Patent Application
20050256483
Some embodiments of the present invention relate to a vaginal insertion device, and in particular to a disposable vaginal insertion device.
A typical vagina is a relatively long and tube-like structure that extends from the cervix (i.e., outer end of the uterus) down to the labia minora. A vagina will normally emit secretions from glands in the vaginal lining and the cervical canal of the uterus. As an example, mucous is developed in the cervical canal of the uterus during the phase of the menstrual cycle where the endometrium thickens and glands in the endometrium secrete mucous.
Vaginal secretions are typically clean but occasionally debris in the form of blood or seminal fluid can accumulate within the vagina. When debris accumulates within the vagina it may be beneficial to treat the vagina with fragrances, medications, germicides and/or deodorants (among other items).
One method of treating the vagina includes using douching products. Some conventional douching products include a nozzle that is attached to a bottle filled with a cleaning solution. The cleaning solution is forced through the nozzle into the vagina under pressure. One drawback with such douching products is that bacteria can be forced up into the cervix when too much pressure is applied to force the cleaning solution up into the vagina. In addition, these types of products can rinse out healthy, normal flora (lactobacillus) along with unwanted materials, such as semen, discharges and bacteria.
Other conventional douching products are applied to the vagina as films that are later discharged from the body. One drawback with film-based douching products is that they are difficult to insert up into the vagina. Another drawback is that the film is discharged from the vagina over time such that a pantiliner is often required for a couple of days after the film is applied to prevent staining in undergarments.
There are some vaginal cleaning products that are designed to provide mechanical cleaning of the vagina without using free flowing fluid. These types of devices are typically inserted into the vagina and mechanically manipulated in order in clean the vagina.
One drawback with using such devices is that they are difficult to properly insert into the vagina because it is difficult to determine how far the device is being inserted into the vagina. Another drawback with using such devices is that it is difficult to tell just how much the device is being manipulated within the vagina because most of the device is hidden from view within the vagina during cleaning.
There is a need for a vaginal insertion device that is able to mechanically clean inside a vagina and/or apply a material inside the vagina. The vaginal insertion device should be able to be inserted into the vagina without irritating the vagina. The vaginal insertion device should also provide one indicator as to how far the device is inserted into the vagina and/or another indicator as to how much the insertion device is being rotated within the vagina.
In response to the drawbacks described above with respect to conventional vaginal douching products and cleaning devices, a disposable vaginal insertion device has been invented.
One aspect of the invention relates to a disposable vaginal insertion device. The disposable device includes a housing having a first end and a second end and a core that is positioned within the housing. The core includes a handle and a swab that is secured to the handle. The core is axially movable within the housing between a first position where the swab is at least partially within the housing and a stop on the handle is outside the housing, and a second position where the swab is extended through the second end of the housing and the stop on the handle engages the housing to prevent further insertion of the handle into the housing. In some embodiments, the swab is positioned entirely within the housing when the core is in the first position and is positioned entirely outside the housing when the core is in the second position. The core may also be able to rotate within the housing such that the handle of the core periodically engages the housing to provide an indication as to how far the core is rotating within the housing.
Another aspect of the invention relates to another disposable vaginal insertion device. The disposable device includes a housing having a first end and a second end, and a core that is positioned within the housing. The core includes a handle and a swab that is secured to the handle. The core is able to rotate within the housing such that the handle of the core periodically engages the housing to provide an indication as to how far the core is rotating within the housing. In some embodiments, the core and the housing emit a sound when the handle periodically engages the housing. The handle may engage the housing one or more times per revolution of the core relative to the housing. In some embodiments, the core may be axially movable between a first position where the swab is at least partially within the housing and a stop on the handle is outside the housing, and a second position where the swab is extended through the second end of the housing and the stop on the handle engages the housing to prevent further insertion of the handle into the housing.
Another aspect of the invention relates to a method of engaging a vagina. The method includes inserting a disposable vaginal insertion device into a vagina. The disposable device includes a housing having a first end and a second end and a core that is positioned within the housing. The core includes a handle and a swab that is secured to the handle. The core is inserted into the vagina when the core is in a first position where the swab is at least partially within the housing and a stop on the handle is outside the housing. The method further includes axially moving the core to a second position where the swab is extended through a second end of the housing further into the vagina until the stop on the handle engages the housing to prevent further insertion of the swab into the vagina. In some embodiments, the method may further include rotating the handle of the core to clean the vagina with the swab. Rotating the handle to clean the vagina with the swab may include engaging the handle with the housing to provide an indication as to how far the core is rotating within the housing.
Still another aspect of the invention relates to another method of engaging a vagina. The method includes inserting a disposable vaginal insertion device into a vagina. The disposable device includes a housing having a first end and a second end and a core that is positioned within the housing. The core includes a handle and a swab that is secured to the handle. The method further includes rotating the handle relative to the housing to clean the vagina with the swab and to periodically engage the handle with the housing. Periodically engaging the handle with the housing provides an indication as to how far the core is rotating within the housing. In some embodiments, inserting the disposable device into the vagina may include inserting the disposable device into the vagina when the core is in a first position where the swab is at least partially within the housing and a stop on the handle is outside the housing, and then axially moving the core to a second position where the swab is extended from the second end of the housing further into the vagina until the stop on the handle engages the housing to prevent further insertion of the swab into the vagina. In addition, rotating the handle of the core to periodically engage the handle with the housing may include generating a sound by periodically engaging the handle with the housing, and/or periodically applying a force that overcomes resistance generated by engaging the handle with the housing.
The above-mentioned and other features will become more apparent and better understood by reference to the following description of the invention taken in conjunction with the accompanying drawings.
The disposable vaginal insertion device of the present invention may provide an efficient, healthy and low-cost way to clean inside a vagina without using a douching product. The disposable device may also provide an effective way to apply a material inside a vagina.
As used herein, “disposable device” includes a device that is disposed of after use and is not intended for reuse. The disposable device described herein may be especially useful to an individual that needs to mechanically clean (or apply materials to) their vagina in a variety of situations.
As used herein, the term “securing” means permanently bonding. Any securing, or bonding, of the handle 21 to the swab 24 may occur at any time during the fabrication of the disposable device 10. Some of the example methods that may be used to bond the swab 24 to the handle 21 include adhesive bonding, thermal bonding and ultrasonic bonding (among others).
The core 20 is axially movable within the housing 12 between a first position (
The swab 24 may be constructed of any material that is suitable for insertion into a vagina. Some example materials include cotton, rayon, wood pulp and polymeric substances such as nonwoven fabrics, foam sponges and thermoplastics.
The swab 24 may be designed with any type of surface that enhances the disposable device's cleaning properties. In some embodiments, the surface of the swab 24 may be textured to facilitate removal of residue and film from the vagina.
In some embodiments, the swab 24 may be composed of a nonwoven fabric. As used herein, “nonwoven fabric” refers to a web or fabric (made partly or wholly of non-cellulose material) that includes individual fibers which are interlaid (randomly or in a pattern) in a knitted fabric. The nonwoven webs may be formed many processes, including meltblowing, spunbonding and bonded carded. The nonwoven fabrics that are used in the swab 24 may be produced from polymers such as polyethylene or polypropylene.
The swab 24 may also be formed of a nonwoven fabric that is made of an array of interbonded thermoplastic fibers. The fibers may be formed from a wide variety of thermoplastic materials. Some example thermoplastic materials include polyolefins (e.g., polyethylene, polypropylene), polystyrene and polyamides (e.g., nylon). In addition, thermoplastic polymers that are elastomeric may also be used as fibers. Some example elastomeric materials include polyurethanes and block copolymers. It should be noted that blends of any of the foregoing materials may be used to form the fibers.
The fibers may also include additives (e.g., wax, pigments, stabilizers and fillers) that are inserted as the fibers are fabricated to achieve one or more desired properties within the fibers. Some example additives include compatible surfactants that are added to the polymers to make the surface of the fibers more wettable and thereby improve the ability of the swab 24 to attract unwanted debris within the vagina. It should be noted that the amount of surfactant that is added to the fibers can be adjusted to control the surface wetting of the fabric that is formed from the fibers. Some example surfactants that may be added to the fibers include sodium dioctyl sulfosuccinate and alkyl phenoxy ethanol (among others).
In some embodiments, the swab 24 may include a cover material (not shown) that is placed on the swab 24 to prevent fiber sloughing. In addition, some cover materials may improve the wettablilty of the swab 24. There also cover materials that may provide stain-masking. In addition, some cover materials may be capable of capturing and/or storing substances within the cover material itself, or trapping the substances within the inner portion of the swab 24.
As examples, the cover material may store and/or capture debris, cleansers, lubricants, spermicidal agents and medications (among other materials) before, or after, using the disposable device 10. Some example cover materials include spunbound, spunlace, bonded carded web and apertured film materials. In one example embodiment, the cover material is an apertured film that is formed of a polyolefin which may or may not be combined with a nonwoven fabric.
When a nonwoven fabric is used as the material for the swab 20, the basis weight of the nonwoven fabric may vary depending on the properties that are desired within the swab 20. As an example the basis weight for the nonwoven fabric may be as low as 10 grams per square meter and as high as 300 grams per square meter.
In the example embodiment illustrated in
The housing 12 helps to protect the swab 24 from contamination when the core 20 is in the first position. In the example embodiments illustrated in
The housing 12 may be made from a material that is non-toxic, low cost and hygienic. Some example materials that may be used for housing 12 include polyethylene and polypropylene (among other materials). In some embodiments, the housing 12 may be made from a combination of materials.
The width (i.e., outer diameter) of the housing 12 may vary depending on the functional properties that are desired of the disposable device 10. In some embodiments, the housing may be small enough to make it easy for a user to insert the disposable device 10 into the vagina while being wide enough to give the housing 12 sufficient space to store a large enough swab 24 for cleaning inside the vagina and/or applying a material to the vagina. As an example, the width of the housing 12 may be between 25 mm and 60 mm.
The wall thickness of the housing 12 should be large enough to provide sufficient rigidity to the disposable device 10 during vaginal insertion. As an example the wall thickness may be between 2 mm and 10 mm. In addition, the length of he housing 12 may be between 60 mm and 150 mm. The relative lengths of the housing 12 and the swab 24 may vary depending on the desired properties of the disposable device 10.
In some embodiments, the second end 14 of the housing 12 includes resilient members 16 that at least partially close the second end 14 of the housing 12. As the core 20 is moved from the first position to the second position, the resilient members 16 are forced apart by the swab 24 (see
The core 20 may also be able to rotate within the housing 12 such that the handle 21 periodically engages the housing 12 as the core 20 rotates within the housing 12. When the handle 21 periodically engages the housing 12 during rotation, a user of the disposable device 10 is provided with an indication as to how far the core 20 is rotating within the housing 12.
In the example illustrated embodiment, the handle 21 engages the housing 12 during rotation when the core 20 is in the second position. As shown in
Although the stop 23 is shown with two members 27 and the housing 12 is shown with two detents 17, it should be noted that any number of members 27 and detents 17 may be included on the stop 23 and the housing 12. As an example, the stop 23 may include one section and the housing 12 may include one detent such each time the member engages the detent the core 20 has been rotated one full revolution.
In the example embodiment illustrated in
The handle 21 may be a variety shapes and sizes. In addition, the cross-section of the handle 21 may take a variety of forms (e.g., circle, square, rectangle and polygon) depending on the properties that are desired within the disposable device 10.
The handle 21 may be made from any material that is suitable for use in a disposable vaginal insertion device 10. The handle 21 should be made from a material that is non-toxic, low cost and hygienic. Some example materials that may be used for handle 21 include paper, cardboard, polyethylene and polypropylene (among other materials). In some embodiments, the handle 21 may be made from a combination of materials.
It should be noted that handle 21 may be solid or hollow. When the handle 21 is hollow, the wall thickness of the handle 21 should be large enough to provide sufficient rigidity to the disposable device 10.
In some embodiments, the handle 21 may have a length that is between 40 mm and 250 mm. The relative lengths of the swab 24, housing 12 and handle 21 may vary depending on the desired properties of the disposable device 10. The handle 21 and the swab 24 may be sized to keep the handle 21 far enough outside the vagina when the core 20 is in the second position to allow a user to adequately manipulate the swab 24 via the handle 21. In addition, the handle 21 and the swab 20 may be sized to be short enough to allow a user to generate sufficient pressure on the vagina with the swab 24 via the handle 21.
The width (i.e., outer diameter) of the handle 21 may be small enough to make it easy for a user to insert the disposable device into the vagina while being wide enough to give the handle 21 sufficient rigidity to properly clean inside the vagina and/or apply a material to the vagina. As an example, the width of the handle 21 may be between 3 mm and 50 mm depending in part on the material that used for the handle 21.
Many other embodiments are contemplated for the handle and/or the stop.
The swab 64 may be similar to the swab 24 shown in
The core 60 may be able to rotate within the housing 52 such that the handle 61 of the core 60 periodically engages the housing 52 as the core 60 rotates within the housing 52. The periodic engagement between the handle 61 and the housing 52 indicates to a user how far the core 60 is rotating within the housing 52.
The handle 61 on the core 60 may engage the housing 52 in any number of configurations.
In some embodiments, the core 60 and the housing 52 emit a sound (e.g., a click) when the handle 61 periodically engages the housing 52 during rotation of the handle 61 within the housing 52. It should be noted that although the members 63 are shown in
As the core 60 rotates, the members 63 and/or detents 65 on the handle 61 engage the projections 55 and/or detents 56 on the housing 52 to provide an indication to the user that the core 20 has rotated at least one-half of a revolution relative to the housing 52. One-half of a revolution is indicated because the members and/or detents are on opposing sides of the handle 61 and the housing 52. In other embodiments, the handle 61 may include one member or one detent and the housing 52 may include one projection or one detent such each time the handle 61 engages the housing 52, the core 60 has been rotated one full revolution within the housing 52.
In the example embodiment illustrated in
The relative lengths and widths of the swab 64, housing 52 and handle 61 may vary depending on the desired properties of the disposable device. The cylindrical tube should have a wall thickness that is large enough to provide sufficient rigidity to the disposable device 50 during vaginal insertion. In addition, the materials and mechanical properties for the handle 61 may be similar in many respects to the materials and mechanical properties that were described above with regard to
In some embodiments, the core 60 is axially movable within the housing 52 between a first position (
In the example embodiment illustrated in
In any of the disposable devices described or reference herein, a cleanser (not shown) may be applied to the swab of the disposable device. The term “cleanser” refers to any paste, gel, powder, oil, liquid or any other appropriate medium that may be used in vaginal cleansing. Some example cleansers include surfactants such as water-soluble polymers, polysorbates, glycerins, glycol-based surfactants and/or silicone-based surfactants. It should be noted that the swab may also include other materials, such as water, salts, vinegars, humectants, scouring powders, thickening agents and aromas (among others).
The cleanser may be applied to the swab 20 such that the cleanser is moist to the touch, or the cleanser may be dry and then activated upon contact with the vaginal tissue. The cleanser should not kill significant amounts of lactobacillus while removing unwanted debris during mechanically cleaning of the vagina. In addition, the cleanser should not contain ingredients that might lead to dry vaginal mucosal tissue.
In some embodiments, the cleanser may include a moisturizer that helps to maintain a normal hydration level after mechanical cleaning. The cleanser may also contain preservatives and other ingredients that do not disrupt the normal flora of the vaginal vault (e.g., sorbic acid, citric acid, methyl paraben and natural preservatives such as grapefruit extract).
The cleanser may be applied to the elongated swab 20 by various means including spray-coating, dipping, doning, impregnating, electro-spinning coating and inkjet printing (among others). In addition, the cleanser may be applied to the elongated swab 20 at any point in time. As examples, the cleanser may be applied to the elongated swab 20 just prior to using the disposable device 10 to mechanically clean a vagina, or the cleanser may be “pre-applied” to the elongated swab 20. As used herein, “pre-applied” refers to applying the cleanser to the elongated swab 20 during a manufacturing process of the disposable device 10 and/or the elongated swab 20. In addition, “pre-applied” also refers to applying the cleanser to the elongated swab 20 before the sale of disposable device 10.
It should be noted that other materials besides cleansers may be applied to the elongated swab 20 such that the disposable device 10 can be used to apply materials to the vagina. Although any appropriate material may be added to the elongated swab 20, some example materials include lubricants and other inactive or active ingredients (e.g., a spermicidal agent or a medication). Another example material may be a motility enabler that facilitates sperm motility. Any of the materials that may be applied to the elongated swab 20 may be in any form (e.g., liquid, powder and paste).
An example method of engaging a vagina will now be described with reference to
As shown in
The method may further include rotating the handle 21 to clean inside the vagina 100 with the swab 24 and/or to apply a material (e.g., a lubricant) to the vagina with the swab 24. It should be noted that rotating the handle 21 may include engaging the handle 21 with the housing 12 to provide an indication as to how far the core 20 is rotating within the housing 12. In addition, engaging the handle 21 with the housing 12 may include engaging the handle 21 with the housing 12 when the core 20 is in the second position.
Another example method of engaging a vagina will now be described with reference to
In some embodiments, inserting the disposable vaginal insertion device 50 into the vagina 100 may include inserting the disposable device 50 into the vagina 100 when the core 60 is in a first position where the swab 64 is at least partially within the housing 52 and a stop 70 on the handle 61 is outside the housing 52 (see
Rotating the handle 61 of the core 60 to periodically engage the handle 61 with the housing 52 may include (i) generating a sound when the handle 61 periodically engages the housing 52; (ii) periodically applying a force that overcomes resistance generated by engaging the handle 61 with the housing 52; and/or (iii) engaging the handle 61 with the housing 52 one or more times per revolution of the core 60 relative to the housing 52.
Any of the disposable devices shown and/or described herein may used in any of the methods of engaging a vagina described herein. While the invention has been described in detail with respect to specific embodiments, it will be appreciated that there are variations of, and equivalents to these embodiments. Accordingly, the scope of the present invention should be determined by the appended claims and any equivalents thereto.
