HK40005911B - Incontinence device - Google Patents

Description

Urinary incontinence device

Cross Reference to Related Applications

The present application claims benefit of U.S. patent application serial No. 62/366,468 entitled "STRESS INCONTINENCE DEVICE (STRESS INCONTINENCE DEVICE)" filed 2016, 7, 25.

Technical Field

The present invention relates generally to urinary incontinence devices.

Background

By way of background, it is well understood that the female pelvic region includes portions of the female reproductive system, female gastrointestinal system, and female urinary system. The female pelvic region is shown in fig. 1 and includes the vagina 200, cervix 210, uterus 212, urethra 208, bladder 214, and pubic symphysis 216. The vagina 200 includes an introitus 218 that exits the body and contains a vaginal canal 202 that extends from the introitus 218 to the cervix 210. The length of the vaginal cavity 202 is in the range of about 4 to about 6 inches in most women. The cervix 210 is the entrance to the uterus and is located between the upper portion of the vaginal cavity 202 and the uterus 212. The vaginal cavity 202 has an inner periphery 220.

The inner perimeter 220 of the vaginal canal 202 is formed by a right sidewall 222, a left sidewall (not shown), an anterior wall 206, and a posterior wall 204. The four walls encompass the entire 360 degree inner periphery 220. The anterior wall 206 is positioned closest to the urethra 208, and the urethra 208 is positioned between the pubic symphysis 216 and the vagina 200.

The vaginal cavity 202 is generally divided into three approximately equal sections, each representing approximately one-third of the total length. Each section is approximately 2 inches in length. The lower third 236 of the vaginal canal 202 is the most important part for alleviating female urinary incontinence because it is adjacent to the urethra 208. The lower third 236 of the vaginal canal 202 is a location that is affected by the placement of a vaginal insertion device (which can alleviate conditions of female urinary incontinence) regardless of where the majority of the device is located in the vagina 202 after insertion. In an upright woman, the middle third 237 of the vaginal cavity 202 is horizontally offset relative to the lower third 236 of the vaginal cavity 202, wherein the lower third 236 of the vaginal cavity 202 is generally parallel to the urethra 208. The urethra 208 is located between the lower third 236 of the vaginal cavity 202 and the pubic symphysis 216, which is a bony structure located near the anterior portion of the human torso and may be referred to as the bladder neck region.

The urethra 208 (also referred to as the urethral canal) is a hollow tubular structure located in front of the vaginal cavity 202. The urethra 208 extends from a first opening 226 out of the body to a second opening 228 at the lower surface of the bladder 214. The posterior urethral angle is formed where the urethra 208 enters the bladder 214. The urethra 208 of most women has a length of about 1.5 inches. The urethra 208 is used to drain urine from the body that is temporarily stored in the bladder 214. The urethra 208 has a plurality of urethral sphincters 232 positioned along its inner circumferential length. The urethral sphincter 232 is located below the opening 228 and is a ring-shaped muscle that normally keeps the urethra 208 contracted to prevent urine from passing through. Relaxation of the urethral sphincter 232 through normal physiological functions allows urine to be automatically drained from the body.

Pubococcygeus 233 originates at the pubic symphysis 216 and extends to the lower extent of the coccyx 234, with a passage in the center of the muscle through which the rectum 235, vagina 200 and urethra 208 pass. The posterior portion of the passage through the pubococcygeus muscle 233 normally provides support to the posterior portion of the urethra 208 through the rectum 235 and the soft tissue of the vagina 200, which helps keep the urethra 208 contracted to prevent passage of urine. When the pubococcygeus muscle 233 stretches due to childbirth or relaxes, typically due to the normal aging process, support to the back of the urethra 208 is reduced, and involuntary flow of urine through the urethra 208 may occur, particularly when pressure is applied to the bladder 214 during coughing or other abdominal contractions. This condition is known as stress urinary incontinence. Replacing or supplementing the support to the posterior side of the urethra 208 may help prevent urine from unintentionally flowing through the urethra 208.

Disclosure of Invention

It is therefore an object of the present invention to provide a urinary incontinence device that can be inserted into and removed from the vaginal cavity of a human user to apply pressure to the urethra. The urinary incontinence device includes a distal body member having a central core, a first arcuate arm on a first side of the central core, and a second arcuate arm on a second, opposite side of the central core. The first and second arcuate arms flex inwardly toward the central core to a first compressed position during insertion and expand outwardly away from the central core to a second use position to fill the space in the middle and upper thirds of the vaginal cavity to retain the urinary incontinence device in the vaginal cavity. The urinary incontinence device also includes a proximal pressure member extending from the body member for resilient movement relative to the body member; wherein the pressure member applies pressure to support the urethra to control urinary incontinence.

It is another object of the present invention to provide a urinary incontinence device comprising a cord attached to a first arcuate arm and a second arcuate arm for removal of the urinary incontinence device from the vaginal cavity.

It is another object of the present invention to provide a urinary incontinence device comprising an actuation mechanism comprised of a single flexible cord connected to first and second arcuate arms and a central core and pressure member such that when the cord is pulled, the arcuate arms move toward the central core to a first compressed position.

It is another object of the present invention to provide a urinary incontinence device wherein the body member is S-shaped.

It is another object of the present invention to provide a urinary incontinence device wherein the urinary incontinence device is symmetrical such that the upper or lower surface of the body member can be placed in direct contact with the posterior wall of the vaginal cavity during deployment so that the urinary incontinence device does not cause any injury to the human user if inserted upside down.

It is another object of the present invention to provide a urinary incontinence device wherein the thickness of the pressure member varies as the pressure member extends from the body member to the uncoupled second end of the pressure member.

It is another object of the present invention to provide a urinary incontinence device wherein the uncoupled second end of the pressure member further comprises projections on opposite sides thereof.

It is another object of the present invention to provide a urinary incontinence device wherein the pressure member tapers in thickness as it extends away from the body member.

Other objects and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings which illustrate certain embodiments of the invention.

Drawings

Fig. 1 is a cross-sectional view of the female pelvic region into which the present urinary incontinence device has been inserted.

Fig. 2 is a top perspective view of a urinary incontinence device.

Fig. 3 is a bottom view of the urinary incontinence device shown in fig. 2.

Fig. 4 is a side elevational view of the urinary incontinence device shown in fig. 2 in its relaxed orientation.

Fig. 5 is a side elevational view of the urinary incontinence device shown in fig. 2 in its curved orientation.

Fig. 6 is a perspective view of a urinary incontinence device according to an alternative embodiment.

Fig. 7 is a bottom view of the urinary incontinence device shown in fig. 6.

Fig. 8 is a top perspective view of an alternative embodiment of a urinary incontinence device.

Fig. 9 is a bottom view of the embodiment shown in fig. 8 with the cord removed.

Fig. 10 is a top view of the embodiment shown in fig. 8 with the cord removed.

Fig. 11 is a side view of the embodiment shown in fig. 8 with the cord removed.

Detailed Description

Detailed embodiments of the present invention are disclosed herein. However, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limiting, but merely as the basis for teaching one skilled in the art how to make and/or use the invention.

Referring to fig. 1-5, and in view of the female pelvic anatomy described above with reference to fig. 1, the present stress urinary incontinence device 10 is adapted to be positioned such that the second end 10b is located in the plane of the pubococcygeus 233, while the remainder of the stress urinary incontinence device 10 is located in the middle and upper portions of the vaginal cavity 202.

Stress urinary incontinence device 10 comprises: a distal body member 12 shaped and dimensioned for positioning against a posterior wall 204 of the vaginal cavity 202; and a proximal pressure member 14 extending from the body member 12 for movement relative to the body member 12 such that the pressure member 14 can be used to apply support to the anterior wall 206 of the lower third 236 of the vaginal cavity 202 in the approximate plane of the pubococcygeus 233, and ultimately to the urethra 208 to control urinary incontinence. Specifically, once the stress urinary incontinence device 10 is properly positioned within the vaginal cavity 202, the pressure member 14 exerts pressure on the anterior wall 206 of the vaginal cavity 202, and ultimately on the urethra 208, due to the anatomical curvature and inherent resiliency of the stress urinary incontinence device 10 to control urinary incontinence. Because of the resiliency of the pressure member 14 and the anatomical shape of the vaginal cavity 202 of an upright woman, the pressure member 14 exhibits a spring-like effect due to the variable thickness of the pressure member 14 as it extends toward the second end 10b of the stress urinary incontinence device, resulting in the application of pressure on the urethra 208. According to a preferred embodiment, stress urinary incontinence device 10 is constructed of a flexible, biocompatible polymer or elastomeric material, such as a polyolefin, acetate, silicone, polyurethane, ABS, or various thermoplastic elastomers, and/or combinations of materials that generate the required spring-like pressure to support the urethra.

The body member 12 is located at the first end 10a of the stress urinary incontinence device 10 and the pressure member 14 is located at the second end 10b of the stress urinary incontinence device 10. The body member 12 is substantially flat along its upper and lower surfaces 16, 18 such that the upper surface 16 lies in a first plane and the lower surface 18 lies in a second plane substantially parallel to the first plane. It should be understood that although the body member 12 is described as being substantially flat, the surface of the body member may be contoured to allow consistent wall thicknesses for injection molding, but the upper and lower surfaces generally lie in two parallel planes. Most importantly, in accordance with the present invention, the central core 20 is configured to remain generally straight during use, while the pressure members 14 are bent. As will be appreciated based on the disclosure below, the body member 12 is configured to have a substantially symmetrical configuration such that either the upper surface 16 or the lower surface 18 of the body member 12 can be placed in direct contact with the posterior wall 204 of the vaginal cavity 202 during deployment without adverse effects.

The body member 12 is basically comprised of three elements, namely, a central core 20, a first arcuate arm 22 and a second arcuate arm 24. The central core 20 is an elongated member that includes a first end 26 and a second end 28. The central core 20 also includes an upper surface 30, a lower surface 32, first and second lateral sidewalls 34, 36 extending between the upper and lower surfaces 30, 32, and a first end wall 38.

The first arcuate arm 22 includes a first end 42 fixed to the first end 26 of the central core 20 and a second end 44 located adjacent the second end 28 of the central core 20. The first arcuate arm 22 extends through an arc of approximately 90 to 140 degrees, preferably 125 degrees. The first arcuate arm 22 includes a circular cross-sectional profile as the first arcuate arm 22 extends from the first end 42 thereof toward the second end 44 of the first arcuate arm 22. Although a circular cross-sectional profile is disclosed herein, it should be understood that the first arcuate arm may have an oval or rectangular cross-section.

The first arcuate arm 22 is provided with a rounded protrusion 46 at its second end 44. The circular projection 46 includes an upper surface 48 and a lower surface 50 that are aligned with the upper surface 30 and the lower surface 32, respectively, of the central core 20. The circular boss 46 also includes a curved outer wall 52 extending between its upper surface 48 and its lower surface 50.

The second arcuate arm 24 includes a first end 54 secured to the first end 26 of the central core 20 and a second end 56 positioned adjacent the second end 28 of the central core 20. The second arcuate arm 24 extends through an arc of approximately 90 to 140 degrees, preferably 125 degrees. The second arcuate arm 24 includes a circular cross-sectional profile as it extends from its first end 54 toward a second end 56 of the second arcuate arm 24. Like the first arcuate arm 22, the second arcuate arm 24 may also have an oval or rectangular cross-section.

The second arcuate arm 24 is provided with a rounded projection 58 at its second end 56. The circular projection 58 includes an upper surface 60 and a lower surface 62 that are aligned with the upper surface 30 and the lower surface 32, respectively, of the central core 20. The circular boss 58 also includes a curved outer wall 64 extending between the upper and lower surfaces 60, 62 thereof. Although circular projections at the ends of the first and second arcuate arms are disclosed, the projections may take on a variety of shapes, so long as they have smooth rounded edges so as not to cause discomfort.

According to an alternative embodiment shown in fig. 6 and 7, the orientation of the second arcuate arm 24' may be changed (while the first arcuate arm 22' is still as described above) such that the second arcuate arm 24' is connected at the second end 28' of the central core 20' and extends to the first end 26' of the central core 20 '. Specifically, the second arcuate arm 24' includes a first end 54' secured to the second end 28' of the central core 20', and a second end 56' located adjacent the first end 26' of the central core 20 '. The arcuate shape of the first and second arcuate arms 22', 24' forms a substantially S-shaped body member.

In addition to reorienting the second arcuate arm 24', this embodiment also includes a groove 21' along the second lateral sidewall 36 'at the first end of the central core 20'. The recess 21' is shaped and dimensioned to receive the rounded protrusion 58' at the second end 56' of the second arcuate arm 24' when the second arcuate arm 24' is compressed toward the central core 20 for insertion of the stress urinary incontinence device 10 as described below.

The arcuate shape of the first and second arcuate arms 22, 24 allows the first and second arcuate arms 22, 24 to flex relative to the central core 20 during insertion (or retrieval) of the stress urinary incontinence device 10 into (i.e., the inserted and retrieved state of the stress urinary incontinence device 10) and then expand to fill the space in the middle and upper thirds 237, 238 of the vaginal cavity 202 in order to retain the device 10 in the vagina 200 (i.e., the deployed state of the stress urinary incontinence device 10). The first and second arcuate arms 22, 24 are similarly curved to allow removal from the vagina 200 in a folded condition.

As described above, stress urinary incontinence device 10 includes pressure member 14 extending from body member 12 in a manner that allows controlled bending of pressure member 14 relative to body member 12 for applying support to anterior wall 206 of vaginal cavity 202 and ultimately urethra 208 to control urinary incontinence, which replaces the loss of support due to stretching of the passage through pubococcygeus 233. While bending of the pressure member 14 relative to the body member 12 is achieved in accordance with the present invention, the stress urinary incontinence device 10 is substantially flat when in its relaxed configuration, and will assume a bent configuration when in use as shown in fig. 1. The ability to flex provides the inherent bias necessary to provide support along the anterior wall 206 of the vaginal cavity 202 (i.e., the stored energy resulting from the resiliency of the pressure member 14).

The pressure member 14 is an elongated member 66 including a first end 68 coupled with the second end 28 of the central core 20 and an uncoupled second end 70. The elongated member 66 also includes an upper surface 72, a lower surface 74, first and second lateral side walls 76, 78 extending between the upper and lower surfaces 72, 74, and an end wall 79 at the second end 70.

The first end 68 of the pressure member 14 is secured to the second end 70 of the central core 20. A bending point is defined at the juncture of the central core 20 and the pressure member 14 from which the pressure member 14 bends along its length in use, allowing relative movement between the body member 12 and the pressure member 14 to be achieved in a manner that creates the inherent bias of the stress urinary incontinence device 10 required in accordance with the present invention. Because the body member 12 is positioned on the posterior wall 204 of the vaginal cavity 202, the pressure member 14 begins to flex at the junction of the central core 20 and the pressure member 14 creating relative motion such that the second end 70 of the pressure member 14 moves into contact with the anterior wall 206 of the vaginal cavity 202.

The shape of the pressure member 14 allows the pressure to be applied in a controlled manner. Specifically, the second end 68 of the pressure member 14 is provided with elongated projections 80, 82 along its upper and lower surfaces 72, 74. The upper protrusion 80 extends a desired distance above the upper surface 72 of the pressure member 14, while the lower protrusion 82 extends a desired distance above the lower surface 74 of the pressure member 14.

The upper and lower projections 80, 82 are similarly shaped. The projections each extend from a first side wall 76 to a second side wall 78 of the pressure member 14 at a location adjacent the second end 70 of the pressure member 14. Although the side walls 84, 86 of the upper and lower projections 80, 82 are substantially flat, the surface extending between the side walls 84, 86 has a semi-circular profile when viewed in cross-section taken along the longitudinal axis of the pressure member 14 (i.e., the axis extending between the first and second ends 68, 70 of the pressure member 14). It should be understood that although preferred projections are shown in the figures, the extent to which the projections extend outwardly may vary depending on the particular anatomical needs.

It should also be appreciated that the thickness of the pressure member 14 preferably tapers as it extends from the first end 68 to the second end 70 to have the strength to apply pressure to the urethra 208. The taper may be symmetrical or asymmetrical to apply the desired pressure.

The stress urinary incontinence device 10 is designed such that if inserted upside down, the stress urinary incontinence device 10 does not cause any injury to the user. Specifically, because the stress urinary incontinence device 10 is symmetrical (when unstressed as shown in fig. 4) to the general plane of the device (i.e., the plane between the upper and lower surfaces of the stress urinary incontinence device 10), the device will react and function identically regardless of which side is up; i.e. without a top or bottom. With this in mind, it should be understood that throughout this disclosure relative terms such as upper, lower, etc., are used solely for reference to the various drawings employed to disclose the invention.

The stress urinary incontinence device 10 is further provided with an actuating mechanism 88 for controlling the bending of the first and second arcuate arms 22, 24 relative to the central core 20 so as to allow the first and second arcuate arms 22, 24 to be pulled towards the central core 20 to reduce the profile of the stress urinary incontinence device 10 so that it is easier to pass through the vaginal opening. The actuating mechanism 88 is comprised of a single flexible cord 90 connected to the first and second arcuate arms 22, 24 and the central core 20 and pressure member 14. The cable 90 includes a first end 92 secured to a central location along the length of the first arcuate arm 22 and a second end 94 secured to a central location along the length of the second arcuate arm 24. The remainder of the cable 90 passes through various passages formed in the central core 20 and the pressure member 14 to form an annular portion 96 (i.e., the central section of the cable 90 between the first and second ends 92, 94), which annular portion 96 can be manipulated by a user to controllably move the first and second arcuate arms 22, 24.

The central core 20 is provided with a first transverse channel 98 extending between the first transverse sidewall 34 of the central core 20 and the second end 28 of the central core 20, wherein the first transverse channel 98 transitions into a first guide slot 100 formed in the upper surface 72 of the pressure member 14. The central core 20 is further provided with a second transverse channel 102 extending between the second transverse sidewall 36 of the central core 20 and the second end 28 of the central core 20, wherein the second transverse channel 102 transitions into a second guide slot 104 formed in the upper surface 72 of the pressure member 14. The first and second transverse channels 98, 102 are provided with entrances 106, 108 to allow viewing of the tether 90 as it passes therethrough.

Considering the cord 90 as extending from its first end 92 to its second end 94, the first end 92 is secured to a central portion along the inner surface of the first arcuate arm 22. The cord 90 then extends through the aperture 110 formed in the first sidewall 34 and into the first transverse passageway 98. The cord 90 exits the first transverse channel 98 at the aperture 111 in the second end 28 of the central core 20 and extends into the first channel 100. Upon exiting the first channel 100, the cord 90 forms a loop 96 and then extends into the second channel 104. After passing through the second channel 104, the cord 90 extends through the aperture 112 formed in the second end 28 of the central core 20 and into the second transverse passage 102. The cord 90 then extends through the second transverse channel 102 until it exits the second transverse channel 102 at the hole 114 formed in the second transverse sidewall 36 of the central core 20. The cord 90 extends from the second lateral side wall 36 to a second end 94 thereof, the second end 94 being secured to the inner surface of the second arcuate arm 24.

According to another embodiment of the invention as shown in fig. 8 and 9, and as with the previously described embodiments, this alternative embodiment provides a urinary incontinence device 410 adapted to be positioned such that the second end 410b is located in the plane of the pubococcygeus 233, while the remainder of the urinary incontinence device 410 is located in the middle and upper portions of the vaginal cavity 202.

Urinary incontinence device 410 includes: a distal body member 412 shaped and dimensioned for positioning against the posterior wall 204 of the vaginal cavity 202; and a proximal pressure member 414 extending from the body member 412 for movement relative to the body member 412 such that the pressure member 414 can be used to apply support to the anterior wall 206 of the lower third 236 of the vaginal cavity 202 in the approximate plane of the pubococcygeus 233, and ultimately to the urethra 208 to control urinary incontinence. In particular, once the urinary incontinence device 410 is properly positioned within the vaginal cavity 202, the pressure member 414 exerts pressure on the anterior wall 206 of the vaginal cavity 202 and ultimately on the urethra 208 to control urinary incontinence due to the anatomical curvature and inherent resiliency of the urinary incontinence device 410. Due to the resiliency of the pressure member 414 and the anatomical shape of the upright female vaginal cavity 202, the pressure member 414 exhibits a spring-like effect, since the pressure member 414 may vary in thickness as it extends toward the second end 410b of the stress urinary incontinence device, which results in a pressure being exerted on the urethra 208. According to a preferred embodiment, urinary incontinence device 410 is constructed of a flexible, biocompatible polymer or elastomeric material, such as polyolefin, acetate, silicone, polyurethane, ABS, or various thermoplastic elastomers and/or combinations of materials that generate the required spring-like pressure to support the urethra.

Body member 412 is located at a first end 410a of urinary incontinence device 410, and pressure member 414 is located at a second end 410b of urinary incontinence device 410 b. The body member 412 is substantially flat such that its upper surface 416 lies primarily in a first plane and its lower surface 418 lies primarily in a second plane substantially parallel to the first plane. It should be understood that although the body member 412 is depicted as being substantially flat, the surface of the body member may be contoured to allow the desired curvature for insertion and retrieval from the vaginal canal of a human user. Most importantly, in accordance with the present invention, the central core 420 is configured to remain substantially straight while the pressure members 414 are bent. As will be appreciated based on the disclosure below, the body member 412 is configured such that either the upper surface 416 or the lower surface 418 of the body member 412 can be placed in direct contact with the back wall 204 of the vaginal cavity 202 during deployment without adverse effects.

The body member 412 is generally composed of three elements, namely, a central core 420, a first arcuate arm 422 and a second arcuate arm 424. The central core 420 is an elongated member that includes a first end 426 and a second end 428. The central core 420 further includes an upper surface 430, a lower surface 432, first and second lateral sidewalls 434, 436 extending between the upper and lower surfaces 430, 432, and a first end wall 438. As will be appreciated based on the disclosure below, the central core 420 includes a curved configuration as it extends from its first end 426 to its second end 428. This curved configuration allows the first and second arcuate arms 422, 424 to achieve a desired position as the first and second arcuate arms 422, 424 extend from the first end 426 of the central core 420.

The first arcuate arm 422 includes a first end 442 and a second end 444, wherein the first end 442 is secured to the first end 426 of the central core 420 and the second end 444 is located adjacent the first end 426 of the central core 420 but on an opposite side of the central core 420 from where the first end 442 of the first arcuate arm 422 extends. The first arcuate arm 422 extends from the first end 426 of the central core 420 in a counterclockwise direction away from the first end 426 and the second end 428 of the central core 420 to form a loop across the first end 426 of the central core 420, wherein the first arcuate arm 422 terminates adjacent the second end 444 near the first end 426 of the central core 420. The first arcuate arm 422 may thus be considered to be located on a first side of the central core 420. According to a preferred embodiment, the first arcuate arm 422 extends approximately a 350 ° loop.

The first arcuate arm 422 includes a rectangular cross-sectional profile as the first arcuate arm 422 extends from its first end 442 to the second end 444 of the first arcuate arm 422. Although a rectangular cross-sectional profile is disclosed herein, it should be understood that the first arcuate arm may have an oval or circular cross-section.

The first arcuate arm 422 is provided with a rounded projection 446 at its second end 444. The circular projection 446 includes an upper surface 448 and a lower surface 450. Holes 452 are formed in the circular projection 446 and extend from the upper surface 448 to the lower surface 450.

The second arcuate arm 424 includes a first end 454 and a second end 456, wherein the first end 454 is secured to the first end 426 of the central core 420, and the second end 456 is located adjacent the first end 426 of the central core 420 and the first end 442 of the first arcuate arm 422, and on the same side of the central core 420 from which the first end 454 of the second arcuate arm 424 extends. That is, when viewed as in fig. 11, the second arcuate arm 424 extends from the first end 426 of the central core 420 in a counterclockwise direction away from the first end 426 and toward the second end 428 of the central core 420 to form a loop positioned along the curvature of the central core 420 for a portion of its section, with the second arcuate arm 424 terminating at its second end 456 located near the first end 426 of the central core 420. The second arcuate arm 424 may thus be considered to be located on a second side of the central core 420, which is opposite the first side on which the first arcuate arm 422 is located. According to a preferred embodiment, the second arcuate arm 424 extends approximately a 350 loop. Based on the arcuate orientation of the first and second arcuate arms 422, 424 and their connection to each other via the central core 420, a substantially S-shaped body is formed.

The second arcuate arm 424 includes a rectangular cross-sectional profile as the second arcuate arm 424 extends from a first end 454 to a second end 456 of the second arcuate arm 424. Although a rectangular cross-sectional profile is disclosed herein, it should be understood that the first arcuate arm may have an oval or circular cross-section.

The second arcuate arm 424 is provided with a rounded projection 458 at its second end 456. The circular projection 458 includes an upper surface 460 and a lower surface 462. The aperture 454 is formed in the circular projection 458 and extends from the upper surface 460 to the lower surface 462.

As with the previous embodiments, the arcuate shape of the first and second arcuate arms 422, 424 allows the first and second arcuate arms 422, 424 to flex relative to the central core 420 during insertion (or retrieval) of the urinary incontinence device 410 into (i.e., insertion and retrieval states of the urinary incontinence device 410) and then expand to fill the space in the middle and upper thirds 237, 238 of the vaginal cavity 202 in order to retain the urinary incontinence device 410 in the vagina 200 (i.e., the deployed state of the urinary incontinence device 410). The first and second arcuate arms 422, 424 likewise bend to allow removal from the vagina 200 in a folded condition.

The urinary incontinence device 410 includes a pressure member 414, the pressure member 414 extending from the body member 412 in a manner that allows controlled bending of the pressure member 414 relative to the body member 412 for applying support to the anterior wall 206 of the vaginal canal 202 and ultimately to the urethra 208 to control urinary incontinence, which replaces the loss of support due to stretching of the passage through the pubococcygeus muscle 233. While bending of the pressure member 414 relative to the body member 412 is achieved in accordance with the present invention, the urinary incontinence device 410 is substantially flat when in a relaxed configuration and will assume a bent configuration in use, similar to that shown with reference to the embodiment shown in fig. 5. The ability to flex provides the inherent bias necessary to provide support along the anterior wall 206 of the vaginal cavity 202 (i.e., the stored energy created by the resiliency of the pressure member 414).

The pressure member 414 is an elongated member 466 that includes a first end 468 coupled with the second end 428 of the central core 420 and an uncoupled second end 470. The elongate member 466 also includes an upper surface 472, a lower surface 474, first and second lateral side walls 476, 478 extending between the upper and lower surfaces 472, 474, and an end wall 479 at the second end 470.

The first end 468 of the pressure member 414 is secured to the second end 428 of the central core 420. At the juncture of the central core 420 and the pressure member 414, a bending point is defined from which the pressure member 414 bends along its length in use, allowing relative movement between the body member 412 and the pressure member 414 to be achieved in a manner that creates the inherent bias of the urinary incontinence device 410 required in accordance with the present invention. Because the body member 412 is located on the posterior wall 204 of the vaginal canal 202, the bending of the pressure member 414, which begins at the junction of the central core 420 and the pressure member 414, produces relative motion such that the second end 470 of the pressure member 414 moves into contact with the anterior wall 206 of the vaginal canal 202.

The shape of the pressure member 414 allows pressure to be applied in a controlled manner. In particular, the second end 468 of the pressure member 414 is provided with elongated projections 480, 482 along its upper and lower surfaces 472, 474. The upper projection 480 extends a desired distance above the upper surface 472 of the pressure member 414, while the lower projection 482 extends a desired distance above the lower surface 474 of the pressure member 414.

The upper and lower tabs 480, 482 are similarly shaped. These protrusions each extend from the first side wall 476 to the second side wall 478 of the pressure member 414 at a location adjacent the second end 470 of the pressure member 414. Although the sidewalls 484, 486 of the upper and lower tabs 480, 482 are substantially flat, the surface extending between the sidewalls 484, 486 has a semi-circular profile when viewed in cross-section taken along the longitudinal axis of the pressure member 414 (i.e., the axis extending between the first and second ends 468, 470 of the pressure member 414). It should be understood that although preferred projections are shown in the figures, the extent to which the projections extend outwardly may vary depending on the particular anatomical needs.

It should also be appreciated that the thickness of the pressure member 414 preferably tapers as the pressure member 414 extends from the first end 468 to the second end 470 in order to have a strength to exert pressure on the urethra 208. The taper may be symmetrical or asymmetrical to apply the desired pressure.

As with the previous embodiment, the urinary incontinence device 410 is designed such that if inserted upside down, the urinary incontinence device 410 will not cause any injury to the user. The device will react and function identically, regardless of which side is up; i.e. without a top or bottom.

The urinary incontinence device 410 is further provided with an actuation mechanism 488 for controlling the bending of the first and second arcuate arms 422, 424 relative to the central core 420 so as to allow the first and second arcuate arms 422, 424 to be pulled toward the central core 420 to reduce the profile of the stress urinary incontinence device 410 for easier passage through the vaginal opening. The actuation mechanism 488 consists of a single flexible cord 490 connected to the first and second arcuate arms 422, 424 and the central core 420 and the pressure member 414. The cable 490 includes a first end 492 secured to the aperture 452 in the first arcuate arm 422 and a second end 494 secured to the aperture 464 in the second arcuate arm 424. The remainder of the cable 490 passes through various passages formed in the central core 420 and the pressure member 414 to form an annular portion 496 (i.e., a central section between the first and second ends 492, 494 of the cable 490), which annular portion 496 may be manipulated by a user to controllably move the first and second arcuate arms 422, 424.

The central core 420 is provided with a first channel (or cord guide) 498 at the first end 426 of the central core 420, and a guide channel 500 formed along the curvature of the central core 420. A second channel (or cord guide) 502 is formed at the second end 468 of the pressure member 414.

Considering that the cord 490 extends from its first end 492 to its second end 494, the first end 492 is secured to the bore 452 in the first arcuate arm 422. The rope 490 then extends through a first channel (or rope guide) 498 at the first end 426 of the central core 420, along the guide channel 500 formed along the bend of the central core 420, and into a second channel (or rope guide) 502. Upon exiting the second channel (or cord guide) 502, the cord 490 forms a loop portion 496, then extends into the second channel (or cord guide) 502, follows the guide channel 500 formed along the bend of the central core 420, passes through the first channel (or cord guide) 498, and is ultimately secured to the aperture 464 in the second arcuate arm 424.

In practice, the stress urinary incontinence device 10, 410 will be prepackaged in an insert (not shown). Although not shown, it is contemplated that the insert will simply be a "tubular structure" in which the stress urinary incontinence device 10, 410 is pulled into a pre-collapsed orientation for initial placement into the vagina. However, this device requires a plunger to "push" it out of the tube to remain in the vagina. It is also contemplated that the stress urinary incontinence device 10, 410 may be deployed within the vaginal cavity 202 by first pulling the ring portion 96, 496 such that it moves away from the pressure member 14, 414, causing the first and second arcuate arms 22, 422, 24, 424 to be pulled inward toward the central core 20, 420. While the use of the actuating mechanism 88, 488 is contemplated, it should also be understood that the first and second arcuate arms 22, 422, 24, 424 may simply flex inwardly during insertion and flex rearwardly once properly positioned. It should also be appreciated that in connection with the embodiment shown in fig. 6-9, intentional inward flexure from the actuating mechanism 88, 488 will be more important because the first arcuate arm 22', 422 may "jam" during insertion.

The stress urinary incontinence device 10, 410 can then be inserted into the vaginal canal 402 and positioned such that the inferior surface 18, 418 is in contact with the posterior wall 204 of the vaginal canal 202. The stress urinary incontinence device 10, 410 is inserted into the vagina 200 with the support member 12, 412 (i.e., the first end 10a, 410a of the stress urinary incontinence device 10, 410a) first entering the vagina 200. The pressure member 14, 414 on the proximal end (i.e., second end 10b, 410b) of the stress urinary incontinence device 10, 410 ends up in the vagina 200. The first 22, 422 and second 24, 424 arcuate arms, which compress during entry into the vagina 200, deploy deep within the vagina 200, above, but generally parallel to, the pelvic floor muscles in an upright woman. This maintains the stress urinary incontinence device 10, 410 in the vagina 200. The pressure member 14, 414 is then located deep in the vagina.

Once stress urinary incontinence device 10 is properly positioned within vaginal cavity 202, annular portions 96, 496 are released, allowing first and second arcuate arms 22, 422, 24, 424 to move outwardly away from central core 20, 420. The pressure member 14, 414 is then actuated to move into contact with the anterior wall 206 of the vaginal cavity 202 in a manner that applies pressure thereto, ultimately applying pressure to the urethra 208 to control urinary incontinence; wherein the stress urinary incontinence device 10, 410 is positioned within the vaginal canal 202 such that the pressure member 14, 414 can be used to apply pressure support to the anterior wall 206 of the lower third 236 of the vaginal canal 202, and ultimately to the urethra 208, in the approximate plane of the pubococcygeus muscle 233 to control urinary incontinence.

Specifically, the vagina 200 of an upright woman curves downward and through the pelvic floor muscles. The curvature of the vagina 200 in an upright woman, which extends in a generally downward and forward direction from the depth of the vagina, also bends the pressure member 14, 414 at the proximal end of the stress urinary incontinence device 10, 410 such that the pressure member 14, 414 falls in the plane of the pelvic floor muscles. The natural tendency of the stress urinary incontinence device 10, 410 to return to its straight condition, due to the curvature created in the stress urinary incontinence device 10, 410, causes the pressure member 14, 414 to exert a supportive force on the posterior side of the urethra 208 in a direction substantially perpendicular to the lumen of the urethra 208. This support mimics the natural support of the pelvic floor muscles, which under normal, healthy physiological conditions prevents accidental relaxation of the bladder through the urethra 208. Because the stress urinary incontinence device 10, 410 is generally symmetrical with respect to a plane between the two generally "flat" sides of the stress urinary incontinence device 10, 410, the described situation exists regardless of which of the two generally "flat" sides of the device faces forward during insertion into the vagina 200. The fit between the stress urinary incontinence device 10, 410 and the pubic symphysis 216 in the vagina 200 allows the urethra 208 to compress upon itself, thereby providing a means of alleviating involuntary urine flow from the bladder.

While preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, is intended to cover all modifications and alternate constructions falling within the spirit and scope of the invention.

Claims (7)

1. A urinary incontinence device insertable into and removable from a vaginal canal of a human user for applying pressure to the urethra, comprising:

a distal body member comprising a central core having a first end and a second end, a first arcuate arm on a first side of the central core and a second arcuate arm on an opposite second side of the central core, the first and second arcuate arms curving inwardly toward the central core during insertion to a first compressed position and expanding outwardly away from the central core to a second use position to fill the space in the middle and upper thirds of the vaginal cavity to retain the urinary incontinence device in the vaginal cavity; and

a proximal pressure member extending from the distal body member for resilient movement relative to the distal body member, the proximal pressure member includes a first end coupled to the second end of the central core and an uncoupled second end, the junction of the central core and the proximal pressure member defines a bending point from which the proximal pressure member bends, thereby allowing relative movement between the distal body member and the proximal pressure member, the proximal pressure member further comprising an upper surface, a lower surface, and first and second sidewalls extending between the upper and lower surfaces, wherein the second end of the proximal pressure member is provided with a first elongated protrusion along an upper surface and the second end of the proximal pressure member is provided with a second elongated protrusion along a lower surface;

wherein the pressure member applies pressure to support the urethra to control urinary incontinence.

2. The urinary incontinence device of claim 1, further comprising a cord attached to said first arcuate arm and said second arcuate arm for removal of said urinary incontinence device from said vaginal cavity.

3. The urinary incontinence device of claim 1, comprising an actuation mechanism comprised of a single flexible cord connected to said first and second arcuate arms and said central core and said proximal pressure member such that when said cord is pulled, said first and second arcuate arms move toward said central core to said first compressed position.

4. The urinary incontinence device of claim 1 wherein said distal body member is S-shaped.

5. The urinary incontinence device of claim 1, wherein said urinary incontinence device is symmetrical such that placement of an upper or lower surface of said distal body member in direct contact with a posterior wall of said vaginal cavity during deployment will not cause any injury to said human user.

6. The urinary incontinence device of claim 1, wherein the thickness of said proximal pressure member varies as said proximal pressure member extends from said distal body member to an uncoupled second end of said proximal pressure member.

7. The urinary incontinence device of claim 6, wherein the thickness of said proximal pressure member decreases as said proximal pressure member extends away from said distal body member.