HK1229220B - Device and method for inserting lubricating capsule - Google Patents

Description

Device and method for inserting a lubricating capsule

Background Art

Sexual intercourse is a beneficial part of a healthy and active adult life. In the case of vaginal intercourse, female physiology is particularly suited to facilitate this behavior through various changes that occur in the female reproductive system, including: lengthening of the vaginal canal, contraction of the muscles surrounding the vagina, secretions from several glands at the back of the vagina, secretions directly from the inner vaginal wall (sweat), and secretions from the Bartholin glands at the vaginal opening, which secrete relatively small amounts of fluid (one or two drops of fluid when a woman is sexually aroused). These tiny droplets of fluid used for lubrication were once thought to be important for vaginal lubrication, but research from Masters and Johnson suggests that vaginal lubrication primarily originates from deep within the vagina. The (Bartholin gland) fluid can slightly moisten the labial opening of the vagina, making contact with this sensitive area more comfortable for the woman. A large number of commercially available lubricants are known for external application, but it is clear that, for various reasons (some of which are discussed here), the naturally occurring small amounts of lubricant from the labial opening are in many cases insufficient to provide adequate lubrication, while the vast majority of secretions originate from deep within the vagina. All of these changes occur in healthy women and contribute to a pleasurable experience for everyone involved.

Although women's bodies can produce these changes during sexual intercourse, many women complain that insufficient secretions can cause vaginal discomfort and pain during or after sexual intercourse. Except that there is no frequent vulvovaginal inflammation infection and the dryness and malnutrition of these organs caused by postmenopausal estrogen reduction, one of the reasons for vaginal pain during and after sexual intercourse is that the vagina is inserted before the woman is fully awakened. Considering that the first reaction of female genitalia to sexual stimulation is vaginal lubrication, if just inserting when the woman is not properly awakened, therefore when not producing necessary physiological vaginal lubrication, some symptoms of vulvovaginal discomfort may occur. In addition, even when fully awakened, many women also can suffer from lubrication inadequately due to various reasons (some reasons have been mentioned). Insufficient lubrication may also cause a certain degree of discomfort and pain in the male penis.

Transudation is the process that causes vaginal lubrication. When a woman becomes sexually aroused, blood flows into the area surrounding the vaginal walls in a process called vasocongestion. The increased blood pressure causes water to seep from the spaces between cells. This water originates from the vaginal lining, initially appearing as tiny droplets. Eventually, the fluid builds up enough to moisten the entire vaginal lining. During the stimulation phase, blood flow to the vagina increases, which in turn pushes fluid into the vaginal cavity. This lubrication process allows for comfortable and repeated penetration of the penis during sexual intercourse.

Natural cycle hormonal changes, stress, and the use of combined or progestin-only hormonal contraceptives (if applicable) affect the amount and consistency of vaginal lubrication during normal daily activities and during sexual arousal. Many medications women take to treat other conditions can adversely affect vaginal lubrication. These medications include antihistamines, anticholinergics, antihypertensives, and most psychotropics (particularly SSRIs and benzodiazepines). Women of all ages have various reasons to use lubricants or moisturizers to enhance their natural vaginal secretions and facilitate comfort before, during, and after sexual activity. In addition, repeated penetration during intercourse can cause lubricant to dry out before the activity is complete. Many men, like women, also prefer additional lubrication during sexual activity to enhance sexual pleasure for themselves and their partners.

A problem with traditional methods and products for enhancing the natural lubrication system of the human body is that lubricant is applied at the entrance of the vagina (or anus). This is unsatisfactory for several reasons. The natural lubrication system of the female body secretes lubricant from deep within the body cavity, and the act of sexual intercourse causes the lubricant to spread along the wall of the vagina. If lubricant is applied to the entrance of the penis or vagina, most of the lubricant will be scraped off and rubbed off by the insertion of the penis, which greatly weakens the effectiveness of the lubricant. Existing products for enhancing the natural lubrication system of women are applied at or near the vaginal opening and cannot reproduce the human body design (body ' s design) that is well lubricated from the body cavity. The present invention is intended to overcome this shortcoming.

Summary of the Invention

The present invention is a lubrication system and device in which a soft capsule (commonly known as a "gel cap") containing a lubricant inside can be punctured and inserted into a body cavity where the capsule can leech or expel the lubricant into the body cavity. Continuous lubricant delivery can occur in situ as a result of muscle contraction surrounding the capsule and/or contact by an object such as a penis. Preferably, the capsule filled with a lubricant material, a drug, or some beneficial substance, or a combination thereof, is made of a bioabsorbable material so that the capsule can be safely absorbed in the body upon depletion in a manner similar to how a vitamin E capsule is absorbed in the body after releasing its contents via oral delivery. The present invention includes a delivery system that punctures the capsule and then delivers the capsule into the body cavity.

For example, a lubricant capsule delivered into the vagina and provided with a small slit or puncture opening will subsequently exude lubricant as a byproduct of sexual intercourse due to contraction of the muscles surrounding the vaginal wall, compression caused by the impact of the penis, and continuous seepage due to the tiny puncture opening created before insertion. The lubricant is then pressed outward along the walls of the vagina (or anal cavity) by the movement of the penis and the shape of the penis head, which has a larger diameter than the cavity, so the penis head pushes the lubricant along the vaginal walls. Thus, throughout the entire action, lubricant is continuously released from the capsule inside the vagina or body cavity, which is similar to the body's own lubrication system.

To deliver lubricant capsules, a two-piece applicator is provided. The applicator comprises an outer tube of elongated cylindrical configuration having an open, plate-like bottom; and a plug-like tube that fits within the outer tube and is capable of sliding along its length. The plug may also include an outer plate-like bottom that is slightly larger than the bottom at the end of the outer tube, so that a fully inserted inner tube "stops" at a predetermined maximum distance. The applicator may include a spring that applies a force that returns the applicator to a relaxed, or undepressed, position. Similar to a mechanical pencil, the inner plug can extend against the force of the spring, and then, when released, returns the plug to its original position. In this manner, a user can controllably eject the capsule from a position where the capsule is restrained at the distal end, with the spring retracting the plug ensuring that the needle is safely retracted from the capsule upon ejection.

The inner tube has a cavity or cup at its distal end for capturing (or retaining) the capsule. The receiving cup contains a needle, multiple tiny needles, a tiny blade, or one or more other objects capable of creating a puncture hole in the capsule. The puncture device is securely positioned within the concave cup to avoid contact with any body tissue. The larger base of the tubular inner plug creates a "stop" point and prevents the inner plug from exposing the needle (or other puncture device) and contacting any body tissue, thereby preventing any tissue damage. The capsule is then manually positioned within the cup and pushed onto the needle (or other puncture device) with gentle pressure. This creates a rupture sufficient to allow the contained material to leak or seep out once the capsule is securely inserted into the vagina. Once the plug is fully inserted into the body cavity, the capsule is safely released and securely positioned within the cavity. The applicator may be equipped with a spring-loaded or push-release mechanism within the plug to eject the capsule from the receiving cup once the applicator is inserted into the body cavity. That is, the applicator is inserted into, for example, the vagina with the capsule positioned distally, within the receiving cup. The plug is then actuated, pushing the capsule away from the receiving cup, allowing the capsule to be inserted into the back of the vagina, away from the vaginal opening, with the puncture hole of the capsule oriented toward the opening of the body cavity. The punctured capsule will slowly leak its contents into the vagina. When the head of the penis (or other object) comes into contact with the capsule, a small amount of additional lubricant will be released through the tiny opening to continuously lubricate the vaginal wall. In this way, sexual intercourse can be made more pleasurable and enjoyable, eliminating the dryness and discomfort of those who need or desire additional lubrication. The capsule itself, which is a biocompatible soluble material (similar to a vitamin E gel cap), will safely "melt" or "dissolve" in the body cavity, providing additional lubricating material and being absorbed without consequence. If there is any remaining after the sexual intercourse is over, it can be easily removed manually if desired.

It is envisioned that the capsule piercing concept will achieve additional beneficial purposes, including assisting individuals who cannot or prefer not to swallow capsules. The present invention will enable individuals to administer the contents of a capsule by simply piercing the capsule, lightly chewing the pierced capsule a few times, and then discarding the capsule. While devices currently exist for crushing or cutting tablets, many medications, vitamins, nutritional supplements, and the like are contained within liquid-filled "capsules." The simple piercing device described in this invention makes it possible to access the contents of a capsule without swallowing it.

It should be noted that while the present invention is described herein with respect to the application of lubricants, it is understood that the present invention also has other uses, including the delivery of medications, vitamins, nutrients, and other materials that may need to be inserted into body cavities from time to time. Accordingly, the present invention is intended to encompass all such applications and uses, and is not limited to those described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Hereinafter, the present invention will be described in detail in accordance with preferred embodiments with reference to the following drawings attached to this application.

FIG1 is a top perspective view of a two-piece applicator of the present invention;

FIG2 is an optional puncturing device for puncturing the capsule;

FIG3A is a top perspective exploded view of an alternative embodiment for puncturing a capsule;

FIG3B is a top perspective view of an alternative embodiment of FIG3A ;

FIG4A is a cross-sectional view of the embodiment of FIG3A taken along line 4A-4A;

FIG4B is a cross-sectional view of the embodiment of FIG3A in a closed position; and

4C is a cross-sectional view of the embodiment of FIG. 3A showing the contents of the balloon being expelled by the device.

DETAILED DESCRIPTION

The present invention is an applicator that safely delivers a bioabsorbable lubricating balloon into a body cavity. Once inserted into the body cavity, the balloon can dispense lubricant directly to the wall of the body cavity from the inside, thereby applying a thin layer of lubricant that can protect the lining of the body cavity from wear, tear, or excessive friction that can cause discomfort.

FIG1 illustrates a first preferred embodiment of the present invention, which features a two-piece, elongated cylindrical applicator 10 having a first, cylindrical outer sheath 12 and a cylindrical inner plug 14 slidably received within the outer sheath 12. The cylindrical outer sheath 12 is formed at a distal end 18 with a hemispherical receiving receptacle or cup 22 capable of holding a lubricant capsule 20. The plug 14 is equipped at its distal end with a piercing element 16, such as a needle, blade, fork, or knife edge. In alternative embodiments, there may be multiple piercing elements 16, such as multiple needles or knife edges. The piercing elements 16 are positioned within the receiving cup 22 at a depth such that, once the capsule 20 is loaded into the receiving cup 22, it is impacted by the piercing elements 16 to the point of rupture. The plug 14, which is slidable within the sheath 12, extends to the receiving cup at its distal end, such that the capsule can be "pushed" out of the receiving cup by the plug 14 when the plug is fully actuated (i.e., depressed). The plug may also include a spring at the base or end to assist in ejecting the capsule. The plug 14 may include a narrow portion at the end to help push the capsule out of the receiving cup 22. The plug 14 may be biased by the spring 21 into an inactive state. The user then depresses the plug 14 against the force of the spring 21 to eject the capsule 20, which provides greater control over the process and ensures that the plug 14 will separate from the capsule when it is withdrawn and returned to its original position.

To use the applicator 10, the user removes the preferably single-use applicator from its sterile packaging and places the lubricated (or other) capsule 20 into the receiving cup 22 until the puncturing element 16 ruptures or punctures the capsule. The applicator 10 is then inserted into a body cavity, such as the vagina or rectum. Once the applicator 10 is fully inserted into the body cavity, the plug 14 is actuated to push the capsule 20 from the receiving cup 22 into the body cavity. The plug 14 is designed so that no portion of the plug extends from the sheath 12, thereby preventing tissue damage during insertion or removal. The applicator 10 is then withdrawn from the body cavity, leaving the punctured bioabsorbable capsule 20 within the body cavity. The perforation in the capsule 20 begins to leak its contents (lubricant or other delivery fluid) into the body cavity (in situ). Although the capsule can be manually retrieved after the procedure if desired, it is preferably absorbed by the body. This method of lubrication has the advantage that the lubricant will not be wiped off during the insertion process, which is the case with methods and devices that apply lubrication externally.

FIG2 illustrates an alternative embodiment in which the puncturing tool 30 is a separate device from the applicator 10. Here, a cylindrical hollow tube 32 is mounted to a base 34 and includes a needle or puncturing element 36 fixed at a depth spaced from the upper opening 38. The capsule 20 can be inserted directly into the cylindrical hollow tube 32 with a concave bottom surface until the capsule 20 is punctured, after which the capsule can be transferred to the applicator 10 or the contents can be manually emptied. This embodiment has the advantage of omitting the puncturing element from the applicator inserted into the body. However, in the first embodiment, it should be understood that the puncturing element 16 must not extend beyond the outer sheath 12 under any circumstances to prevent contact between the puncturing element 16 and tissue within the body cavity. The second embodiment can be readily utilized for the purpose of orally administering the contents of the capsule. The sequence can include puncturing the capsule, chewing the capsule, discarding the capsule shell, and orally administering the contents.

The capsule 20 can be a variety of soft capsules of various sizes, such as soft capsules with a consistency similar to that of vitamin E soft capsules. When placed in a body cavity, pressure on the outer surface from surrounding tissue and muscle as a result of sexual intercourse can cause the capsule to leak lubricant through the puncture hole. The rate of diffusion depends on the amount of pressure and the size of the opening, so it is necessary to carefully create an acceptable puncture hole that allows sufficient lubricant to diffuse out without releasing all of the lubricant immediately. In this way, a time-release lubrication system is disclosed that allows for continuous lubrication throughout the entire process.

The term "capsule" is used herein to generally refer to any device used to store a lubricant or medication. This would include a bag, a sponge-like material impregnated with a transport fluid, a gel, a balloon, or any other breakable container that can be cut, punctured, punctured, or otherwise opened to release the fluid. Furthermore, as described above, the puncturing device can be a needle, a spike, a blade, a barb, a knife edge, or the like, so long as it can successfully create an opening in the capsule to release its contents.

One advantage of the present invention is that it is suitable for hygienic delivery of lubricant without the introduction of germs or bacteria. Each applicator 10 can be sold in a sealed package for single use only to prevent any unwanted organisms, debris or contaminants from being introduced into the human body. The body cavity can be the vagina, anus, urinary organs or any other body cavity that can beneficially receive fluid. In addition, the use of puncturing elements 16, 36 allows for immediate initiation of sexual intercourse, while other prior art systems require the medication or lubricating patch to dissolve before use, which may take more than half an hour. The present invention allows for immediate release of lubricant and allows for delayed release of lubricant during procedures lasting more than thirty minutes. Once completed, there is no need to retrieve the capsule, but rather it can be safely dissolved in the body and absorbed without consequence.

Figures 3A-3B and 4A-4C illustrate another embodiment for puncturing a capsule. A box 40 having a pair of sidewalls 42, a bottom surface 44, and a top surface 45 is formed with an inner wall 46 that divides the inner chamber of the box 40 into two smaller chambers. The top surface 45 includes a pivoting flap 47 that is hinged centrally in front of the dividing wall 46 and can slide downward on tracks or hinges within the box. A block 48 sized to fit snugly within the interior of the box 40 is formed with a recess 50 sized to capture and receive a breakable capsule 20 on a first side of the block 48. The recess 50 includes a needle 52 that can be used to puncture the capsule 20 when the capsule 20 enters the recess 50. To help control the capsule during the puncturing process, the user can squeeze the top surface 45 of the box 40 at the flap 47 to capture and secure the capsule 20 within the box. That is, using finger pressure applied in the direction of arrow 49, plate 47 can squeeze capsule 20 downward as block 48 is inserted into box 40 (sliding in and out like a matchbox sliding in and out of its outer structure). Inner wall 46 prevents the capsule from being pushed to the rear of box 40, ensuring proper engagement of the capsule with needle 52. When block 48 is removed, as shown in FIG4C , box 40 will contain capsule 20 punctured by needle 52 and retained at the open end of box 40. By applying greater finger pressure in the direction of arrow 49, the user can squeeze the contents 51 of the capsule out of the capsule without ever touching the capsule 20 due to the clamping movement of pivoting plate 47. In this way, the user can quickly and efficiently empty a liquid or gel-filled capsule without touching the needle or the capsule. This device can be used to open the capsule for patients who are unable to swallow tablets, etc., allowing the contents of the capsule to be discharged onto a spoon, tongue, etc.

The embodiments just described and depicted in the accompanying drawings are not intended to limit the present invention, but rather are exemplary modes and uses of the present invention. It should be understood that various modifications and alternative uses can be conceived, and as will be understood by those skilled in the art, the present invention is intended to include all such modifications and alternative uses.

Claims (3)

1. An applicator for insertion and lubrication, the applicator being used for insertion into and lubrication of a body cavity, the applicator comprising: The elongated, hollow, and cylindrical outer sheath includes a receiving cup at its end for receiving the lubricating sac. A plug, which is slidably received within the elongated, hollow, and cylindrical outer sheath, the plug including at its end a piercing element adapted to extend into the receiving cup; The lubricating bladder, filled with liquid, is arranged in the receiving cup; The puncturing element is used to puncture the lubricating sac located in the receiving cup before the applicator is inserted into the body cavity, and the plug can be pressed down once the applicator is inserted into the body cavity to inject the punctured lubricating sac into the body cavity, after which the applicator is withdrawn, and the punctured lubricating sac leaks the liquid inside the lubricating sac into the body cavity. 2. The applicator for insertion and lubrication according to claim 1, characterized in that the applicator further comprises a spring component for returning the plug to its original position. 3. The applicator for insertion and lubrication according to claim 1, characterized in that the applicator includes a plurality of puncture elements at the end of the plug.