CA2223614A1

CA2223614A1 - Urethral cap

Info

Publication number: CA2223614A1
Application number: CA002223614A
Authority: CA
Inventors: Sergei Bogojavlensky; Robert Schlesinger; Robert W. Schaefer
Original assignee: NEBL Inc
Current assignee: Individual
Priority date: 1995-06-07
Filing date: 1996-06-06
Publication date: 1996-12-19
Also published as: AU5953996A; DE69624705D1; CA2223963A1; EP0831751B1; WO1996039991A1; AU5987096A; JPH11506671A; BR9609404A; DE69624705T2; US5908379A; EP0831751A1; WO1996039990A1; JPH11509111A; EP0831750A1; ATE227108T1

Abstract

A urethral cap is provided for alleviating urinary incontinence when attached to the body of the user. The cap has at least a partially deformable cap body with a hand gripping portion and a body contacting encircling surface. The body defines a chamber so as to allow for a vacuum seal when applied to the body so that there is an atmospheric air pressure seal between the urethral cap and the body to prevent urinary flow beyond the urethral cap.

Description

W096~9991 ' PCTrUS96/09032 URFTRRAT CAP

R~ck~ o~ ~ of th~ Inv~nt~on Urinary ;n~on~;n~n~e, such as ~L.c88 inCOn~in~n~e, in fe~ is a subs~nt;~l problem th~o~Jl~o~Jt the world. A variety of ~h~ni - have been ~gg~sted for use to alleviate the condition which can be a ~oci~l as well as me~ic~l problem to those afflicted with the problem Many suggested -'ic~l devices to alleviate urinary ;n~ontin~n~e in f~ 1~ require the use of int~-n~l co~L~ ~nts such as ~th~t~-s, b~llson~, pessary or the like which pass into the urethra and are posit;sn~ within the body in use. Such internal ~~ L~o~nts can be a source of irritation to the body and in some cases can result in infection or other unw~nte~ body reactions Moreover, such devices as are known can be ~p~n~ive and/or inco--ve..ient to use and transport for use Sl-mm~y of th~ Tnventi~n It is an object o~ this invent;sn to provide a urethral cap Çor alleviating urinary ;n~nt;n~n~e such as stress inCont;n~n~e in f -1~5 which cap is ;n~Yr~n~ive to provide, is simple to apply and le...~ve and which does not create a high risk of body infection Still another object o~ this inv~ntion is to provide a urethral cap in accordance with the prece~;ng cap which utilizes atmospheric pressure to ~-int~in the cap in position on the body of a user.
Still another object o~ the present invention is to provide W096~9991 PCTrUS~6/03032 a urethral cap in accordance with the prec~;n~ objects which can incorporate a se~l;n~ material which can be a lubricant or adhesive to aid att~' t to the body.
Still another object of the present inv~n~; ~n is to provide a method of alleviating urinary inCont;n~n~y in a user by applying a urethral cap block;n~ the outer orifice of the urethra at the meatus, and ~tjl;<~;ns an air pressure difference to m~;nt~;n the cap on the body of a user.
Still another object of this invention is to provide a method in accordance with the prece~;ng method wherein an adhesive is used in conjunction with holding the cap on the body.
Still another object of this invention is to provide a method in accordance with the pr~c~;ng objects which can be rapidly carried out by a user and provides safe and certain protection against ;nCont;n~n~y in women.
According to the invention, a urethral cap ~or alleviating urinary incont;n~ncy when attached to the body of a user has a resilient at least partially deformable cap body with a hand gripping portion. The body defines a chamber sized to allow for reciprocal resilient deformation of the cap body to provide a vacuum therein to hold the urethral cap on the body of a user. A
lower portion of the cham~er acts to contact the meatus to constrict the meatus when the cap is applied to the body. The cap body further de~ines an encircling ~lange having a body contacting surface to act as a sealing surface with the body of a user.
Preferably, this encircling flange has a diameter of about 3 centimeters and preferably in the range of about 2.4 to 3.3 c~nt;m~ters to allow proper positioning on the ~emale body at the =

WO9~9991 PCT~S~6~3~2 orifice of the urethra. Preferahly, the cap is formed o~ a resilient body compatible rubbery material such as sil;c~ne rubber and can be sterilized and ~k~ged under sterile conditions.
According to the method of this inv~t; ~n, urinary ;nCo~t;n~n~ in women is alleviated and u.,~ ted urinary ~low prevented by applying a urethral cap having an ;nt~rn~l ~hr ' ?r, over a urethra outer body orifice of the user The cap defines a hand gripping portion and an encircling flange having a body contact surface which aids in sealing the urethral cap to the body of the user. Air pressure is employed below atmospheric air pressure to maintain the cap in place and CG~lyLess the meatus.
The urethral cap is .~...~ved to allow voiding when desired and can be reapplied.
lt is a ~eature of this invention that the ~h~n~e of in~ection and internal irritation to a user is re~ since no nts o~ the cap pass into or through the urethra of the user and the cap is external to the pody. The cap can be made o~
st~n~d nonirritating body compatible materials such as silicone rubbers and the like. In use, the air pressure diiference between the chamber o~ the cap and the atmosphere holds the cap in place This positioning can be ~nh~nC~ by use o~ an adhesive 5~1 ;n~ material if desired, and/or is preferably ~nh~n~e~ by the use of a non-adhesive s~1;ng material. The se~l;ng material can he preapplied. The cap allows for collection of a small ~m~llnt of urine in an internal ~h~mh~ as well as ease o~ ~ vdl to allow urinary ~low and ease of replac~ ~. In ordinary use, the meatus is closed ~y the urethral cap and no urine leakage occurs to the ~h~mh~ or outside o~ the body. The cap can be made WO96~9991 PCT~S96/09032 relatively inexpensively of in~r~ncive materials in proper sizing as re~uired. A small number o~ sizes can be used to fit the vast majority o~ users.

Rrie~ Descr;~tion of th~ Dr~wings The above and other objects, ~eatures and advantages of the present invention will be better understood ~rom the ~ollowing description when read in con~unction with the ~c~ _ ~ing drawings, in which:
FIG. 1 is a top view o~ a preferred embo~;m~n~ o~ the urethral cap in accordance with this invention;
FIG. 2 is a cross-sectional view thereo~ taken through line 2-2 o~ FIG. l;
FIG. 3 is a bottom view thereof;
FIG. 4 is a cross-sect;on~l view through a section o~ the ~large o~ a cap in accordance with FIG. 1 having a plurality of sealing layers applied thereto;
FIG. 5 is a semi-diagrammatic top plan view of the urethral cap of FIG. 1 in place on the body o~ the user; and FIG. 6 is a diay~ tic cross-sectional view as through line 2-2 of FIG. 1 o~ the urethral cap when in place on the body o~ the user.

Detailed DescriDtion A pre~erred embo~im~nt of a urethral cap or incont;n~ce device is illustrated at 10 as best shown in FIGS. 1-3. The cap comprises a body 11 de~ining an inner chamber 12 with an outer ~lange 13 and an intermediate ~rustoconical portion 14.
The body o~ the urethral cap in the pre~erred embo~im~nt o~

~.

W09~i39991 PCT~S96tO9032 FIG. l has a cylindrical wall l5 around a central axis 40 of the cap, with a rounded outer end wall 16, a finger gripping ledge 17 and a body cont~cting encircling surface 18 are provided.
The urethral cap is preferably integrally formed as by c~-~V~t;on~l molding but can be made by dipping, spraying or other techniques. The material of the integral cap is preferably an FDA a~l~v~d medical grade silicone rubber. However, elastomeric materials such as medical grade silicone rubber sold by Dow Corning Co., elastomeric ureth~n~s, polyvinyl chlorides, narural and other rubbery material or synthetic polymeric materials can be used. In some cases, the body need not be integrally ~ormed but can be formed of rigid materials which can be polymeric or metallic. In these cases, at least a portion of the body opening into the interior chamber 12 is formed of a resilient material which can be elastically and reciprocally moved by the fingers ~rom the at rest position as shown in FIG. 2 to a c~ ylessed or reduced ~mh~r position and then allowed to ~p~n~ to the at rest position. This is necessary in order to provide at least a partial vacuum in the chamber to seal the cap to the body by an air pressure differ~nt;~l between the air within the chamber and the atmospheric air pressure as will be described.
The side wall thi~kn~s of the cap is arranged so that side wall lS has a thicker section and is more resistant to collapse or de~ormation by atmospheric pressure than is the flange portion 13 which tapers ~rom the wall 15. The thickness of wall l5 can be, ~or example, l.75 -;ll; ter thick with a pre~erred range of l.5 to 2.5 m; llim~ter, with a flange 13 thickness I of, ~or example, 0.75 millimeter in the preferred embodiment and a CA 022236l4 l997-l2-04 WO96~9991 PCT~US~6/0~03~

preferred range of 0.5 to 1.5 .;ll; -t~- and can be formed of an FDA a~ ~v~d m~i C~l grade silicone rubber. This difference in wall thic~ness prevents collapse on itself of the devic~ in use, yet, allows for ~.~v. - t o~ the flange towards the body in use.
As best seen in the cross ~ct;on o~ FIG. 6, the flange 13 can be deformed towards or closely cnnt~t the body at the planar area of the body sul~u ~;ng the ~tll~ or urethra orifice. A
portion of orifice of the urethra indicated at 20 can be drawn into c~nt~ct with the flange 13 and the frusto~nic~l portion 14 which acts to close the meatus in order to ~-;nt~;n position of the cap, to form a good seal with the body at flange 13 and to close the meatus to urine flow.
In use, the meatus is preferably closed by a gentle compression of the area around the meatus to form a closure .aint~i n~ in position by an air pressure difference. Any structure that provides a closure of the meatus to urine flow, yet allows com~ort in use and ease of reuse, can provide the advantages of this invention. These advantages can be obt~;n~
by the device 10 acting solely ext~rn~lly of the body without any part thereof entering the body of a user.
The end wall 16 o_ the cap pre~erably provides a hand gripping wall 17 although any conf;5uration which allows ~or finger gripping o~ the cap to allow positioning on the body and ~e..-~vdl therefrom by the fingers of the user is acceptable.
Thus, although the cap is shown as a cylindrical side wall, rounded end wall top with frustoconical section 14 and encircling flange 13, the shape can vary greatly. The section 14 is important to provide the closure o~ the meatus. Generally, the angle of the interim wall sur~ace 141 with the surface 18 is CA 022236l4 l997-l2-04 WO96~99~1 PCTrUS96/09032 o~tuse to ~nh~n~e closure o~ the meatus. This internal wall surface 141 is a lower portion of rh~h~ 12 and closes the meatus by pressure thereo~.
It is preferred that the flange 13 pro~ide a body ~ont~r~
surface 18 forming a c~nt;nllol~ ring about the op~n;ng or ,--tllc of the urethra of the body. II~ ver, other portions of the cap can be square, round, nhl~ng, bulbous, or of any shape desired.
Flat, rather than rolln~ end wall 16 can be used. In all cases, sufficient interior space is provided at the inner rh- ' -r 12 which extends to the tip of the flange, to provide ~or forming an at least partial vacuum in the chamber by finger compression, and allowing resilient rebound to the posit;on; ng as in FIG. 6.
The ~;m~n~ions of the urethral cap can vary greatly.
~ owever, conC;stent with normal anatomy of females in the ~nited States, it is preferred that the diameter A be in the range o~ 2.3 to 3.4 c~nt; ~t~s and more pre~erably 2.4 to 3.3 centimeters with 3 c~nti~~ters being used in the preferred embodiment. Where the flange 13 is oval or o~ other encircling shapes such as square, oblong, triangular or the like, the m~Y; flange width corr~cpon~;n~ to the diameter of flange 13 between the labia is about 3.4 centimeters. Diameter B is preferably in the range of l c~nt;~cter to 2.5 centimeters with 1.5 mi11; ?ters being preferred. The height D of the device is pre~erably 1 to 3 c~nti ters and in the preferred embo~;m~nt 2 c~nt;-eters. This height can vary greatly but by maint~in;ng the de~ice a~-~imately 1 to 3 c~nt;m~ters in height, the device can be worn without discomfort, positioned easily and is resistant to dislodging by garments worn by the user.
Distance E can be, for example, 1 3 5 centimeters in the preferred ~mho~; t with the ~h~ diameter o~ ~h~h~ 12 shown at F being 7~ ters in the pre~erred ~mhO~;~Dnt.
Distance H which A~f;n~ in part the interior ~h- ' ?r can be 5.25 ~;11; -ters in the preferred _ ;~~nt but again can ~ary greatly The most important A; - Q; ~n~ relate to the range of 2.3 to 3.4 C~nt; ~t~s in outer diameter of flange 13 for proper posit;on;n~ in the body and preferably the height is no more than about 3 c~nt; m~ters to allow ease o~ use and reuse In the pre~erred ~mho~ nt~ Silastic HS-30, ~n~lf~ctured by Dow-~orn;n~ Corp of Midland, Michigan, is used as the elastomeric material for the integral cap lQ The Silastic HS-30 preferably has a Durometer Shore A o~ 32, tensile strength psi (Mpa) 1325(9 13) and an elongation of 1020% The Silastic silicone rubber can be cured with convent;on~l peroxide curing agents such as Lupersol l0l, a product of Penwalt Corp oi Bu~alo, ~ew York Co..ve..~ional colorants can be used to add color as, ~or example, organic and inorganic pigments In use, a sealant material which can be an adhesive but need not be an adhesive, is applied to the body contacting sur~ace 18 The purpose o~ this material shown in FIG 4 at 3 0 is to provide an air and liquid seal between the skin o~ the body and the ~lange I~ the seal is adhesive, it not only seals against air and liquid pressure leakage, but can also act to hold the device in contact with the body However, it is preferred not to use solely an adhesive as the body adhering portion since this could be irritating to the body i~ su~icient adhesive is used to provide proper protection on the other hand, when substantially no adhesive properties are used in the s~l; ng material, su~~icient protection against urinary leakage is provided by the WO96/39991 PCTAJS9~/090~2 ; nron~ inence device lO of this invention.
The cap preferably is symmetrical about a central axis 40 shown in FIGS. 2 and 3 although it need not be symmetrical in all embo~; m~n t ~ .
The s~ material 30 can be known adhesives which are nonirritating to the body and can be used in ron~ct with the body over a period of time. Such adhesives include the water soluble paste FT~nFNT~ or ~ON~ 1V~N-1 an adhesive proA~ by Block Drug of Jersey City, New Jersey. However, s~1 ;n~
materials such as conventional lubricants including petrolatum or petroleum jelly such as Vaseline0 can be used without adhesive properties. The sealing material such as petroleum jelly compensates for irregularities in the skin or cap s~l ;ng surface flange and thus provides for protection ~;n~t air and urine leakage in use of the device when the device is applied to the ~ody.
The s~l ;n~ material 30 can be applied by the user using a Q-tip applicator or the fingertip to rub the vaseline or adhesive over the body se~li n~ surface just prior to use. In some cases, the lubricant or adhesive can be prepositi~n~ on the device with a cover or release strip 3l applied thereover to prevent sticking or removal of the sealant or adhesive prior to application. In some cases, a plurality of sealant and cover strips can be used as suggested in FIG. 4 at 32 and 33. Thus, in the first application, the lower strip 33 is ~ ved exposing an underlyina surface 32 o~ adhesive or lubricant s~l ;ng material for a first application to the body. This can be done where the se~l~nt directly cont~cting the flange directly is an adhesive and, thus, the product is main~ine~ on the body. After first removal, the CA 022236l4 1997-12-04 .
WO96/39991 PCTrUS~6/0~32 -1~
second cover strip 31 can be ~ d to expose the underlying adhesive 30 ~or a second application. Any nllmh~ o~ protecti~e strips and se~l~nt layers can be used as desired. In the preferred ~mho~ nt, the se~l~nt material is ~rplie~ just prior to use by the user as when ~aseline petroleum jelly is used.
FIGS. 5 and 6 dia~ t;C~lly show pl~c~ ~ t on the body.
In FIG. 5, the labia 41 are diagrammatically illustrated with the urethral op~n; n~ or meatus 42 being shown with the ~lange 13 positioned thereover. In FIG. 6, the cap 10 is shown in position with the skin o~ the body about the meatus pulled into direct contact with the body contacting sur~ace 18 o~ the ~lange and the underside o~ the ~rustoconical portion 14. This closes the urethral ori~ice and the positioning o~ the skin below the ~lange acts to aid in centering and maint~ining the cap in position on the body as well as to prevent urine out~low. S; m; 1 ~ly, because the ~lange 13 is positioned to lie substantially just within the labia 41 at a planar area around the meatus, positioning is m~;nt~in~ and this spacing aids in locating and placing the urethral cap in position.
In the method o~ applying the urethral cap o~ this invention, the cap is de~ormed inwardly by the ~ingers o~ the user and then applied to the ori~ice o~ the urethra and allowed to ~xr~n~ to its original shape as shown in FIG. 2 This creates a vacuum within the inner chamber 12 causing outside atmospheric pressure to push against the ~lange 13 and ~rustoconical portion 14 and maintain the urethral cap in good s~l ;ng engagement with the body. The skin or tissue i ~ tely surrol-n~; ng the meatus is compressed by the air pressure di~erence and a seal is ~ormed with the cap lO at the sur~ace 141. The sealing material CA 022236l4 l997-l2-04 W096/3999i PCTrUS~G~032 preapplied to the body contacting surface 18 aids in ~-;nt~;n the seal. The pressure differ~nt;~l between the ;n~ of the cap and the atmosphere can vary greatly- This ~p~n~ in part on atmospheric conditions as well as how much depression is applied to the rh~mh~r be~ore it resiliently returns to its normal position shown in FIG. 2. In some cases, the full reposit;~n;ng of FIG. 2 is not achieved after cG~ ession of the side wall in application, but in all cases, some chamber vacuum or partial vacuum r~m~;n~ inside the cap. The interior rh ~cr 12 can act as a reservoir if there is some leakage while the cap is in place, although this does not normally occur.
As previously noted, the skirt size is such that it aids in yositioning the skirt in proper position over the urethral ori'ice and also maint~;n;ng the cap in place. The ~inger grip is important for placement particularly in older patients. The ~inger grip can be simply the cylindrical outer surface o~
chamber 12.
The differential in air pressu,re between the inside o~ the cap and the atmosphere is dif~icult to determine. In many cases, the air pressure di~erential may be as little as 1 psi or can be 2-5 psi or 6-lO psi or more. Pre~erably, the pressure is applied by the depression o~ the cap and the ~r~n~ion thereof towards its original shape since the walls are resiliently deformable This can result in di~~erent amounts of pressure when even the same cap is used dep~n~;n~ on how it is applied and how much depression occurs surprisingly, it has been ~ound that even with small caps ~ollowing the method o~ this invention, sufficient air pressure di~ference is obt~;n~ to maintain the cap in position and avoid urine ~low.

WO96~9991 PCT~US96/09032 Thus, a user can alleviate urinary ; n~ont; n~n~ such as stress incont;n~n~e by applying the cap over the urethral orifice using the labia Sp~;n~ to help position the cap. Prior-to c~nt~ct with the body, the cap is resiliently depressed at the hand gripping portion and the encircling ~lange is b~yhL into contact with the skin 3 ~ ; ng the orifice op~n; ng . The body cont~cting portion of the flange has been previously treated with petroleum jelly or an adhesive as previously aescribed. Slight pressure on the skin and r~le~ of the pressure deforming the cap causes a suction within the cap and provides the air pressure difference on the outside of the flange and frustoconical portion l~ that ~;nt~in~ the cap in place on the body and closes the meatus as shown in Fig. 6. The cap can be easily ~-,.oved to ~llow voiding when desired. In some cases, the cap can merely be pulled off the skin although a slight depression of the finger g-ipping portion is desired to alleviate the pressure dif~erence first. The device is com~ortable in use, can be easily applied by a majority o~ patients and has been ~ound to prevent urinary leakage and thus alle~iate urinary incontinence in women, including stress urinary i nco~t; n~nc~, In the pre~erred embo~i -nt, the cap is packaged in a o~ding clear plastic cont~; n~r or envelope diagrammatically illustrated at 50. This maintains the cle~nl;n~ss of the cap prior to usage. Such envelopes are known in the art and can comprise thin plastic films which can be see through or opaque.
other conv~nt;on~l packages can be used to store and transport the urethral cap to ~-;nt~;n cle~nl ;n~ss. In some cases, a plurality o~ caps can be packaged in a single package or no package need be used In some cases, the caps o~ this invention WO96~9991 PCT~S96/09032 can be sterilized. Preferably, the caps lO of this invention are manu~actured and p~ck~ged under and meeting ISO 9000 st~n~rds to provide cl~nl;n~ss, ~-n~f~cturing quality and lot control.
Thus, cont~m;n~tion, ;n~lll~;n~ bacterial cont~m;n~tion, is r;n; m; ~ed.
The urinary caps of this inV~nt; on can be sterilized to reduce the risk of infection or irritation to the skin.
Sterilization is not required since ~he device is external to the body and does not have any c~ nt passing within the urethra.
It has been found that caps of this type are useful for long ?eriods of time and m~; nt~; n the contact with the s~in in sealing arrangement for periods of 2 to 6 hours or more in some cases.
While specific embo~m~nts of this invention have been shown and described, it will be obvious to those skilled in the art that many variations are possible. The particular materials, integral nature, geometric con~iguration o~ the devices o~ this ~nvention can vary greatly. In all cases, a pressure differ~nti~l is instrnm~nt~l in providing a body contacting seal to alleviate conditions of ;n~ont;n~ncy which seal acts along with a mech~n; cal closure of the meatus. The seal ~ormed by the flange 13, portion 14 and the body by the air pressure dif~erence between the ~h~mh~r and atmosphere and the adhesive contact i~
used, is sufficiently strong to withstand and to prevent urinary flow out of the cap over long periods o~ time at urinary pressures normally encountered at the urethral orifice

Claims

What is claimed is:
Claims

1. A urethral cap for alleviating urinary incontinence, when applied over the meatus of the body of a user, said cap comprising a resilient at least partially deformable cap body having a hand griping portion, said body defining a chamber there within sized to allow for reciprocal resilient deformation of said cap body to provide a vacuum therein to hold said urethral cap on the body of a user and close the meatus of said body of the user, said cap body defining an encircling flange having a body contacting surface to act as a sealing surface with the body of a user.

2. A urethral cap in accordance with claim 1 and further comprising a sealing material covering said body contacting surface for aiding in preventing fluid flow between the body contacting surface and the body of an individual when said cap is in use.

3. A urethral cap in accordance with claim 1 wherein said encircling flange has an outer diameter of from about 2.3 to about 3.4 centimeters.

4. A urethral cap in accordance with claim 2 wherein said encircling flange has an outer diameter of about 3 centimeters.

5. A urethral cap in accordance with claim 1 wherein said chamber defines a central axis passing from a top of said cap to a bottom of said cap, with said bottom being defined by said encircling flange, said top to bottom having a height of about 2 centimeters.

6. A urethral cap in accordance with claim 1 wherein said cap is integrally formed of a resilient material which allows ease of application to the body of a user by deforming said cap chamber, applying said cap to the user body about the orifice of a urethra and releasing said deforming pressure to define an air pressure difference between said chamber and the atmosphere sufficient to seal said flange to the user and to prevent liquid flow therethrough at normal pressures encountered in urinary fluids expressed by the body, said cap further defining a meatus constricting surface to close said meatus when said cap is applied with said pressure difference acting to position said cap.

7. A urinary cap in accordance with claim 1 wherein said cap is formed of an FDA approved silicone rubber.

8. A urinary cap in accordance with claim 1 carrying a layer of the sealing material over said body contacting surface, and a release strip covering said sealing material.

9. A urethral cap in accordance with claim 8 and further comprising a second layer of sealing material over said release strip and a second release strip overlying said second layer of sealing material.

10. A urethral cap in accordance with claim 2 wherein said sealing material is a lubricant with, no adhesive properties.

11. A urethral cap in accordance with claim 2 wherein said sealing material is an adhesive.

12. A urethral cap in accordance with claim 1 wherein said cap conforms to ISO 9000 manufacturing standards.

13. A urethral cap in accordance with claim 12 wherein said cap is packaged in accordance with ISO 9000 manufacturing standards.

14. A urethral cap in accordance with claim 2 wherein said cap is integrally formed of a silicone rubber material compatible with and nonirritating to the skin of the body.

15. A urethral cap in accordance with claim 2 wherein said encircling flange has an outer diameter of from about 2.3 to about 3.4 centimeters.

16. A urethral cap in accordance with claim 5 and further comprising a sealing material covering said body contacting surface for aiding in preventing liquid flow between the body contacting surface and the body of an individual when said cap is in use.

17. A urethral cap in accordance with claim 16, wherein said cap provides a generally fustroconical inner surface adjacent said flange body contacting surface to aid in closing said meatus by compression.

18. A method for alleviating urinary incontinence of a user, said method comprising:
applying a urethral cap having an internal chamber over a urethra outer body orifice of a user, said cap defining a hand gripping portion and an encircling flange having a body contacting surface area which aids in sealing said urethral cap to the body of a user, employing air pressure below ambient atmospheric air pressure to maintain said cap in place, and removing said urethral cap to allow voiding when desired.

19. A method in accordance with the method of claim 18 wherein a sealing material is applied to said body contacting surface before application of said cap to the body orifice of a user, and said air pressure acts to compress and seal the meatus to urinary flow.

20. A method in accordance with the method of claim 19 wherein said urethral cap is applied by resiliently compressing said cap, contacting said body contacting surface area with the body of the user, positioning a central axis of said cap over said urethra outer body orifice, and allowing said cap to resiliently return towards its original configuration

21. In a method of preventing unwanted urinary flow from the body of a female user, the method comprising:
applying a urethral cap over the orifice of the urethra and maintaining said cap in place on the body of the user by the use of air pressure to prevent urinary flow beyond said cap.

22. In a method of alleviation of urinary incontinence, wherein a hand applied device is used to prevent unwanted urinary flow, the improvement comprising, using a hand applied and removable device mounted externally of the body to close the meatus of the body to urinary flow, and removing said device from the body to allow the meatus to return to its opened natural state and permit urinary flow when desired.

23. A urethral cap for alleviating urinary incontinence when attached to the body of a user, while minimizing infection of the user by avoiding the use of components of said cap passing into or through the urethra of a user, said cap comprising a hand gripping portion for use in mounting said cap over the urethra external orifice of said body, said cap having an interior surface and an exterior surface and defining an interior chamber for establishing a pressure differential between said urethral cap and the atmosphere to aid in maintaining said cap in position attached to said body, a meatus compressing and closure surface, and an encircling flange having a body contacting surface to act as a sealing surface with the body of a user, said encircling flange being constructed and arranged to surround said urethral external orifice.