CA2192193A1

CA2192193A1 - Female anti-incontinence device

Info

Publication number: CA2192193A1
Application number: CA002192193A
Authority: CA
Inventors: Saad Juma
Original assignee: Individual
Current assignee: Individual
Priority date: 1994-06-09
Filing date: 1995-06-07
Publication date: 1995-12-14
Also published as: US5417226A; EP0765143A1; WO1995033420A1; AU2701695A

Abstract

A female anti-incontinence device is described which comprises two flexible discs attached to a flexible stem. The device is inserted into the urethra so that the larger disc occludes the bladder neck during sudden tensing of the abdominal muscles, while the smaller disc remains outside the urethra and prevents migration of the device into the bladder. The device is compact, easy to use, and, since it contains no moving parts, grooves or chambers, there is minimal chance of bacterial colonization and urinary tract infection.

Description

2 ~ 9 2 i 9 3 FEMALE ANTI-INCONTINENCE DEVICE
Field of the Invention This invention relates to a device used for female i"cul,li"~"ce. More 5~ y, it relates to a non-irritating easy to use device which can be inserted 5 and removed by the individual as desired.
. Background of the Invention u~ ellce is a major health problem in the United States and accounts for auulu~ill 'y $1û billion of our annual health care costs. It is estimated that over 1û million individuals suffer from urinary i"uull~ ce 60-7û% of which are 10 females. Although there are several types of female i~ ~u~"Li"~"ue stress ~ u~ ce or stress and urge i"co"li"e~ce is the most common. Stress i"~.~"li"t:". e is triggered by sudden tensing of the dLdul "i, lal muscles which occurs during coughing laughing and certain physical activities. It is caused by dLI~ulll, in the anatomy of the bladder outlet structures the sphincter and 15 urethra. This problem is most pronounced in the elderly female pr.pll , due tû
prolapse of the uterus which distorts the geometry of the bladder neck resulting in a 30% i"~;u,ltill~llce rate in women over 60 years of age. This problem causes acute ~IIlLalla ~ lll and inhibits physical and social activity.
Many methods and devices for managing i"..~r,li"ellct: are currently available. In younger patients surgery is the method of choice for severe i,,~.~,,li,,~llc~. However in older individuals the risk of cc." ,~ makes this option illlula~ al. In addition in mild cases surgery is not a desirable option.Another common method of managing i"u~"li"ellce is the use of an absorbent pad placed over the urethral opening which is nonhygienic u~ ~u~ rul I~Llc: and does not prevent the involuntary urination. Other less effective i,,cu,, ,~"ce treatment methods include pl~allllaculll~ld~uy~ exercise electrical stimulation and periurethral injections.
ce devices disclosed in the prior art rely mainly on urethral occlusion. Nielsen et al. (J. Urol. (1990) 144:1199-1202) and U.S. Patent 5 û82 0û6 to Jonasson disclose an i"~.~"li"~"u~ device having a shaft with one or more knobs placed along the shaft which occludes the urethra. This design relieson the presence of at least one knob inside the urethra at all times which ,t:u,t:se:"ts a source of continuous irritation to the patient. In addition the constant WO 95/33420 PCTrUS95rO7340 2~92193 -2~
pressure exerted on the walls of the urethra over time will cause urethral dilation, resulting in leakage of urine around the device. This urethral dilation can allow expulsion of the device due to increased bladder pressure, resulting in i"-.~, liil ,~"ce.
U. S. Patent 5,090,424 to Simon et al. discloses a flexible urethral plug consisting of a soft inflatable plastic catheter and a lldll~JUI LdiJlt: liquid. The fluid is introduced through a check valve to inflate the device within the urethra, the bladder neck or the bladder. This device is c~ u",e and, since it contains a chamber and a valve, it is i" I,UOssiiJl~ to prevent bacterial culu~ dliul1 of the device leading to possible urinary tract infection. In addition, the chamber and valve can malfunction, resulting in balloon deflation and potential leakage of urine. Valve malfunction can also cause either expulsion of the device, resulting in i, ,.,u, llil ,ellce, or retention of the device which will require medical intervention for its removal.
U. S. Patent 3,372,695 to Beliveau et al. describes an illCO~lillellGe device having a rod with two retainer portions extending into the bladder to keep the device in position. The ..~r,li"~"ce Ill~ul Idl ,i~", of this device is the rod only which will lose its occlusive action over time due to urethral dilation, resulting in leakage of urine around the rod. In addition, this device will irritate the urethra and, since it has moving parts which are illl,uossiiJl,: to keep clean, there is a risk of bacterial 2û growth and the potentiai for urinary tract infection. Moreover, valve malfunction can result in either expulsion or retention of the device.
U.S. Patent 3,797,478 to Walsh et al. discloses an i"u~"t;"t:"~ device having two inflatable collars and an inflatable stem. Since the inflatable stem occludes and applies constant pressure on the urethra, this will result in urethral 25 wall relaxation and leakage around the device. Moreover, this device requires the use of a syringe to inflate and deflate the collars and stem, making it difiicult to use, especially by patients with arthritis. In addition, it is difficult to keep the device free of bacteria.
U. S. Patents 3,64~,929 to Bonnar and 4,920,986 to Biswas teach 30 i, .~ld~;,,al i,,..u,, ,~llce devices which can expand to exert pressure on the bladder neck, thus restricting the flow of urine. These methods do not rely on occluding the bladder via insertion of a device into the urethra.

WO 95/33420 , ~ " ~ /~540 2192~93 _3_ There is a need for a female i~uu~Li~ ce device which is simple to use, easy to manufacture, easy to clean and which will not cause irritation to either the urethra or the bladder.
- Summarv of the Invention One ~",i o~i",~"I of the present invention is a removable device for J. preventing involuntary urination in female patients, Culll~Jli;,;l,y.
a flexible stem having a first end and a second end;
a first flexible disc having a perimeter, a first 10face and a second face, said first face of said first disc attached to said first end of said stem;
a second flexible disc having a perimeter, a first face and a second face, said first face of said second disc attached to said second end of said stem; and 15a projection attached to the second face of at least one of said discs.
In another aspect of this ~",i odi"":"L, the projection attached to either said first or said second disc is attached to a string. AlLe:ll "/cly, both i~uj~Iio~s are attached to a string. The device can also contain a string longitudinally ~"li edded 20 wlthin the stem and the p~uj~l,liu~s, such that the string extends beyond thep~uje~Liuils and one of the ~Ale~ ,iull, of the string is removed prior to insertion of the device. Adv~ Ldgeously, the device is made of a flexible, biocu",, "'' material which is resistant to d~yl ' " ~ by urine. Preferably, the iJiU~,OIlllJd~iiJIe material is an elastic polymer. Most preferably, it is Kraton G, silicone or 25 pol~v;"JI~,I,Iu,i~. According to another aspect of this preferred ~",i~o~i",e"L, the stem is more flexible along its lateral axis than along its longitudinal axis.
Advantageousiy, the diameter of the first disc is greater than the diameter of the second disc. Preferably, the diameter of the first disc is between about 1.0 cm and about 2.0 cm. Most preferably, the diameter of the first disc is 1.5 cm. According 30 to another aspect of this e",i o.li",t",l, the diameter of the second disc is between about 0.~ cm and about 1.5 cm, most preferably 1.0 cm. Further, the discs are attached to the stem at their centers and join the stem at right angles. In WO 95/33420 2 ~ 9 2 1 9 3 - PCT/I~S95/07340 - 4 ~
a. l ordal~ce with the invention the length of the stem is between about three and about six ce"~i",~ and the diameter of the stem is about 0.4 cm.
Another el, ILoui, "a"~ of the invention is a method of preventing i"co"li"e~Iu~infemale patients cu,,,u,i~;,,g inserting the above-described device intothe urethra 5 Preferably the device is removed prior to voiding of urine. In another aspect of this preferred e",Lodi",a"I the removing step comprises pulling on the string.
Brief Description of the Drawinqs Figure 1 is a side elevational view of the female anti-i"u~"Ii",:,)ct, device.
Figure 2 is an end view from one end of the female anti-i"co, ,Ii, ,~:l ,ca device.
Figure 3 is an end view from the opposite end of the female anti-i,,,~,,Ii,,t:l~ua device.
Figure 4 is a schematic diagram showing the device positioned within the female urinary tract.
Detailed DescriDtion of the Invention The present invention provides a device for the treatment of female i,,cull ,~ e. This device is used in place of other c~,,,bt:,~ullle methods such as urethral plugs surgical ,. '_ ""~"~ of the bladder neck and plla,,,,a~;ull,e,duy.
Since the present device relies on occlusion of the bladder neck without urethral occ~usion the device avoids urethral irritation and dilation. Accordingly the present 20 invention, t~ e, .;~ a signlficant improvement over i"-.~"Li"el 'ce devices disclosed in the prior art.
The device of the present invention can be made of a any of a variety of biu~.u," ' ' elastic polymers. Desirable u I IdldU~ ti~.~ of the material include softness flexibility resistance to dey,add~iul1 by urine and ability to dwell for short 25 periods of time in the urethra and bladder neck. Suitable materials include silicone Kraton G or Polyvinylchloride (PVC). As used herein the terms "flexible" and "flexibility" relate to being ,~uo"_:~c or adaptable to Ille~llàl~i. dl d~Fulll,d~iull as would be encountered when the device is inserted into the urethra and bladder neck. The biu~ d~ibll: material has a suitable hardness preferably 25-50 D as 30 measured by a durometer, to impart sufficient flexibility to the device.
Referring to Figures 1-3 the device 10 includes a stem 15 having a diameter of 0.4 cm and a length designed to properly position a disc 20 with respect to the bladder neck of the patient in which the device will be inserted. The length will WO 9S/33420 2 1 9 2 1 9 3 _5_ PCT/IJS9S/07340 vary d~,u~l "~i"y on the length of the urethra and other al ' "i.,al structures of the patient. Thus, the stem 15 can be produced in a variety of lengths to aCGGIIIII._ ' ' dl ' lliUdl variation. Exemplary stem lengths are in the range of 2-7 C~l l~il l l~lc:l a (cm). Preferred t:" IL,o-li" ,_"ts of the device are produce with stem 5 lengths of 3, 4, 5 and 6 cm. This variation in stem length is due to dlldlulllicdl ' variation of the human urethra and is important in proper posiliù, ,i"y of the device in the urethra. The stem must not be too long, or the device will reach up too far inside the bladder and will move around, causing irritation by sitting illl,ulup~7l1y on the bladder neck. However, the stem must be long enough so the device will 10 reach into the bladder and seal the bladder neck to prevent leakage of urine. The stem can be constructed to be less flexible along the longitudinal axis to allow easy introduction of the device, and more flexible in the lateral direction to allow molding to and flexibility within the urethra, thus avoiding urethral irritation.
Two soft, flexible discs 20, 25 having a radial edge and two suL,~d"t;..l:~
planar faces are either molded or attached to the ends of the stem. The discs and the stem can have different rigidities to provide greater functional flexibility to the device. In a preferred ~",L~uui",t:"l, the stem is more rigid than the discs. The discs can be either the same or different sizes. In a preferred ~IllLodi,,,~,,L, disc 20 is between about 1.0 and about 2.0 cm in diameter. In a particularly preferred t:"lLGdi",~"l, disc 20 has a diameter of 1.5 cm. In a preferred ~:IllL,u.lillle:lll, disc 25, attached at the end of stem 15 opposite disc 20, has a diameter between about 0.5 and about 1.5 cm. In a particularly preferred t:",L,O.li"n:"L, disc 25 has adiameter of 1.0 cm and stem 15 is attached to the center of discs 20 and 25.
The diameter of the larger disc 20, which forms the seal at the bladder neck, is such that it will form a tight seal, but will not irritate the wall of the bladder. If the disc has a diameter much larger than about 2 cm, it can cause irritation to the bladder and can touch the bladder area known as the trigon, causing the urethra to spasm. In addition, a disc having a larger diameter will cause greater ~ia~.ul 1 l t upon insertion of the device.
0 A rounded projeGtion or nub 30 between about 0.2 cm and about 1.0 cm in length, most preferably 0.5 cm, and having the same diameter as stem 15 can be attached to disc 20 in order to facilitate introduGtion of the device into the urethra.
Another projection 35 can be attached to disc 25. In a particularly preferred W095/33420 2 1 9 2 ~ 9 3 , `, ~ ` ~CT~S95/07340 Illbo~ lel,l ,.,lujdLliùl~s 30 and 35 are attached to the centers of the faces of discs 20 and 26 respectively opposite the junction of stem 15. The ~IUj~Lliull~
provide a guide for easy insertion of the device into the urethra. The p,ujdLIions preferably have a length between 0.2 and 1 cm. If the projection 30 is much longer 5 than about 1 cm it can irritate the collapsed wall of the bladder upon insertion. If the ~,ujeLIiu,~a are smaller than about û.2 cm they are less able to serve as noticeable guides for insertion.
Optionally a string 17 can be attached to either or both plUj~Lliul~s to allow facilitated removal ofthe device. In a particularly preferred ~:",~odi",e"l the string 1û can be longitudinally e",bedded within the stem 15 and l ,ujt:, ti~lls 30, 35 such that it extends beyond these PIU;~:LI;OI~S. The user can then remove the string from the end of the device to be inserted into the urethra while the other end of the string will remain outside the urethra to allow facilitated removal of the device. Thus the user will have the option of inserting either one end or the other into the urethra, 15 d~:ut~ on which disc is more effective in occluding the bladder neck.
Discs 20 and 25 can have either the same or different Illi~ h"esses. In a preferred ~luo~ ,I each disc has a thickness between about 0.1 cm and about 0.5 cm. In a particularly preferred ~",uudi",t:"l each disc has a thickness of 0.1 cm. The thickness of the discs is selected to retain both flexibility and adequate 20 structure.
Referring to Figure 4 the device is inserted by the individual into the urethra 45 with disc 20 entering first using the projection 30 as a guide. Once the device is inserted disc 20 collapses like an umbrella then flattens out once it has entered the bladder 55. The flexibility of disc 20 which allows it to collapse during insertion 25 will reduce patient discomfort and will lessen the chance of irritating bladder neck 50 and the wall of urethra 45. Disc 25 sits just outside the urethra 45 and prevents the device from migrating upward into the bladder 55. The diameter of the stem 15 is such that it does not contact the walls of the urethra 45 upon insertion removal or when the device is resting inside the bladder 55 thus "i"i",i~i"~ the 30 possibility of urethral irritation. However the stem 15 is thick enough to maintain its structural integrity upon insertion and removal of the device.
In an altemative ~"l~odi",~"l the device can be inserted with disc 25 entering first. In this case, the string 17 will be attached to projection 35 in place WO 95/33420 2 1 9 2 ~ 9 3 ' ~ ` t i ' PCTNS95/07340 of projection 30. The dual disc design increases the flexibility of the device, since the individual will be able to insert into the bladder whichever disc is more effective in forming a seal to prevent the leakage of urine.
In yet another alternative ~"ILo-li,"t:"I, an e~"Ledded string extends beyond 5 both of the two ~.",j~.,liolls, and is cut by the user at one end, thereby allowing the individual to insert into the bladder whichever disc is more effective in forming a seal to prevent i"~,~"li"el,ce.
As an alternative means for introduction of the device, a sheath of sufficient diameter to allow passage of the device, but not large enough to irritate the 10 urethra, is inserted into the urethra, leaving a small portion outside. The device can then be inserted into the sheath, either manually or with a plunger, with the larger disc inserted f rst. The sheath is then removed, leaving the device inside the urethra with the smaller disc remaining outside.
During an episode which causes tensing of the dL,d~",i"al muscles, herein 15 referred to as a stressful episode, pressure forces the device downward against the neck of the bladder, forming a seal to occlude the bladder neck, thus preventingthe leakage of urine. The device thus occludes the bladder neck only during stressful episodes; at other times it simply sits inside the urethra with the larger disk resting on the bladder neck. The device applies minimal pressure to the 20 bladder neck and urethra when not acting as a seal, and applies just enough pressure (equal to the pressure in the bladder) to preserve c~"li"c:"~,e during a stressful episode. Since the stem does not occlude the urethra, it does not participate in c~ "~,e, it mainly serves a guidance and support function. Since the device does not exert pressure on the walls of the urethra, the chance of 25 urethral irritation and urethral dilation with ~50~ 'i leakage around the device is greatly minimized.
The disc shape of the ends of the device is important for preventing the device from migrating into or out of the bladder as compared to a more sphericalor elliptical shape. The taper on an elliptical or spherical device could lead to a 30 dilation of the bladder neck or urethra, resulting in potential migration of the device.
One particular adv...l~a~e of the device of the preferred ~,,II,~,di,,,t:,,l is that it lacks on such taper. The lack of any taper on this preferred device together with its WO 95/33420 2 ~ 9 2 1 9 3 ~ ~ ~ . PCT/US95/07340 abrupt transition from the diameter of the stem to the disc makes migration virtually i" ,,uos:,il,le.
The device is ordinarily inserted after voiding of urine, for example, prior to a social ~:llydy~lllt:lll. When the individual feels the urge to void, the device is 5 removed by pulling on the smaller disc or on the string attached to the disc~ During removal, the larger disk folds upwards, similar to an inverted umbrella, allowing for easy passage of the device through the urethra Advantageously, the device can be cleaned with soap and water prior to ,~i"~,liul1 Alternatively, the device can be disposed of and a new device inserted 10 when desired The ~i~,u. ' `'`ty of the device is feasible due to its simple, one-piece design and low manufacturing cost Another particular advantage of the device is its lack of moving parts, grooves or chambers, present in prior art devices, which bacteria can colonize This can lead to an increased frequency of urinary tract infections in the prior art devices since it is illl,uua~ le to keep the 15 moving parts, grooves and chambers free of bacteria Since the instant device can be thoroughly ~i~i"'~,vt~d, the potential of urinary tract infection is greatly minimized. The lack of moving parts also makes the device durable and cost effective to produce The lack of valves and moving parts also ensures that the device will not undergo " ~t:ul Idl li~;dl failure, a problem ~.so~ d with prior art anti-20 i"..o"li"el~ce devices. Thus, the device of the present invention is not subject toexpulsion or retention due to ",eul,al,ical failure In addition, the lack of moving parts such as pumps, valves and syringes will enable individuals with manual dexterity problems, such as arthritis, to easily use the device.
To determine the dplJIu,ulidL~ length of the device for each individual, a 25 calibration device can be used~ In a preferred ~",bodi",~:"~, the calibration device can be suL.:.ldl 'l~ similar to the device itselF~ Such a calibration device includes a calibrated flexible stem of 1-6 cm attached to two flexible discs~ The calibration device is inserted until the larger disc enters the bladder, at which time the resistance will decrease since the disc is no longer within the urethra The 30 distance is then d~ ""i"ed by reading the mark on the stem~ In an al~", 'i~
Lodi,l,~,,l, the entire device can be inserted The device is then retracted by pulling on the smaller disc until resistance is felt when the device just enters the urethra~ The distance is then dt:~ll"i"ed by reading the calibration mark~

~ W095/33420 2 1 92 ~ 9 3 9 PCT/US95/07340 To determine the efficacy of the device a pilot clinical study is performed as described in the following example.
EXAMPL~
Clinical Studv Usina l"cu,lli"el~c~ Device For inclusion in the study the individual must be a female with i, ,. u, ,~i"~llce must be able to insert and remove the device must not have a urinary tract infection and cannot be pregnant.
Each patient is given a plt:uu~ldLive evaluation including history of urinary disorders urinalysis and urine culture. The patient is then given the pad weighttest a clinical da~e:.:.",~r,l of stress i"u~"~ "u~. This as~ss",~"t involves having the patient void followed by introduction of a volume of liquid into the bladder through a catheter. An absorbent pad is then aKached to cover the urethral opening. The patient then performs a physical activity after which time the pad is weighed to determine the amount of liquid involuntarily voided. The patient is also subjected to cystoscopy to determine whether the interior of the bladder is nomnal. A series of tests called u~udyi~a~iu studies is also performed to obtain an overall ass~as",t:~l of bladder function. A qu~aliullll ~ is also a~l"i(,;~ d todeterminelevelofi"c~"li"~llc~ frequency urgency andotherrelevanti" ",d~iûn.
The device is then given to the subjects who i"""edidl~:ly begin to use it as desired. The subjects return for office visits at for example 1 month 3 months and six months. A urine culture is performed at 1 and 3 months to detennine frequency of infection and a pad weight test is performed at 3 months to determine efficacy of the device in p,~-~ ., ;.,g stress i,,cu,lli,,~:l,ce. A aiylliriudll~ly d~ul~ds~d volume of liquid voided in the presence of the device as compared to its absenceas well as no significant incidence of infection will indicate the efficacy and safety of the device.
Although this invention has been described in terms of certain preferred ~",I,odi",er,l~ and _ ~s other ~ L,odi"":"ts and l" na that are apparent to those of ordinary skill in the art are also within the scope of thisinvention. Accordingly the scope of the invention is intended to be defined onlyby reference to the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A removable device for preventing involuntary urination in female patients, comprising:
a flexible stem having a first end and a second end;
a first imperforate flexible disc having a perimeter, a first face and a second face, said first face of said first disc attached to said first end of said stem;
a second flexible disc having a perimeter, a first face and a second face, said first face of said second disc attached to said second end of said stem; and a projection attached to the second face of said first disc.

2. The device of Claim 1, wherein a string is attached to said projection.

3. The device of Claim 1, wherein said projection is continuous with said stem.

4. The device of Claim 1, wherein a projection is attached to the second face of each of said first and second discs.

5. The device of Claim 2, wherein said string is longitudinally embedded within said stem and said projection, whereby said string extends beyond said projection.

6. The device of Claim 4, wherein a string is attached to each of said projections.

7. The device of Claim 1, wherein said device is made of a flexible, biocompatible material.

8. The device of Claim 7, wherein said material is resistant to degradation by urine.

9. The device of Claim 7, wherein said biocompatible material is an elastic polymer.

10. The device of Claim 7, wherein said stem is more flexible along its lateral axis than along its longitudinal axis.

11. The device of Claim 9, wherein said polymer is Kraton G, silicone or polyvinylchloride.

12. The device of Claim 1, wherein said first disc is greater in diameter than said second disc.

13. The device of Claim 1, wherein the diameter of said first disc is between about 1.0 cm and about 2.0 cm.

14. The device of Claim 13, wherein the diameter of said first disc is 1.5 cm.

15. The device of Claim 1, wherein the diameter of said second disc is between about 0.5 cm and about 1.5 cm.

16. The device of Claim 15, wherein the diameter of said second disc is 1.0 cm.

17. The device of Claim 1, wherein said discs are attached to said stem at their centers.

18. The device of Claim 1, wherein said stem joins said discs at right angles.

19. The device of Claim 1, wherein the length of said stem is between about three and about six centimeters.

20. The device of Claim 1, wherein the diameter of said stem is about 0.4 cm.

21. A removable device for use in preventing involuntary urination in female patients, said device comprising:
a flexible stem having a first end and a second end; and an imperforate flexible disc having a perimeter, a first face and a second face, said first face of said disc attached to said first end of said stem.

22. A method of preventing incontinence in female patients, comprising inserting an anti-incontinence device according to any of the foregoing claims into the urethra of said patient so as to form a seal to occlude the bladder neck of said patient, said first end of said stem being inserted into the urethra prior to said second end thereof, and said imperforate disc being positioned within the bladder so as to provide the seal to occlude the bladder neck.

23. The method of Claim 22, wherein said device additionally comprises a second flexible disc having a perimeter, a first face and a second face, said first face of said second disc attached to said second end of said stem.

24. The method of Claim 22, further comprising the step of removing said device prior to voiding of urine.

25. The method of Claim 22, wherein said device additionally comprises a projection attached to the second face of at least one of said discs.

26. The method of Claim 25, wherein said device additionally comprises a string attached to one of said projections, and wherein the removing step comprises pulling on said.

27. The method of Claim 24, wherein said device comprises a projection on each of said discs and a string attached to each of said projections, and wherein the method additionally comprises cutting one of said strings prior to the inserting step.