen) from inadvertently passing through the receptacle 110 or leaking through the device 100 between the receptacle 110 and the body portion 102. In some embodiments, the device 100 can have an adhesive material 112 (which can be an adhesive coating) on a bottom surface 102b of the body portion 102.

[0044] In some embodiments, the body portion 102 can have a plurality of first flaps 120a, 120b (also referred to herein as legs or extensions) and / or a plurality of second flaps 130a, 130b (also referred to herein as legs or extensions). In some embodiments, each ofthe plurality of first flaps 120a, 120b and / or the plurality of second flaps 130a, 130b can have a length of from 1 inch, about 1 inch, or less than 1 inch to 2 inches, about 2 inches, or more than 2 inches, or from 0.5 inches or about 0.5 inches to 2 inches or about 2 inches, or of any value, approximate value, or range of values in any of the foregoing ranges. In some embodiments, the device 100 can have a width of 1.5 inches or about 1.5 inches, or 2 inches or about 2 inches, or from 1 inch, about 1 inch, or less than 1 inch to 3 inches, about 3 inches, or more than 3 inches, or of any value, approximate value, or range of values in any of the foregoing ranges.

[0045] In some embodiments, the shape of the device 100 can resemble a bloated “x” or the Greek letter Chi “x”, where the bottom flaps 120a, 120b curve upward toward a shaft 142 of a user’s penis 140 and away from a frenulum 142 of the user’s penis 140. and the top flaps 130a, 130b are straight-edged and flat on the top of a glans penis 146 of the user’s penis 140, pointing toward the groin. The midpoint or main body portion 102, where all four flaps converge, can hold the receptacle 110. with the opening 104 to be centered over the urethral orifice for coverage and sealed collection. Together, the top flaps 130a, 130b can be v-shaped, extending out from the top of the circular midpoint 102 at about 45° angles, while the bottom flaps 120a, 120b together can be rounded and crescent-shaped, extending out at about 28° angles from the base of the midpoint 102. The aforementioned angles can range from about 10° or less than 10° to about 90° or more based on device 100 design and purpose of use. The shape of the midpoint 102 can vary, such as but not limited to, bulging outward spherically, tapering inward rectangularly, or even maintaining the width of the upper and lower flaps in an oval-fashion. Similarly, many alternatives exist for the shape of the receptacle-opening 104, as fluids can be collected through a wide variety of slot types (circular, oval, rectangular, triangular, etc.). The edges of the flaps (120a, 120b 130a, 130b) can be straight-edged, curved, rounded, perforated-edged, or any suitable shape based on purpose of device 100 use and design preferences. Each flap (120a, 120b, 130a, 130b) can have a width of about 0.7mm or less than 0.7mm to 6mm or more than 6mm, in some embodiments.

[0046] The device 100 may have a plurality of different configurations. For example, and without limitation, some may have a ribbed contour or texture, may be slick or have a slick coating, may include a removal tab to grip and peel the device, etc. The device 100 can, in some embodiments, be flexible to conform with the surface of the penis 140.

[0047] Some embodiments of at least the body portion 102 of the device 100 (which may include the flaps 120a, 120b, 130a, 130b) may be ultra- thin. For example and without limitation, some embodiments of at least the body portion 102 (which may include the flaps 120a, 120b, 130a, 130b) can have a thickness of about 0.3 mm, about 0.3 mm, or less than 0.3 mm, or from 0.1 mm, about 0.1 mm, or less than 0.1 mm to 1 mm, about 1 mm, or more than 1 mm, or from 0.2 mm, about 0.2 mm, or less than 0.2 mm to 0.5 mm, about 0.5 mm, or more than 0.5 mm, or of any value, approximate value, or range of values in any of the foregoing ranges.

[0048] In some embodiments, at least the body portion 102 (which may include the flaps 120a, 120b, 130a, 130b) may vary in thickness across different portions of the body portion 102. For example and without limitation, some embodiments of at least the body portion 102 (which may include the flaps 120a, 120b, 130a, 130b) may vary in thickness based on the style and purpose of use of the device 100 - ranging from ultra-thin to 1.2 mm, about 1.2 mm, over 1.2 mm, or any of the values listed above.

[0049] Some embodiments of the body portion 102 (which may include the flaps 120a, 120b, 130a, 130b) may be made from medical-grade silicone, polymers, plastic, hydrocolloid, and / or any other suitable material or combination of materials. In some embodiments, the material used to form at least the body portion 102 can be made from a thin, flexible film. In some embodiments, the material used to form at least the body portion 102 of the device 100 can be a thin, flexible, lightweight, and pliable yet durable or strong enough to support or withstand varying degrees of friction, stretching, and / or moisture.

[0050] The flexibility in the flaps 120a. 120b, 130a. 130b (also referred to herein as legs) can permit the device 100 to be shaped to user preference for a universal-fit. Figures 5A-5D show example configurations of the device 100. Figures 5 A and 5B illustrate the device 100 applied to a user’s penis 140 in a first configuration (e.g.. a snug fit). Figures 5C and 5D illustrate the device 100 applied to the user’s penis 140 in a second configuration (e.g., a wider fit). With reference to Figures 5A and 5B, when used for a snug fit, for example and without limitation, flaps 130a and 130b can be placed facing the penis shaft 142 (e.g., pointing generally toward a proximal end of the penis 140 or toward the groin), and after coverage of the urethral opening with the opening 104 (also referred to herein as a collective cavity opening), flaps 120a and 120b can be wrapped around to layer on the ends of flaps 130a and130b. With reference to Figures 5C and 5D, for a wider fit, flaps 130a and 130b are placed as shown in Figures 5 A and 5B. However, flaps 120a and 120b can be positioned so as to not overlay the other flaps 130a, 130b. In some embodiments, the flaps 120a, 120b can stretch higher to the sides of the glans penis 146. The size, flexibility, and curvature of some embodiments of the device 100 can provide utmost urethral security and efficiency in confining all material to a small portion of the glans penis 146. so that a glans-corona 148. a glans-neck 150, and the frenulum 144 of the user’s penis 140 are left completely exposed, as well as all other erogenous zones of the penis 140. The areas around the frenulum 144 are understood to be the most sensitive and sexually responsive part of the penis 140.

[0051] In some embodiments, the device 100 can be shaped and / or sized to cover only an end portion (e.g., distal end portion) of the user’s penis 140. For example, the device 100 can be shaped and / or sized to cover only a portion of a glans penis 146 and urethra of the user’s penis 140. The device 100 can be shaped and / or sized to not cover any portion of the user’s penis 140 proximal to the glans penis 146, for example, the glans-corona 148, glansneck 150 and / or frenulum 144 portion of the user’s penis 140 which may improve user comfort during sexual activities and incentive usage of the device 100. In some embodiments, the device 100 can at least partially cover the frenulum 144 portion of the user’s penis 140. In some embodiments, the device 100 can be shaped and / or sized to cover only a distal end portion of the user’s penis 140 when the user’s penis 140, in an erect state, is greater than a predetermined length, for example, greater than 2 inches, greater than 3 inches, greater than 4 inches, greater than 5 inches or any value within or bounded by these values.

[0052] Some embodiments of the device 100 can be configured so that the opening 104 (also referred to herein as a collective cavity opening) can be secured by at least a doublelayer ring of material to fasten the attached receptacle 110 to the body portion 102. The receptacle 110 can be multiple layers to aid capillary action (acquisition and distribution), and in some embodiments, made from non-latex or latex plastic, medical-grade polymers, vinyl, polyisoprene, silicone, or other similar material. In some embodiments, the receptacle 110 can have a thickness of 0.07 mm, about 0.07 mm, or less than 0.07 mm, or from 0.05 mm, about 0.05 mm, or less than 0.05 mm to 0.1 mm, about 0.1 mm, or more than 0.1 mm, or any of any value, approximate value, or range of values within the foregoing range, hr some embodiments, the receptacle 110 can be configured to receive, collect, absorb, and / or contain5 ml, about 5 ml, or more than 5 ml of fluids, in some embodiments, without leaking. In some embodiments, the receptacle 110 can be configured to receive, collect, and / or contain from 2 ml, about 2 ml, or less than 2 ml of fluids to 8 ml, about 8 ml, or more than 8 ml of fluids, or any of any value, approximate value, or range of values within the foregoing range.

[0053] Some variations of the receptacle 110 may be sterile, lubricated, contain pH / acidity indicator solution(s), allow ventilation for trapped air to escape, etc. to relate to the purposes of device use. The opening 104 can be sized to be placed over the male urethral opening to seal the area and allow for the contained release of fluids within the receptacle 110. In other embodiments, this opening 104 can have various shapes and sizes to accommodate collection and storage and / or absorption. In the illustrated embodiment, the opening 104 is rectangularly shaped to provide optimal, flat- seal support (no wrinkles) and to ensure a universal fit and no-tear stretchability, as the male urethra varies in length and angulation. In other embodiments, the opening 104 can have an oval shape, a round shape, or other suitable or desired shapes.

[0054] With reference to Figure 2, which shows a second or underside of the device 100, a second or bottom surface of the body portion 102 can, in some embodiments, have an adhesive material 112 or adhesive coating thereon. In some embodiments, the adhesive 112 can be a silicone adhesive film, hydrocolloid, or other similar material. The adhesive 112 can be hypoallergenic, skin-friendly and strong enough to securely hold the device 100 in the desired position, yet gentle enough for pain-free repositioning and residue-free removal.

[0055] Figures 6A-8B show additional embodiments of the device 100, illustrating other shapes of the body portion 102, including the flaps 120a, 120b, 130a, 130b. Any of the embodiments of the device 100 disclosed herein can have any of the features, components, shapes, or other details of any of the components of the embodiments of the devices shown in Figures 5A-8B, in combination with any of the other features, components, shapes, or other details of any of the embodiments of the devices.

[0056] With reference to the embodiment of the device 100 shown in Figures 6A- 6D, the shape of the body portion 102 (including the flaps 120a, 120b, 130a, 130b) can resemble or be similar to a landing-strip with wrap around flaps for security. This design is less compact with wider coverage to pull tight over the urethral opening for an optimal seal and curved long-flaps for further flexibility.

[0057] With reference to Figures 7A-7B, the embodiment of the device 100 shown therein can be used to provide a greater degree of seal security provided horizontally on the glans penis. The flaps of this embodiment can be located to the right and left of the glans penis 146.

[0058] With reference to Figures 8A-8B, the embodiment of the device 100 shown therein is configured to maintain the landing-strip shape with the least material use. The design has a special emphasis on rounded edges as the rounded edges may be less likely to lift during use due to friction or physical contact. Any of the other embodiments of the device 100 disclosed herein can have rounded edges, as shown in Figures 8A-8B or otherwise.

[0059] Figure 9 shows an example embodiment of a male-fertility home test kit 200 including an embodiment of the contraception, prophylactic, fluid collection, fluid absorption, and / or fluid testing device 100. In some embodiments, the test kit 200 can include a bottle 202, an optional device holder 206, a packaged device 210 (which can be any suitable device for semen collection, for example, the device 100). and / or a stirring rod 220. In some embodiments, the bottle 202 can be a dropper bottle 202 which can be made from plastic, or any similar material that allows the bottle 202 to be squeezed for liquid release from a cap 204 connected to the bottle 202, for example, a hole 205 of the cap 204. In some embodiments, the kit 200 can include a dropper and / or pipette which can be used to extract liquid from the bottle 202 and to dispense liquid in a controlled manner.

[0060] In some embodiments, a pH-responsive indicator can be included in the test kit 200. The pH-responsive indicator can undergo a color change when exposed to a specimen (e.g„ without limitation, semen) having a pH outside (e.g.. greater and / or lower than) a target pH range. In some embodiments, the color change can be detectable to the human eye, for example, without the need of additional devices to analyze the color change. In some embodiments, the color change can be analyzed by an optical sensor, imaging module, or a software-based colorimetric reader. In some embodiments, the target pH range can be between 6 and 9 pH, for example, between 6.5 and 8.5 pH, between 6.8 and 8.2 pH, between 7 and 8 pH, between 7.2 and 8 pH, between 7.4 and 7.8 pH or any value or range within or bounded by any of these ranges or values. In some embodiments, the pH-responsive indicator can include stabilizers, fillers, solvents, binder, and / or carriers, for example, water, alcohols, buffers, cellulose substrates, polymer films, and / or chemically inert materials. In someembodiments, the pH-responsive indicator can include one or more pigments, for example, one or more naturally derived pigments such as anthocyanins, flavonoids, and / or other plant- derived chromophores. Such pigments may be extracted from botanical sources, for example, cabbage, berries, hibiscus, and / or other anthocyanin-containing materials. In some embodiments, the pH-responsive indicator can include at least one synthetic pH indicator dye, for example, a sulfonphthalein derivative, azo dye, and / or triphenylmethane dye. In certain embodiments, the pH-responsive indicator includes a blend of two or more pH-responsive dyes to generate a multi-step or gradient-based color change. For example, a specimen (e.g., semen specimen) within a healthy physiological range (e.g., pH approximately 7.2-8.0) can produce a first color response, while specimens outside this range (acidic (pH < 7.0) or alkaline (pH > 8.0)) can produce a second visually distinguishable color response. In some embodiments, the pH-responsive indicator can include a buffering agent or stabilizer configured to maintain consistent chromatic behavior in the presence of proteins, enzymes, or biological material present in semen and / or sperm. The pH-responsive indicator can be provided in any suitable form for exposure to a specimen such as semen, for example, a reagent-coated substrate, a disposable test strip, a dried indicator film, a powder, and / or a pre-mixed liquid solution.

[0061] In some embodiments, the pH-responsive indicator can be provided (e.g., stored) in the bottle 202 in a pre-mixed liquid or solid (e.g., powdered) form. In some embodiments, for example when the pH-responsive indicator is provided in a powdered form, the bottle 202 can indicate a fill-line where the user can remove the cap 204 and add water or any suitable substance that liquifies the powder, appropriately as guided by the line. Once water is added, the cap 204 can be reinstalled by the user, and the bottle 202 can be shaken briefly to mix the contents and to create a pH / acidity indicator solution.

[0062] After placing the device 100 on the penis 140, according to the various configuration options available, the user will ejaculate into the device 100. The device 100 can then be gently removed by lifting the flaps 120a, 120b, 130a, 130b from the penis. The device 100 can then be transferred to a flat surface or the optional device holder 206. If the device holder 206 is present within the kit, it can be made from plastic, polymers, resin, or other similar material. The device holder 206 can be a stable, four-flapped or four-legged structure to resemble a rectangular table. Sizing may vary to accommodate the device, allowing the measurements to range from about 3-4 in x 2.5-3.5 in. The device holder 206 canhave a central opening 230 (also referred to herein as a hole) with a diameter of about 0.25-0.5 in some embodiments. Some embodiments of the device holder 206 can have two divot openings 234 and 236 which can be positioned diagonal each other (for example, proximate diagonal corners of the device holder 206). As the receptacle 110 of the device 100 is lowered into the opening 230, with the bottom surface 102b facing up, two flaps of the device 100 (e.g., diagonally opposed flaps such as flaps 130a. 120b or flaps 130b, 120a) can then be pushed through the divot openings 234 and 236 to secure the device 100 in place on the device holder 206. Once the device 100 is secure on the device holder 206 or on a flat surface, depending on the initial liquidity of the semen, there may be a further waiting period necessary for the semen to liquify (not to surpass about 30 minutes, as this can indicate another fertility marker). After awaiting liquefaction (if necessary), the semen can be stirred with the stirring rod 220. The stirring rod 220 can be about 2 in long, made from polypropylene plastic, or other similar material and is not strictly necessary for kit-use, but can be used to ensure the pH / acidity is reflective of the entire fluid.

[0063] The pH-responsive indicator can be applied to (e.g., dispensed on, exposed to) the semen, for example, directly into the receptacle 110 containing the semen. In some embodiments, the bottle 202 can be lifted, tilted, and / or squeezed to release drops of the pH- responsive indicator solution from the hole 205 in the cap 204 directly into the receptacle 110 containing the semen. Based on an observed color change of the pH-responsive indicator after exposure to the semen, the user can match the result to a color guide and distinguish their fertility result.

[0064] Other configurations for an at-home, male fertility kit can be, but are not limited to, a single device 100 with a receptacle 110 or any suitable device for semen collection, that has an internal lining (e.g., coating or film) that contains the pH-responsive indicator. For example, the internal lining of the device 100 or receptacle 110 can include dried, universal or pH / acidity indicator solution which can be made from phenolphthalein, bromothymol blue, red cabbage or blueberry concentrate, or other similar substances. The pH-responsive indicator can be applied to the device 100 or receptacle 110 using printing, spraying, casting, and / or deposition techniques. In some embodiments, after device 100 placement and ejaculation, the color of the device receptacle 110 will change color to indicate fertility results. Another embodiment of an at-home, male fertility kit can include a single device 100 or any suitabledevice for semen collection and a pH / acidity indicating test strip that can be dipped inside the receptacle 110 after use, safe removal, flat-surface placement, and / or liquefaction. The test strip can change color to indicate fertility results.

[0065] Figure 10 illustrates an embodiment of an example semen collection kit 300. In some embodiments, the kit 300 can include the packaged device 210 (which can be any suitable device for semen collection, for example, the device 100) and a sterile, self-sealing, clear bag 310. The clear bag 310 can be made from medical-grade polyester, polypropylene, waterproof bleached craft paper, or other similar materials that allow durability, tearresistance, impermeability, and maintained sterility. The clear bag 310 can have a folding lip 312 with adhesive tape that seals the contents inside the bag. The exterior of the clear bag 310 can have enough surface area for patient stickers or identification labels to be placed. The sizing of the clear bag 310 can vary based on the device embodiment, and can range from about 4-5.5 in x 4.5-6 in. After device 100 use and gentle removal, the adhesive side of the flaps 120a, 120b, 130a, 130b of the device 100 can be pinched together as shown in Figure 11. This pinch can create a seal that encloses the collected semen within the device 100. The device 100 can be placed inside the clear bag 310 and sealed with the folding lip 312.

[0066] Figures 12A-12B illustrate an additional embodiment of the device 100. Any of the embodiments of the device 100 disclosed herein can have any of the features, components, shapes, or other details of any of the components of the embodiments of the devices shown in Figures 5A-8B and / or Figures 12A-12B, in combination with any of the other features, components, shapes, or other details of any of the embodiments of the devices. With reference to Figures 12A-12B, the embodiment of the device 100 shown therein can include a pretensioned and / or initially flat receptacle 110. The receptacle 110 can be flat in an initial (e.g., pre use, packaged) state (as shown, for example, in FIG. 12A) which may decrease the size of the device 100, improve the visual appearance of the device 100 to encourage use of the device, and / or decrease the risk of the receptacle 110 catching on objects during use. As fluid (e.g., semen) enters the receptacle 110, the receptacle 110 can flex (e.g., expand) to accommodate the fluid (as shown, for example, in FIG. 12B). In some embodiments, the receptacle 110 can include a material that prioritizes absorption of fluid, rather than expanding outward, to maintain its flat state.Additional Embodiments

[0067] Although embodiments of the present disclosure have been illustrated and described herein with reference to preferred embodiments and specific examples thereof, it will be readily apparent to those of ordinary skill in the art that other embodiments and examples may perform similar functions and / or achieve like results. All such equivalent embodiments and examples are within the spirit and scope of the present disclosure, are contemplated thereby, and are intended to be covered by the following claims.

[0068] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0069] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this disclosure belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0070] In describing the disclosure, it will be understood that a number of techniques and steps are disclosed. Each of these has individual benefit and each can also be used in conjunction with one or more, or in some cases all, of the other disclosed techniques. Accordingly, for the sake of clarity, this description will refrain from repeating every possible combination of the individual steps in an unnecessary fashion. Nevertheless, the specification and claims should be read with the understanding that such combinations are entirely within the scope of the inventions disclosed herein and the claims recited herein.

[0071] Disclosed herein are embodiments of a device that can be used as or configured for use as a contraception device, or can be used as or configured for use as a semen collection device. Additionally, in any embodiments disclosed herein, the device can include one or more analysis elements, such as, without limitation, a semen acidity indicator.

[0072] The present disclosure is to be considered as an exemplification of the invention, and is not intended to limit the invention to the specific embodiments illustrated by the figures or description below.

[0073] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.

[0074] Reference throughout the specification to “one example”, “another example”, “an example”, and so forth, means that a particular element (e.g., feature, structure, and / or characteristic) described in connection with the example is included in at least one example described herein, and may or may not be present in other examples. In addition, it is to be understood that the described elements for any example may be combined in any suitable manner in the various examples unless the context clearly dictates otherwise.

[0075] It is to be understood that the ranges provided herein include the stated range and any value or sub-range within the stated range, as if such value or sub-range were explicitly recited. For example, a range from about 2 nm to about 20 nm should be interpreted to include not only the explicitly recited limits of from about 2 nm to about 20 nm, but also to include individual values, such as about 3.5 nm, about 8 nm, about 18.2 nm, etc., and sub-ranges, such as from about 5 nm to about 10 nm, etc. Furthermore, when “about” and / or “substantially” are / is utilized to describe a value, this is meant to encompass minor variations (up to + / - 10%) from the stated value.

[0076] While several examples have been described in detail, it is to be understood that the disclosed examples may be modified. Therefore, the foregoing description is to be considered non-limiting.

[0077] While certain examples have been described, these examples have been presented by way of example only and are not intended to limit the scope of the disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the systems and methods described herein may be made without departing from the spirit of the disclosure. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure.

[0078] Features, materials, characteristics, or groups described in conjunction with a particular aspect, or example are to be understood to be applicable to any other aspect or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The protection is not restricted to the details of any foregoing examples. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0079] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a sub-combination or variation of a sub-combination.

[0080] Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particularorder shown or in sequential order, or that all operations be performed, to achieve desirable results, unless provided otherwise herein. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some examples, the actual steps taken in the processes illustrated and / or disclosed may differ from those shown in the figures. Depending on the example, certain of the steps described above may be removed or others may be added. Furthermore, the features and attributes of the specific examples disclosed above may be combined in different ways to form additional examples, all of which fall within the scope of the present disclosure.

[0081] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular example. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0082] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain examples include, while other examples do not include, certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more examples.

[0083] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require the presence of at least one of X, at least one of Y, and at least one of Z.

[0084] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result.

[0085] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred examples in this section or elsewhere in this specification and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

[0086] Although the foregoing invention has been described in terms of certain preferred embodiments, other embodiments will be apparent to those of ordinary skill in the art. Additionally, other combinations, omissions, substitutions, and modifications will be apparent to the skilled artisan, in view of the disclosure herein. Accordingly, the present invention is not intended to be limited by the recitation of the preferred embodiments but is instead to be defined by reference to the appended claims.

[0087] The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner and unless otherwise indicated refers to the ordinary meaning as would be understood by one of ordinary skill in the art in view of the specification. Furthermore, embodiments may comprise, consist of, consist essentially of, several novel features, no single one of which is solely responsible for its desirable attributes or is believed to be essential to practicing the embodiments herein described. As used herein, the section headings are for organizational purposes only and are not to be construed as limiting the described subject matter in any way. When definitions of terms in incorporated references appear to differ from the definitions provided in the present teachings, the definition provided in the present teachings shall control. It will be appreciated that there is an implied “about” prior to the temperatures, concentrations, times, etc. discussed in the present teachings, such that slight and insubstantial deviations are within the scope of the present teachings herein unless provided otherwise herein.

[0088] Although this disclosure is in the context of certain embodiments and examples, those of ordinary skill in the art will understand that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the embodiments and obvious modifications and equivalents thereof. In addition, while several variations of the embodiments have been shown and described in detail, othermodifications, which are within the scope of this disclosure, will be readily apparent to those of ordinary skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the disclosure. It should be understood that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another in order to form varying modes or embodiments of the disclosure. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above.

Claims

W HAT IS CI Al MED IS:

1. A contraception device for use on a user’s penis, comprising: a main body portion; an opening in the main body portion, the opening passing through the main body portion; and a receptacle coupled to the main body portion around the opening; wherein: the device is configured to be applied to at least a distal end portion of the user’s penis at least around a urethral orifice of the user’s penis so that the opening in the main body portion is generally aligned with the urethral orifice of the user’s penis; and the receptacle is configured to receive a fluid from the user’s penis in a space within the receptacle.

2. The device of Claim 1, wherein the receptacle is a pouch configured to receive semen from the user of the device.

3. The device of Claim 1, wherein the receptacle is a pouch configured to receive and contain all or substantially all semen ejaculated by the user.

4. The device of Claim 1, wherein the device is configured to only cover an end portion of the user’s penis.

5. The device of Claim 1, wherein the device is configured to cover, in an operable state, only a portion of a glans penis and urethra of the user’s penis.

6. The device of Claim 5, wherein the device is configured to not cover any portion of the user’s penis proximal to the glans penis.

7. The device of Claim 5, wherein the device is configured to not cover any portion of a glans-corona, a glans-neck, or a frenulum portion of the user’s penis.

8. The device of Claim 1 , wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 50% of an entire length of the user’s penis that is at least 3 inches long in an erect state.

9. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partiallycover at most a distal most 40% of an entire length of the user’s penis that is at least 3 inches long in an erect state.

10. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 30% of an entire length of the user’s penis that is at least 3 inches long in an erect state.

11. The device of Claim 1 , wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 25% of an entire length of the user’s penis that is at least 3 inches long in an erect state.

12. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 20% of an entire length of the user’s penis that is at least 3 inches long in an erect state.

13. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 15% of an entire length of the user’s penis that is at least 3 inches long in an erect state.

14. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most a distal most 10% of an entire length of the user’s penis that is at least 3 inches long in an erect state.

15. The device of Claim 1 , wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most 25% of an entire surface of the user’s penis that is at least 3 inches long in an erect state.

16. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most 20% of an entire surface of the user’s penis that is at least 3 inches long in an erect state.

17. The device of Claim 1 , wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’ s penis and to only cover or partially cover at most 15% of an entire surface of the user’s penis that is at least 3 inches long in an erect state .

18. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover at most 10% of an entire surface of the user’s penis that is at least 3 inches long in an erect state.

19. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover from 5% to 20% of an entire surface of the user’s penis that is at least 3 inches long in an erect state.

20. The device of Claim 1, wherein the device is configured to cover, in an operable state, at least a portion of a distal end portion of the user’s penis and to only cover or partially cover from 10% to 15% of an entire surface of the user’s penis that is at least 3 inches long in an erect state.

21. The device of Claim 1, comprising one or more flaps extending away from the main body portion, the one or more flaps configured to wrap around a portion of the user’s penis.

22. The device of Claim 1, comprising a first pair of flaps and a second pair of flaps extending away from the main body portion, wherein at least one of the first pair of flaps and the second pair of flaps are configured to wrap around a portion of the user’s penis.

23. The device of Claim 22, wherein the first pair of flaps and the second pair of flaps are configured to wrap around a portion of a distal end portion of the user’s penis.

24. The device of Claim 23, wherein the distal end portion of the user’s penis is a glans penis of the user’s penis.

25. The device of Claim 23, wherein the first pair of flaps curves upward away from a frenulum of the user’s penis toward a shaft of the user’s penis when the device is applied to at least the distal end portion of the user’s penis.

26. The device of any one of Claims 25, wherein the first pair of flaps is crescentshaped.

27. The device of Claim 23, wherein the second pair of flaps extend along a top of a glans penis of the user toward a groin of the user.

28. The device of any one of Claims 27. wherein the second pair of flaps is V- shaped.

29. The device of Claim 22, wherein the device is symmetrically shaped about a centerline of the main body portion extending from a top of the main body portion to a bottom of the main body portion.

30. The device of Claim 1, comprising a semen acidity indicator in communication with the receptacle.

31. The device of Claim 1, comprising a semen acidity indicator solution in the receptacle.

32. The device of Claim 2, wherein the receptacle is configured to expand to receive fluid from the user’ s penis in order to accommodate the fluid.

33. The device of Claim 2, wherein the receptacle is configured to absorb fluid from the user’s penis in order to accommodate the fluid.

34. The device of Claim 1, wherein the main body portion comprises a flexible material.

35. The device of Claim 1, wherein a bottom surface of the main body portion comprises an adhesive material.

36. A method of contraception, comprising: adhering a cover over a distal end of a user’s penis so that cover covers a distal end of the user’s penis but not a glans-corona of the user’s penis, so that a receptacle of the cover is positioned over a urethral orifice of the user’s penis, and so that no portion of the user’s penis proximal to the glans-corona of the user’s penis is covered by the cover when the cover is in an operable position on the user’s penis.

37. The method of Claim 36, wherein no portion of a glans-corona, a glans-neck, or a frenulum portion of the user’s penis is covered by the cover when the cover is in an operable position on the user’s penis.

38. A male-fertility test kit comprising: the contraception device according to Claim 1 ; anda pH-responsive indicator configured to undergo a color change when exposed to semen having a pH outside a target pH range.

39. The kit of Claim 38, wherein the pH-responsive indicator is configured to produce a first color response for semen within the target pH range and a second color response for semen outside the target pH range.

40. The kit of Claim 39, wherein the target pH range is between 6 pH and 9 pH.

41. The kit of Claim 39, wherein the target pH range is between 6.5 pH and 7.5 pH.

42. The kit of Claim 39, wherein the target pH range is between 7 pH and 8 pH.

43. The kit of Claim 39, further comprising a storage receptacle configured to store the pH-responsive indicator and to dispense the pH-responsive indicator in response to user interaction.

44. The kit of Claim 43, wherein the storage receptacle is a dropper bottle comprising a cap, the cap comprising a hole for dispensing the pH-responsive indicator.

45. The kit of Claim 39, further comprising a device holder configured to secure the contraception device, the device holder comprising an opening configured to receive the receptacle of the contraception device.

46. The kit of Claim 45, wherein the device holder comprises a plurality of secondary openings configured to receive a plurality of flaps of the contraception device to anchor the contraception device to the device holder.

47. The kit of Claim 39, wherein the pH-responsive indicator comprises a premixed liquid solution or a powder.

48. The kit of Claim 39, wherein the pH-responsive indicator includes a buffering agent or stabilizer configured to maintain consistent chromatic behavior in the presence of proteins, enzymes, or biological material present in semen.

49. The kit of Claim 39, wherein the pH-responsive indicator comprises a plant- derived chromophore.

50. The kit of Claim 39, wherein the pH-responsive indicator comprises a synthetic pH indicator dye.

51. A method of testing semen fertility using the contraception device of Claim 1, comprising: applying the device to a distal portion of a user’s penis;collecting semen in the receptacle of the device; removing the device from the user’s penis; and dispensing a pH-responsive indicator configured to undergo a color change when exposed to semen having a pH outside a target pH range.

52. The method of Claim 51, further comprising matching an observed color change of the pH-responsive indicator to a color guide to distinguish a fertility result.

53. The method of any one of Claims 51, further comprising securing the device to a device holder by inserting the receptacle of the device into an opening of the device holder.

54. The method of Claim 53, further comprising securing the device to the device holder by inserting at least one flap of the device into at least one secondary opening of the device holder.

55. A male-fertility test kit comprising: a contraception device configured to be applied to a user’s penis to receive semen from the user’s penis within a receptacle of the contraception device; and a pH-responsive indicator configured to undergo a color change when exposed to semen having a pH outside a target pH range.

56. The kit of Claim 55, wherein the pH-responsive indicator is configured to produce a first color response for semen within the target pH range and a second color response for semen outside the target pH range.

57. The kit of Claim 56, wherein the target pH range is between 6 pH and 9 pH.

58. The kit of Claim 56, wherein the target pH range is between 6.5 pH and 7.5 pH.

59. The kit of Claim 56, wherein the target pH range is between 7 pH and 8 pH.

60. The kit of Claim 56, further comprising a storage receptacle configured to store the pH-responsive indicator and to dispense the pH-responsive indicator in response to user interaction.

61. The kit of Claim 60, wherein the storage receptacle is a dropper bottle comprising a cap, the cap comprising a hole for dispensing the pH-responsive indicator.

62. The kit of Claim 56, further comprising a device holder configured to secure the contraception device, the device holder comprising an opening configured to receive the receptacle of the contraception device.

63. The kit of Claim 62, wherein the device holder comprises a plurality of secondary openings configured to receive a plurality of flaps of the contraception device to anchor the contraception device to the device holder.

64. The kit of Claim 56, wherein the pH-responsive indicator comprises a premixed liquid solution or a powder.

65. The kit of Claim 56, wherein the pH-responsive indicator includes a buffering agent or stabilizer configured to maintain consistent chromatic behavior in the presence of proteins, enzymes, or biological material present in semen.

66. The kit of Claim 56, wherein the pH-responsive indicator comprises a plant- derived chromophore.

67. The kit of Claim 56. wherein the pH-responsive indicator comprises a synthetic pH indicator dye.

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