Patent Application
20200323699
In modern medicine, a primary goal in the administration of medication is to deliver such medication to the body of the individual by the most direct route to the target of the medication. In other words, delivery of a drug to treat a medical ailment of a patient should be highly targeted to reach and treat the ailment for which the medication is intended in the least amount of time, with the least amount of communication of the medication administered to areas of the body not requiring it. Such accurate targeting is especially desired where other parts of the body may react adversely to the medication, or where a circuitous route through the body may dilute the medication.
In the case of vaginal disorders which may occur monthly such as cramps or which may be caused by viruses, yeast, or other pathogens, it is desirable that a treating medication be delivered directly to the vaginal cavity of the person. Further, in some cases, it is desirable that the medication delivery be prolonged so as to have time to communicate to regions of the vaginal canal or cervix without problems from body fluids draining from the delivery area preventing medication delivery.
Multiple delivery systems have been employed over recent decades to provide such targeted and prolonged delivery. However, because of issues with drug delivery via the vaginal canal, suppositories and foams which provide carriers for the medication frequently fail or are rendered less than effective due to fluid flow and drainage from the canal. Tampon related devices have been tried, but the prior art is configured in such a manner that the released medication can actually be absorbed by the tampon rather than delivered to the body of the user.
The forgoing prior art examples concerning vaginal drug delivery are intended to be illustrative and not exclusive, and they do not imply any limitations on the invention described and claimed herein. Various other limitations of the related art are known or will become apparent to those skilled in the art upon a reading and understanding of the specification below and the accompanying drawings.
The device and method herein provide a solution to the targeted delivery of medications to targeted areas within or in direct communication with the vagina. Further, the system herein is employable for targeted delivery of medication, over a prolonged time period, through direct communication through the tissue of the vaginal canal to treat ailments directly, and to also communicate medications and the like to the bloodstream and surrounding areas.
The disclosed system relates to a device for vaginal drug delivery. More particularly, the system relates to a tampon engaged or engageable device, having a dissolvable elongated housing which is adapted with an axial cavity sized to surround a tampon, and having a fixed or removably engaged dissolvable capsule located at a distal end of the housing. So positioned, the device delivers medications such as prescription and non prescription drugs, neuroceuticals, and supplements and the like, directly to the vaginal tract which is especially useful in treating ailments in the same region by such a direct communication of the medication thereto.
The exemplary device herein provides an easy to employ vaginal drug delivery system, through the employment of a medication infused polymeric capsule and/or cylindrical housing which is adapted for employment in combination with a tampon, or provided in an assembled form therewith. The product is thus employable to communicate medications directly to the patient through the vaginal canal, where it can directly communicate and treat a related ailment, prior to the tampon becoming active. So configured, the device can be employed for delivery of analgesics, antifungal medications, newer medications such as CBD and THC, and any other medication where communication thereof in a targeted fashion through the vaginal canal is desired.
Because tampons are widely employed throughout the world, the provision of the exemplary device in configurations adapted for engagement to a tampon, or in a combination with a tampon, help insure widespread use. This is because widespread familiarity with the use and employment of tampons does not require most users to change their normal habits or learn new skills. Further, the device and method herein are configured to disburse the medication to the vaginal tract before the tampon is placed in active and absorbing communication therewith.
In one mode, the device may be provided as a capsule adapted for engagement to, or provided in combination with, a cylindrical housing having an axial cavity housing a tampon. The capsule may be a dissolvable polymer such as PCL or other material, which is impregnated with, and/or has a cavity therein, which holds the medications to be delivered to the targeted area via the vaginal canal. The cylindrical housing may also be formed of such dissolvable material which is preferably configured to dissolve more slowly than the material forming the capsule. This intentional delay for a calculated duration, allows dissolving of the capsule with concurrent communication of the medication therein to the body, before the cylindrical housing dissolves and exposes the absorbent tampon. It thus prevents absorption of the medication by the tampon.
In a similar mode of the device herein, the capsule and cylindrical housing can be formed as a unitary structure. In this mode the capsule may dissolve at a concurrent rate as the dissolution of the housing, or it could dissolve more rapidly thereby positioning the cylindrical housing surrounding the tampon to inhibit absorption of the medication.
In another mode of the device herein, the capsule may be configured in the same dissolvable manner so as to provide ongoing delivery of medication locally. However, the dissolvable capsule may be adapted for a removable engagement to a conventional plastic or paper housing which surrounds a conventional tampon. In use, the capsule, in this configuration, will disengage and dissolve over time. Such will allow for the capsules bearing the medication required for the patient to be dispensed from a pharmacy, and engaged to conventional tampons whereupon they would release on insertion and dissolve over time.
With respect to the above description, before explaining at least one preferred embodiment of the herein disclosed vaginal drug delivery system invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangement of the components in the following description or illustrated in the drawings. The invention herein described and shown is capable of other embodiments and of being practiced and carried out in various other ways by those skilled in the art upon reading this disclosure. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for designing of other vaginal drug delivery devices and for carrying out the several purposes of the present disclosed device. It is important, therefore, that the claims be regarded as including such equivalent construction and methodology insofar as they do not depart from the spirit and scope of the present invention.
As used in the claims to describe the various inventive aspects and embodiments, “comprising” means including, but not limited to, whatever follows the word “comprising”. Thus, use of the term “comprising” indicates that the listed elements are required or mandatory, but that other elements are optional and may or may not be present. By “consisting of” is meant including, and limited to, whatever follows the phrase “consisting of”. Thus, the phrase “consisting of” indicates that the listed elements are required or mandatory, and that no other elements may be present. By “consisting essentially of” is meant including any elements listed after the phrase, and limited to other elements that do not interfere with or contribute to the activity or action specified in the disclosure for the listed elements. Thus, the phrase “consisting essentially of” indicates that the listed elements are required or mandatory, but that other elements are optional and may or may not be present depending upon whether or not they affect the activity or action of the listed elements. The term “substantially” when employed herein, means plus or minus twenty percent unless otherwise designated in range.
It is an object of the present disclosure to provide an easily employed vaginal drug delivery system and method therefor.
It is an additional object of this disclosure to provide a dissolvable drug delivery device which is adapted for engagement around a tampon or provided in combination with a tampon, to provide for easy and widespread use.
These and other objects, features, and advantages of the present vaginal drug delivery device and method in the system herein, as well as the advantages thereof over existing prior art, which will become apparent from the description to follow, are accomplished by the improvements described in this specification and hereinafter described in the following detailed description which fully discloses the invention, but should not be considered as placing limitations thereon in any fashion.
The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate some, but not the only or exclusive examples of embodiments and/or features of the disclosed system employing the device and method herein. It is intended that the embodiments and figures disclosed herein are to be considered illustrative of the invention herein, rather than limiting in any fashion.
In the drawings:
In this description, the directional prepositions of up, upwardly, down, downwardly, front, back, top, upper, bottom, lower, left, right and other such terms refer to the device as it is oriented and appears in the drawings and are used for convenience only and such are not intended to be limiting or to imply that the device has to be used or positioned in any particular orientation. Additionally, where the word substantially is used, such is intended to be plus or minus twenty percent, unless otherwise defined upon such use.
Now referring to drawings in
An axial cavity 16 is positioned within the sidewall forming the cylindrical housing 14 and has an opening 18 communicating with the axial cavity 16 at a proximal end. The opening 18 allows for the insertion of a tampon 20 into the axial cavity 16.
In the mode of the device 10 of
In a preferred mode to help prevent absorption of the fluid bearing the medication delivered by the dissolving capsule 12, the wall forming the cylindrical housing 14 is formed of a material mix calculated to dissolve more slowly than the capsule 12. In this fashion the medication from the capsule 12 is communicated to the vaginal canal before the tampon 20 is exposed to fluid flow therein. As noted, this prevents absorption of the medication by the tampons.
The capsule 12 may be formed in a solid solution of dissolvable polymer or other material which is impregnated with the medication, or it may be formed with a capsule cavity 22 which is surrounded by walls forming the capsule 12. Where the capsule cavity 22 is provided, dissolvable medication may be positioned within the capsule cavity 22 which will disperse into the vaginal canal once an opening forms in the wall of the capsule 12 as it dissolves.
As depicted in
Additionally, capsules 12 having a secondary supply of one or a plurality of medications may be provided where the capsule 12 is formed with a capsule cavity 22. This secondary medication supply may be pre-positioned within the capsule cavity 22, or for example, may be positioned therein by a medical professional using, for example, a hypodermic needle which is temporarily communicated through the wall of the capsule 12 surrounding the capsule cavity 22.
Finally, the removably engageable dissolving capsule 12 may be configured with mating connectors 24 or adhesive, which is configured to engage on or with the distal end of the cylindrical housing 14. Such, for example, might be pins or hooks which engage with the internally housed tampon 20, or might be projections which engage with connectors positioned on an endwall 26 at the distal end of the cylindrical housing 14. Where adhesive provides the mating connectors 24, such may engage the endwall 26 or might engage the internal surface of the axial cavity 16 if no endwall 26 is present.
Finally,
It should be noted that any of the different depicted and described configurations and components of the device 10 employed in the system herein for vaginal drug delivery, can be employed with any other configuration or component shown and described as part of the device herein. Additionally, while the present invention has been described herein with reference to particular embodiments thereof and/or steps in the method of production or use, a latitude of modifications, various changes and substitutions are intended in the foregoing disclosure, and it will be appreciated that in some instance some features, or configurations, of the invention could be employed without a corresponding use of other features without departing from the scope of the invention as set forth in the following claims. All such changes, alternations and modifications as would occur to those skilled in the art are considered to be within the scope of this invention as broadly defined in the appended claims.
The current application claims priority to U.S. provisional patent application Ser. No. 62/832,724, filed Apr. 11, 2019, the entire disclosure of which is incorporated herein.
| Number | Date | Country | |
|---|---|---|---|
| 62832724 | Apr 2019 | US |
