WO2000066029A1

WO2000066029A1 - Bladder control device and method for treating female urinary incontinence

Info

Publication number: WO2000066029A1
Application number: PCT/US2000/011604
Authority: WO
Inventors: Tu T. Pham
Original assignee: Hk Medical Technologies Incorporated
Priority date: 1999-04-30
Filing date: 2000-04-28
Publication date: 2000-11-09

Abstract

A device (20) and method for treating female urinary incontinence is provided. A device (20) in accordance with the invention includes a sleeve (22) having a distal end (26), a proximal portion (24), and a lumen (30) extending therebetween. A plurality of distal members (50) are disposed at the distal end (26) of the sleeve (22). The distal members (50) may be selectively placed in an insertion position, wherein the distal members (50) form a generally conical distal tip (102). The distal members (50) may also be selectively placed in a second position wherein the distal members (50) retain the device in the urethra by contacting the bladder floor.

Description

BLADDER CONTROL DEVICE AND METHOD FOR TREATING FEMALE URINARY INCONTINENCE

Field of the Invention The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to intraurethral devices and methods for controlling urine flow.

Background of the Invention Female urinary incontinence is a common medical condition, having widespread economic and social ramifications. The difficulty and embarrassment associated with urinary incontinence often causes the affected person to limit her social activities. In some cases, pads or diapers are used to absorb the uncontrolled seepage of urine. These absorbent items must be changed frequently, creating an ongoing economic burden. The wearing of absorbent undergarments may also restrict the type or style of clothing which the patient may wear. More seriously, skin irritation and other hygienic difficulties often result from the lingering presence of captured urine against tender urogenital

tissues. An additional method of treating urinary incontinence is the use of bladder flow control devices, sometimes referred to as artificial sphincters or prosthetic urethral valves. A bladder flow control device may be positioned in the urethra of a patient to control the flow of urine out of the bladder. It is desirable for the placement of the bladder flow control apparatus in the urethra to be performed easily and non-surgically. Once the bladder flow control device is placed, it is desirable that it be safely and securely retained in the urethra. Optimally, the device surfaces which contact the human body will be formed of biocompatible materials, to lessen chances of inflammation in patients. Summary of the Invention

The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to intraurethral devices and methods for controlling urine flow. An intraurethral device in accordance with the present invention includes a sleeve having a distal portion and a proximal portion. A proximal retainer is fixed to the proximal portion of the sleeve and a plurality of distal members are disposed at the distal end of the sleeve.

The distal portion of each distal member is preferably shaped so that the distal members combine to form a generally conical distal tip. The proximal portion of each distal member is fixed to the distal portion of the sleeve by a linking means. In a presently preferred embodiment, the linking means includes a ring and elastomer hinges. The elastomer hinges may be deformed to allow the distal members to assume a variety of positions. An actuating means may be used to selectively place the distal members in a number of positions. When the actuating means is not acting upon the distal portions of the distal members, the elastomer hinges are free to assume a natural, undeformed state. When the elastomer hinges are in a natural, undeformed state, the distal members assume a position adjacent to each other. In this position, the distal members form a generally conical distal tip.

In a presently preferred method in accordance with the present invention, the distal members form a generally conical distal tip to aid insertion of the device into a patient's urethra. Also, in a presently preferred method, the actuating means may selectively place the distal members in an outwardly extending position. When the distal members are deployed in an outwardly extending position, the distal members serve to prevent proximal motion of the intraurethral device out of the patient by contacting the bladder floor. Distal motion of the intraurethral device into the patient is prohibited by the proximal retainer fixed to the proximal end of the sleeve. This proximal retainer contacts the urethral labia.

In this manner, the intraurethral device is held within the urethra by distal members and the proximal retainer acting at opposite ends of the urethra.

An applicator for use in inserting an intraurethral device into a patient's urethra is also disclosed. The applicator includes a housing having a distal end and a proximal end. The proximal end of the housing includes a housing flange.

An applicator tip is fixed to the distal end of the housing. The housing further includes a wall defining a lumen.

An applicator rod is disposed in the lumen of the housing. The applicator rod includes a distal end and a proximal end. A means for selectively connecting the distal end of the applicator rod to the proximal end of an intraurethral device is disposed at the distal end of the rod. -An actuating pad is fixed to the proximal end of the applicator rod. The applicator rod also includes at least one flange. A spring is disposed in the lumen of the housing, the distal end of the spring being seated on the distal tip member, and the proximal end of the spring being seated on the flange rod. In a presently preferred embodiment, the spring urges the applicator rod in a proximal direction.

A method of positioning an intraurethral device in a urethra utilizing the applicator typically begins with the steps of urging the applicator rod in a distal direction and connecting the distal end of the applicator rod to the proximal end of the intraurethral device. In a presently preferred embodiment of the present invention, the housing flange is adapted to receive two of the physician fingers and the pad is adapted to receive the physicians thumb. In this presently preferred embodiment, the thumb is used to apply pressure to the pad urging the applicator rod in a distal direction relative to the applicator housing. Applying pressure to the pad also has the effect of compressing the applicator spring. This presently preferred embodiment allows for simple, one-handed operation of the applicator.

Once the distal end of the applicator rod is connected to the proximal portion of the intraurethral device, the pressure applied to the pad may be released. The release of the pressure on the pad allows the applicator spring to expand. When the applicator spring expands it acts upon the actuating means of the intraurethral device. In this way, the applicator causes the distal members of the intraurethral device to assume a position in which the distal members form a generally conical distal tip. The intraurethral device is held in this desirable position by the applicator. The distal tip may now be inserted into the urethra. The generally conical shape of the distal tip allows for easy insertion.

Once the distal tip has entered the urethra, the remainder of the intraurethral device may be urged into the urethra until the proximal retainer is disposed proximate the urethral labia. Having placed the intraurethral device in the urethra, the applicator may now be disengaged from the urethral device. When the applicator is removed, the actuating means of the intraurethral device will be free to act upon the proximal end of the distal members of the intraurethral device. The actuating means of the intraurethral device causes the distal members to assume a deployed position in which the distal members extend away from the sleeve of the intraurethral device. When the intraurethral device assumes this deployed position, the distal members serve to prevent proximal motion of the intraurethral device out of the patient by contacting the bladder floor. Distal motion of the intraurethral device into the patient is prohibited by the proximal retainer fixed to the proximal portion of the sleeve. In this manner, the intraurethral device is held within the urethra by the distal members and the proximal retainer acting at opposite ends of the urethra.

Brief Description of the Drawings Figure 1 is a cross-sectional plan view of an intraurethral device in accordance with an exemplary embodiment of the present invention;

Figure 2 is a cross-sectional plan view of the intraurethral device of Figure 1; Figure 3 is a perspective view of an assembly including an intraurethral device and an applicator in accordance with an exemplary embodiment of the present invention;

Figure 4 is a perspective view of an applicator rod in accordance with an exemplary embodiment of the present invention;

Figure 5 is a cross-sectional perspective view of a valve housing in accordance with an exemplary embodiment of the present invention;

Figure 6 is a perspective view of a crown in accordance with an exemplary embodiment of the present invention; Figure 7 is a plan view of an intraurethral device in accordance with an exemplary embodiment of the present invention disposed in the urethra of a patient;

Figure 8 is a perspective view of an assembly in accordance with an exemplary embodiment of the present invention; and Figure 9 is a perspective view of an assembly in accordance with an exemplary embodiment of the present invention.

Detailed Description of the Invention The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements. All other elements employ that which is known to those of skill in the field of the invention. Those skilled in the art will recognize that many of the examples provided have suitable alternatives which may be utilized.

Figure 1 is a cross sectional plan view of an intraurethral device 20 in accordance with the present invention. Intraurethral device 20 includes a sleeve 22 having a distal portion 26 and a proximal portion 24. A proximal retainer 28 is fixed to proximal portion 24 of sleeve 22. Proximal retainer 28 serves to prevent distal motion of sleeve 22 into the patient by lying against the urethral labia. Sleeve 22 includes a sleeve wall 32 defining a central lumen 30 and a proximal orifice 33.

A valve housing 40 is disposed in lumen 30 of sleeve 22. Naive housing 40 includes a distal portion 42 and a proximal portion 46 having a proximal orifice 48. Valve housing 40 is adapted to contain a flow control valve assembly (not shown in Figure 1). Two examples of flow control valve assemblies which are suitable for inclusion in valve housing 40 are described by Kulisz et al. in U.S. Patent No. 5,437,604 entitled NONSURGICAL INTRAURETHRAL BLADDER CONTROL DEVICE, and U.S. Patent Application Serial No. 09/207,821 by Migachyov and entitled VALVE FOR BLADDER CONTROL DEVICE, the disclosure of each being hereby incorporated by reference. Those of skill in the art will appreciate that other flow control valves may be used in conjunction with intraurethral device 20 without departing from the spirit or scope of the present invention.

Intraurethral device 20 also includes a plurality of distal members 50 each having a distal portion 52 and a proximal portion 54. In the embodiment of Figure 1, distal members 50 are adjacent to each other. The distal portion 52 of each distal member 50 is preferably shaped so that distal members 50 combine to form a generally conical distal tip 102 when they are positioned as shown in Figure 1. In a presently preferred method in accordance with the present invention, distal members 50 are positioned as shown in Figure 1 to aid in inserting intraurethral device 20 into the urethra of a patient.

Proximal portions 54 of distal members 50 are fixed to distal portion 26 of sleeve 22 by a linking means 60. In the embodiment of Figure 1, linking means 60 includes elastomer hinges 62 and a ring 64. Elastomer hinges 62 may be deformed to allow distal members 50 to assume positions other than the position shown in Figure 1. The position of distal members 50 in Figure 1 is labeled with element number 100.

Figure 2 is a cross sectional plan view of intraurethral device 20 of Figure 1 with distal members 50 in a second position 200. First position 100 of distal members 50 is shown with phantom lines in Figure 2. Distal members 50 may be urged from position 100 to position 200 by an actuating means 300. Actuating means 300 applies a force to proximal portions 54 of distal members 50 causing the angular position of distal members 50 to change. Elastomer hinges 62 deform to allow the angular position of distal members 50 to change. In the embodiment of Figures 1 and 2, actuating means 300 includes a crown 310 and a spring 304. Crown 310 includes a base 312 and an engaging member 314. Spring 304 is biased to act distally upon proximal end 46 of valve housing 40. Valve housing 40 transfers the force of spring 304 to crown 310. Engaging member 314 of crown 310 acts upon proximal portions 54 of distal members 50.

In the embodiment of Figures 1 and 2, crown 310 is fixed to a distal portion 42 of valve housing 40. Distal portion 42 of valve housing 40 includes a plurality of grooves or recesses 44. Recesses 44 are adapted to receive a base 312 of crown 310 and/or engaging member 314 of crown 310. Other methods of fixing crown 310 to distal portion 42 of valve housing 40 may be used without deviating from the spirit or scope of the present invention. Examples of methods which may be suitable in some applications include a threaded joint, a welded joint, and an adhesive joint. Embodiments of the present invention have also been envisioned in which crown 310 is an integral part of valve housing 40.

Proximal portion 24 of sleeve 22 includes recesses or slots 144. Recesses 144 are adapted to receive a retaining member 320. Retaining member 320 supports spring 304. Spring 304 is biased to act upon both retaining member 320 and proximal end 46 of valve housing 40. Distal portion 26 of sleeve 22 includes a distal stop 46. Distal stop 46 is adapted to arrest the distal movement of valve housing 40 and crown 310.

Those of skill in the art will appreciate that other embodiments of actuating means 300 are possible without deviating from the spirit and scope of the present invention. Examples of actuating means which may be suitable in some applications include elastomer springs, flat springs, and other materials known to those skilled in the art.

When actuating means 300 is not acting upon the proximal portions 54 of distal members 50, elastomer hinges 62 are free to return to a natural, undeformed state. When elastomer hinges 62 are in a natural, undeformed state, distal members 50 assume position 100 as shown in Figure 1. First position 100 may be referred to as an insertion position; and second position 200 may be referred to generally as a deployed position. It will be appreciated from the above discussion, that distal members 50 may be selectively placed in a number of positions in addition to the exemplary positions illustrated in Figures 1 and 2.

In the embodiment of Figure 1 , a force F is acting upon proximal end 46 of flow control valve 40. Force F has the effect of holding crown 310 in a proximal position and holding spring 304 in a compressed state. As shown in Figure 1, elastomer hinges 62 are free to assume their natural position when force F is applied to distal end 46 of valve housing 40.

In a presently preferred method in accordance with the present invention, intraurethral device 20 is placed in position 100 to aid in inserting intraurethral device 20 into a patient's urethra. When force F is removed, intraurethral device 20 assumes deployed position 200 as shown in Figure 2. When intraurethral device 20 assumes deployed position 200, distal members 50 serve to prevent proximal motion of sleeve 22 out of the patient by contacting the bladder floor. In a presently preferred embodiment, distal member 50, elastomer hinge 62, and ring 64 are all comprised of the same material. A presently preferred method of manufacturing this preferred embodiment is injection molding. Materials which may be suitable for this preferred embodiment include silicone rubber, and thermoplastic rubber. Also in a presently preferred embodiment, sleeve 22 is comprised of a thermoplastic material.

Figures 8 and 9 are both perspective views of an exemplary embodiment of distal members 50 and ring 64, in accordance with the present invention. Distal members 50 each have a distal portion 52 and a proximal portion 54. In the embodiment of Figures 8 and 9, distal members 50 are adjacent to each other. The distal portion 52 of each distal member 50 is preferably shaped so that distal members 50 combine to form a generally conical distal tip 102 when they are positioned as shown in Figure 8.

Proximal portions 54 of distal members 50 are linked to ring 64 by elastomer hinges 62 which are best shown in Figure 9. In Figures 8 and 9, elastomer hinges 62 are shown in a natural, undeformed position. Elastomer hinges 62 may be deformed to allow distal members 50 to assume positions other than the position shown in Figures 8 and 9. Elastomer hinges 62 define a slot 66 as shown in Figure 9 (not visible in Figure 8). In this exemplary embodiment of elastomer hinges 62, slot 66 allows engaging member 314 of crown 310 to pass through ring 64 and contact distal portions 54 of distal members 50.

Embodiments of intraurethral device 20 have also been envisioned which include a surface layer 90. Surface layer 90 may include an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. Surface layer 90 may also include materials such as hyaluronic acid, a hydrogel, or other materials to mimic mucous. Surface layer 90 may also include a lubricious material such as a hydrophilic hydrogel or a hydrophobic silicone to facilitate insertion and removal. It is envisioned that one or more of the above described surface layer materials can be used. Embodiments of intraurethral device 20 have also been envisioned in which the materials which comprise distal members 50 and sleeve 22 include one or more of the materials described immediately above. A method of inserting intraurethral device 20 in accordance with the present invention may now be described with reference to Figures 1 and 2. It should be understood that steps may be omitted from this process and/or, the sequence of the steps may be changed without deviating from the spirit or scope of the invention. A first step desirable in some applications is to pre-lubricate and pre-dilate the urethra of the patient. It may also be desirable to apply a lubricant to the outer surfaces of intraurethral device 20. A force F may then be applied to distal end 46 of valve housing 40 so that it assumes insertion position 100 as shown in Figure 1.

Generally conical distal tip 102 comprising distal members 50 is inserted into the patients urethra. The remainder of intraurethral device 20 including sleeve 22 may then be urged into the urethra until proximal retainer 28 contacts the urethral labia. Having placed intraurethral device 20 in this position, the application of force F on valve housing 40 may be discontinued. When the application of force F on valve housing 40 is discontinued, distal members 50 assume position 200 as shown in Figure 2. When intraurethral device 20 assumes retention position 200, distal members 50 serve to prevent proximal motion of sleeve 22 out of the patient by contacting the bladder floor. Figure 7 is a plan view of intraurethral device 20 disposed in the urethra of a patient. In this figure, the urethra and bladder are shown in cross-section. In Figure 7, intraurethral device 20 is shown after distal members 50 have been allowed to assume deployed position 200.

Figure 3 is a perspective view of an assembly including an intraurethral device 20 and an applicator 400. Intra-urethral device 20 includes a sleeve 22 shown in partial cross section. Sleeve 22 includes a distal portion 26 and a proximal portion 24. A proximal retainer 28 is fixed to proximal portion 24 of sleeve 22. A ring 64 is fixed to distal portion of 26 of sleeve 22. Sleeve 22 includes a sleeve wall 32 defining a central lumen 30. A valve housing 40 is disposed in lumen 30 of sleeve 22.

Intraurethral device 20 also includes a plurality of distal members 50 which are shown in cross-section in Figure 3. Distal members 50 each include a proximal portion 54 and a distal portion 56. Proximal portions 54 of distal members 50 are fixed to ring 64 by elastomer hinges 62 (not shown). Elastomer hinges 62 may be deformed to allow distal members 50 to assume positions other than the position shown in Figure 3. Intraurethral device 20 includes an actuating means 300 which may selectively apply force to proximal portions 54 of distal members 50 causing the angular position of distal members 50 to change. In the embodiment of Figure 3, actuating means 300 includes a spring 304 which is biased to act distally upon proximal portions 54 of distal members 50.

Applicator 400 includes a housing 402 having a distal end 406 and a proximal portion 404. Proximal portion 404 of housing 402 includes a housing flange 408 having a stop 418. An applicator tip 410 is fixed to distal end 406 of housing 402. Housing 402 further includes a wall 432 defining a lumen 430.

An applicator rod 440 is disposed in lumen 430 of housing 402. Applicator rod 440 includes a distal end 446 and a proximal end 444. One or more keys 450 is disposed proximate distal end 446 of applicator rod 440. An actuating pad 446 is fixed to proximal end 444 of applicator rod 440.

Applicator rod 440 also includes a first rod flange 452 and a second rod flange 454. The travel of applicator rod 440 in a proximal direction is limited by stop 418 of housing flange 408. As shown in Figure 3, stop 418 of housing flange 408 is adapted to make contact with second rod flange 454 of applicator rod 440. Applicator 400 includes an applicator spring 460 disposed in lumen 430 of housing 402. A proximal end 464 of spring 460 seats againsi- first rod flange 452 of applicator rod 440. A distal end 466 of applicator spring 460 seats against applicator tip 410 of applicator 400. Applicator spring 460 is positioned between first rod flange 452 and applicator tip 410 so that it urges applicator rod 440 in a proximal direction.

As described above, intraurethral device 20 includes a spring 304 which is biased to act distally upon proximal portions 54 of distal members 50. In the embodiment of Figure 3, applicator rod 440 and spring 460 are acting proximally upon proximal end 46 of valve housing 40. The force applied to proximal end 46 of valve housing 40 is sufficient to compress spring 304 of intraurethral device 20. In this manner applicator 400 may be utilized to selectively place distal members 50 in the position shown in Figure 3. In the embodiment of Figure 3, distal end 446 of applicator rod 440 is adapted to be inserted into a proximal orifice 48 of valve housing 40. The elements of applicator rod 440 and valve housing 40 are best shown in Figures 4 and 5. Figure 4 is a perspective view of applicator rod 440, and Figure 5 is a cross-sectional perspective view of valve housing 40. As shown in Figure 4, applicator rod 440 includes a distal end 446 and a proximal end 444. As described previously, applicator rod 440 includes a first rod flange 452, and a second rod flange 454. Keys 450 are disposed proximate distal end 446 of applicator rod 440. Keys 450 are adapted to selectively engage the proximal portion of valve housing 40. As shown in Figure 5, valve housing 40 includes a proximal portion 46 and a distal portion 42. Proximal portion 46 of valve housing 40 includes a proximal orifice 48, a shoulder 49, and one or more key slots 45. Key slots 45 are adapted to act as a passageway for keys 450 of applicator rod 440 when distal end 446 is inserted into proximal orifice 48 of valve housing 40. Once distal end 446 of applicator rod 440 is disposed inside valve housing 40, applicator rod 440 may be rotated so that keys 450 are no longer in alignment with key slots 45. With keys 450 in a misaligned position relative to key slots 45, keys 450 may apply a proximal force upon shoulder 49. Valve housing 40 of Figure 5 also includes a plurality of recesses 44 proximate distal portion 42 which are adapted to receive crown 310. Crown 310 is best shown in Figure 6.

Figure 6 is a perspective view of one embodiment of a crown in accordance with the present invention. As shown in Figure 6, crown 310 includes a base 312 and an engaging member 314. As described previously, valve housing

40 includes a plurality of recesses 44 which are adapted to receive base 312 and/or engaging member 314 of crown 310.

A method of positioning intraurethral device 20 into a urethra utilizing applicator 400 may now be described with reference to Figures 4-7. A first step desirable in some applications is to pre- lubricate and pre-dilate the urethra of the patient. In many cases it is desirable to apply a lubricant to the exterior surfaces of intraurethral device 20 prior to insertion.

The use of applicator 400 typically begins with the steps of urging applicator rod 440 in a distal direction and inserting distal end 446 of applicator rod 440 into proximal proximal orifice 33 of sleeve 22. In a presently preferred embodiment of the present invention, housing flange 408 is adapted to receive two of the physicians fingers and pad 446 is adapted to receive the physicians thumb. In this presently preferred embodiment, the thumb is used to apply pressure to pad 446, urging applicator rod 440 in a distal direction relative to applicator housing 402. Applying pressure to pad 446 also has the effect of compressing applicator spring 460. This presently preferred embodiment allows for simple, one handed operation of applicator 400. Once distal end 446 of applicator rod 440 is inserted into proximal orifice 33 of sleeve 22, applicator rod 440 may be rotated until keys 450 are aligned with key slots 45. Distal end 446 of applicator rod 440 may then be inserted through orifice 48 of valve housing 40. Once distal end 446 of applicator rod 440 is disposed inside valve housing 40, applicator rod 440 may be rotated so that keys 450 are no longer in alignment with key slots 45. With keys 45 in a misaligned position relative to key slots 45, keys 450 may apply a proximal force upon shoulder 49. In this manner, distal end 446 of applicator rod 440 is selectively linked to proximal portion 46 of valve housing 40. The connection formed between applicator rod 440 and valve housing 40 may be generally referred to as a bayonet connection. Those of skill in the art will appreciate that other methods of selectively linking applicator rod 440 to valve housing 40 may be used with out deviating from the spirit or scope of the present invention.

Once applicator rod 440 is placed in the desired position, the pressure applied to pad 446 is release, allowing applicator spring 460 to expand. When applicator spring 460 expands it will urge valve housing 40 in a proximal direction compressing spring 304 of intraurethral device 20. When spring 304 of intraurethral device 20 is compressed, distal members 50 are free to assume insertion position 100 as shown in Figure 1. When distal members 50 assume insertion position 100, they form a generally conical tip 102.

Distal tip 102 may now be inserted into the urethra. The generally conical shape of distal tip 102 allows for easy insertion. Once distal tip 102 has entered the urethra, the remainder of intraurethral device 20 may be urged into the urethra until proximal retainer 28 is disposed proximate the urethral labia.

Having placed intraurethral device 20 into the urethra, applicator 400 may now be disengaged from intraurethral device 20. This may be accomplished by applying pressure to pad 446 causing applicator rod 440 to move in a distal direction. Applicator rod 440 may then be rotated so that keys 450 are in alignment with key slots 45. The pressure applied to pad 446 is then release, allowing applicator spring 460 to expand. As applicator spring 460 expands it will pull applicator rod 440 in a proximal direction, causing keys 450 to pass through key slots 45. Once keys 450 have passed through key slots 45, applicator 400 may be moved in a proximal direction away from intraurethral device 20.

When applicator 400 is removed, spring 304 of intraurethral device 20 will be free to expand causing distal members 50 to assume deployed position 200 as shown in Figure 2. When intraurethral device 20 assumes position 200, distal members 50 serve to prevent proximal motion of intraurethral device 20 out of the patient by contacting the bladder floor. Distal motion of intraurethral device 20 into the patient is prohibited by proximal retainer 28.

When intraurethral device 20 assumes deployed position 200, distal members 50 serve to prevent proximal motion of intraurethral device 20 out of the patient by contacting the bladder floor. Distal motion of sleeve 22 into the patient is prohibited by proximal retainer 28 which contacts the labia of the urethra. In this manner, intraurethral device 20 is held within the urethra by distal members 50 and proximal retainer 28 acting at opposite ends of the urethra. Having thus described the preferred embodiments of the present invention, those of skill in the art will readily appreciate that yet other embodiments may be made and used within the scope of the claims hereto attached.

Numerous advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Claims

What is claimed is:

1. An intraurethral device to treat female urinary incontinence, comprising: a sleeve having a distal end; a plurality of distal members disposed at the distal end of the sleeve, each having a proximal portion; the proximal portion of each distal member being fixed to the distal end of the sleeve by a linking member; and a means for urging the distal members from a first position to a second position.

2. A female intraurethral device as recited in claim 1, wherein the linking member is comprised of a flexible material.

3. A female intraurethral device as recited in claim 1, wherein the linking member is comprised of an elastomeric material.

4. A female intraurethral device as recited in claim 1, wherein the means for urging the distal members from a first position to a second position includes a spring.

5. A female intraurethral device as recited in claim 1, wherein the distal members form a generally conical distal tip when disposed in the first position.

6. A female intraurethral device as recited in claim 1, wherein the distal members extend radially away from the sleeve when disposed in the second position.

7. A female intraurethral device as recited in claim 1, wherein the distal members extend outwardly when disposed in the second position.

8. A female intraurethral sleeve as recited in claim 1, wherein the linking members are biased to place the distal members in the first position.

9. A female intraurethral sleeve as recited in claim 1, wherein the linking members are biased to place the distal members in the first position.

10. A female intraurethral sleeve as recited in claim 1, wherein the linking members are biased to place the distal members in the first position and the means for urging the distal members from a first position to a second position is biased to place the distal members in the second position

11. A female intraurethral sleeve as recited in claim 1, wherein the distal members and the linking members are formed from the same material.

12. A female intraurethral device as recited in claim 1, wherein a flow control valve is disposed within the sleeve lumen.

13. An applicator for an intraurethral device to treat female urinary incontinence, comprising: a housing having a distal end, a proximal end, and a lumen extending therebetween; a distal tip member fixed to the distal end of the housing; a rod disposed in the lumen of the housing; the rod including a distal end, a proximal end, and at least one flange; a means for selectively connecting the rod to a proximal end of the intraurethral device disposed at the distal end of the rod; and a spring having a proximal end and a distal end; wherein the spring is disposed in the lumen of the housing, the distal end of the spring being seated on the distal tip member and the proximal end of the spring being seated on the flange of the rod.

14. The applicator of claim 13, wherein the means for selectively connecting with the intraurethral device is a bayonet connection.

15. A method for treating female urinary incontinence comprising: providing an intraurethral device to treat female urinary incontinence, comprising: a sleeve having a distal end; a plurality of distal members disposed at the distal end of the sleeve, each having a proximal portion; the proximal portion of each distal member being fixed to the distal end of the sleeve by a linking member; and a means for selectively positioning the distal members in a first position and a second position. selectively positioning the distal members in a first position; inserting the distal members of the intraurethral device into a female urethra; urging the sleeve of the intraurethral device into the female urethra; and selectively positioning the distal members in a second position.

16. The method of claim 15, wherein the distal members form a generally conical distal tip when disposed in the first position.

17. The method of claim 15, wherein the distal members extend radially away from the sleeve when disposed in the second position.

18. The method of claim 15, wherein the distal members extend outwardly when disposed in the second position.