MXPA01006167A - A urinary incontinence device and a method of making the same - Google Patents

Abstract

A urinary incontinence device is disclosed along with a method of making the device. The device includes a resilient member and a non-absorbent which at least partially encloses the resilient member. The non-absorbent and the resilient member are formed into an elongated softwind having a first end and a second end. The softwind is folded upon itself such that the first and second ends are aligned adjacent to one another and the softwind contains at least two folds therebetween. The resilient member extends between at least two of the folds. The softwind is then compressed into an elongated pledget having an insertion end and a trailing end with the resilient member located at least in the insertion end. The resilient member is capable of expanding at least a portion of the pledget to provide a supportive backdrop for a woman's urethra when inserted into a woman's vagina. The method includes the steps of enclosing the resilient member by the non-absorbent, folding the two materials to form a softwind, folding the softwind into a generally M-shape configuration and then compressing the softwind into an elongated pledget.

Description

A DEVICE FOR URINARY INCONTINENCE AND A METHOD TO DO THE SAME FIELD OF INTAKE This invention relates to a device for urinary incontinence and a method for making the device More specifically, this invention relates to a device for non-absorbent urinary incontinence which is designed to be placed in the vagina of a woman to provide a support to the urethra of the woman to avoid the involuntary loss of urine commonly associated with urinary incontinence under tension.

BACKGROUND OF THE INVENTION Some women, especially women who have given birth to one or more children, and older women, may experience incidents of involuntary urine loss due to stress urinary incontinence or incontinence due to urgency and tension combined. A sneeze or cough may increase intra-abdominal pressure by hitting a person's bladder and causing involuntary release of urine. The frequency and severity of such urine loss may increase as the muscles and tissues near the myofascial area become weaker. uretrovaginal It has also been recognized that the urinary sphincter muscle, which is located at the upper end of the urethra adjacent to the bladder, works to seal the passage of urine from the bladder to the urethra when it has a round circular cross-sectional configuration. . However, when this duct is distorted in a cross-sectional configuration that has more elliptical or oval appearance, the sphincter muscle can not close properly and, therefore, the tendency to loss of involuntary urine increases.

As the female population of the world ages, there is a need that is always increasing from a n surgical procedure to reduce involuntary urine loss commonly associated with "stress urinary incontinence" Currently, there are a number of products available for this purpose. Essentially, all of these products can only be purchased with a prescription and these require that they be physically inserted and / or adjusted by a doctor or by a nurse practitioner in order to function properly. Currently, there are no products commercially available without a prescription, for avoid the involuntary loss of urine for tension urinary incontinence.

In view of the lack of commercially available non-prescription urinary incontinence devices, it has been recognized that there is a need for a device for urinary incontinence which can be purchased without a prescription. There is also a need for a device for urinary incontinence which is easier to use and can be handled by the consumer without the intervention of a practicing physician. In addition, there is a need for a device for urinary incontinence which is easy for women to insert and remove from their bodies, which is more comfortable to use and which provides a physiological and realistic assurance that it is capable of functioning properly. for an extended period of time.

SYNTHESIS OF THE INVENTION Briefly, this invention relates to a device for urinary incontinence and a method for doing the same. The device includes an elastic and non-absorbent member which at least partially encloses the elastic member. The non-absorbent and the elastic member are formed in an elongated soft wind having a first end and a second end. The gentle wind is bent over itself so that the first and second ends are aligned on one side of each other and the gentle wind contains at least two bends between them. The bending of the gentle wind gives it a generally M-shaped configuration. The gentle wind is then compressed into an elongated applicator having an insertion extremity and a tail end with the elastic member located at least at the insertion end. The elastic member is capable of expanding at least a portion of the applicator to provide support for the female urethra when the applicator is properly inserted into the vagina of a woman.

The method for making a urinary incotinence device includes the steps of cutting an absorbent n in a configuration having a central longitudinal axis. Align an elastic member adjacent to the central longitudinal ej of the non-absorbent. Fold the non-absorbent around the elastic member, preferably less than twice, to form an elongated soft wind having an extreme end and a second end. Then bend the wind soft on itself in such a way that the edges first and second are aligned adjacent to each other and the soft wind contains at least two folds of them. The elastic member extends between at least two of the folds. The soft wind is compressed contonees in an elongated applicator having an insertion end and a tail end with the elastic member located at at least the insertion edge. The resilient member is capable of expanding at least one part of the applicator to provide support to the urethra of a woman when the applicator is properly inserted into the vagina of a woman.

The general object of this invention is to provide a device for urinary incontinence and a method for making the device. A more specific object of this invention is to provide a device for non-absorbent urinary incontinence which is designed to be placed in the vagina of a woman to provide support to the urethra of the woman to prevent the loss of involuntary orin commonly associated with urinari incontinence due to tension.

Another object of this invention is to provide a device for urinary incontinence which is easy to insert and remove and which is convenient to use. A further object of this invention is to provide a method for making a device for urinary incontinence which is efficient and economical.

Yet another object of this invention is to provide a device for urinary incontinence which can be purchased by a consumer without a prescription Still further, an object of this invention is to provide a device for urinary incontinence which can be used together with a sanitary napkin during a woman's menstrual period.

Other objects and advantages of the present invention will be more apparent to those with an art skill in view of the following description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of a position of elastic member on a non-absorbent and a cover.

Figure 2 is a perspective view of the combination shown in Figure 1 after being bent along its longitudinal central axis.

Figure 3 is a perspective view of a folded member shown in Figure 2 after having been folded. A second time along its longitudinal center axis.

Figure 4 is a perspective view of the soft wind bent twice showing the cover overlapping on itself.

Figure 5 is a side view of the soft wind bent in a generally M-shaped profile with the first and second ends being aligned side by side.

Figure 6 is a side view of the smooth wind shown in Figure 5 after it has been compressed in an applicator and has a withdrawal rope attached to the first and second ends.

Figure 7 is a mid-sagittal section of a human torso showing the urinary incontinence device placed in the vagina and expanded to provide support for the musculature and tissue near the urethrovaginal myofascia region and the urethra.

Figure 8 is an alternate embodiment showing an elastic member placed in the form of a sandwich between two adjacent layers.

Figure 9 is a perspective view of an alternate embodiment of a urinary incontinence device having a short elastic member placed on an absorbent n so that the elastic member is aligned along the central longitudinal axis of the non-absorbent and is off center to one side of the central transverse axis of the absorbent n.

Fig. 10 is a perspective view of the combination shown in Fig. 9 after it has been bent along the central longitudinal axis.

Figure 11 is a side view of the smooth wind shown in Figure 10 after it has been bent into a generally M-shaped profile with the first second ends being aligned to one side of each other and retained by a withdrawal rope. .

Figure 12 is a flow chart of a method for forming a device for urinary incontinence.

Figure 13 is a flow view of an alternate method for forming a device for urinary incontinence.

DETAILED DESCRIPTION OF THE PREFERRED INCORPORATIONS In Figure 6 the device for urinary incontinence 10 is shown, which is designed to be inserted into a woman's vagina and expand as a pair to relieve or eliminate the involuntary passage of urine through the urethra from the bladder. The expansion of the device for non-absorbent urinary incontinence 10 provides a stable backdrop for the musculature and the tissue of the body located in the urethrovaginal myofascial compressed on itself. In addition, the expansion of the device for urinary incontinence 10 in the vagina helps the urinary sphincter muscle to maintain a configuration in transverse section circuLar. When the configuration in circular transverse section is maintained, the sphincter muscle can close properly and decrease the tendency to involuntary leakage of urine due to stress urinary incontinence.

Referring to Figures 1-6, the urinary incontinence device 10 includes an elastic member 1 and a non-absorbent member 14. The elastic member 12 can be n absorbent or at least partially absorbent from body fluids. However, there is no functional advantage to make the elastic member 12 absorbent because the urinary incontinence device 10 does not function in a similar manner as a catamenial plug does. In fact, the urinary incontinence device 10 function completely differently than an absorbent catamenia cap.

The elastic member 12 may be of a natural or synthetic material, which has the ability to recover rapidly back to approximately its original dimension and / or shape. Such a change for the elastic member 12 can be created by changes in intra-abdominal pressure. An elastic material is a material which can return or resume the original shape or position after being bent, stretched compressed. The elastic member 12 must exhibit elasticity flexibility so that it can be stretched or compressed and still retain the ability to return to approximately its original shape.

Two natural materials from which the elastic member 12 can be formed include natural rubber and wool. The number of synthetic materials from which the elastic member 12 can be formed is much greater. Synthetic materials which may be used include polyolefins, polyurethanes, polyethylene oxide (PEO), and polyvinyl alcohol (PVA), as well as mixtures thereof. The elastic member 12 can also be formed of elastic fibers constructed of polyolefin-based fibers, polyethylene oxide fibers, and similar hydrophobic rayon fibers, which preferably will have characteristics similar to those of an elastic foam. The elastic fibers may be formed of chemically bonded cellulose fibers cross-linked or twisted or a mixture thereof. In addition, the elastic member 12 can be formed of either an open cell foam or a closed cell foam.

The elastic member 12 can also be made moistenable foam. An open-cell foam that works well and has good elastic properties is commercially available under the ACQUELL® brand. The "ACQUELL" product is sold by Sentinel Products Corporation, which has an office located at 70 Airport Broad, Hyannis, Massachusetts 02601. A closed-cell polyethylene foam that has good flexibility characteristics also worked well. This foam is sold commercially under the brand VOLARA®. The product "VOLARA" is available from Voltex, a division of Sekisui America Corporation that has an office located at 100 Shepard Street, Lawrence, Massachusetts 01843.

The elastic member 12 must be capable of having what is known as "dry and wet" expansion characteristics. In other words, the elastic member 12 must be made of a material which is capable of expanding or contracting back to its original configuration in a dry state, in a wet state or in a semi-dry and moist state. The dry expansion of the urinary incontinence device 10 is beneficial in the sense that the device does not have to be wetted by the body fluid before the elastic member 12 is able to expand within the vagina.

In Figure 1, the elastic member 12 is shown as a narrow strip of material which is rectangular in cross section. However, the elastic member 12 can have a square, circular, oval configuration or any other configuration in desired cross section. Preferably, the elastic member 12 will have a uniform thickness and width. If desired, the dimensions of elastic member 12 do not have to be uniform. The narrow pull of the elastic member 12 has a length Lx which is equal to the length L2 of the non-absorbent 14. However, the length Lx of the elastic member 12 may be less than the length L2 of the non-absorbent member 14. The elastic member 12 It also has a width Wx which can vary from about .2 inches (about 6.4 millimeters) to about 1. inches (about 38.1 millimeters), preferably about .5 inches (about 12.7 millimeters) around 1 inch (about 25.4 mm) and more preferably about 1 inch (about 25.4 mm). The elastic member 12 also has a thickness T which can vary from about .1 inches (about 2.5 millimeters) to about 1 inch (about 25.4 millimeters), preferably less than about .5 inches (about 12.7 millimeters). millimeters), and more preferably, less d about .4 inches (about 10 millimeters).

When the elastic member 12 has a round or circular cross-sectional configuration, the diameter may vary from about .25 inches (about 6.4 millimeters) to about 1.5 inches (about 38. millimeters), preferably between about .25 inch (about 6.4 millimeters) to about 1 inch (about 25.4 millimeters), and more preferably, less than about .5 inches (about 12.7 millimeters). For regular cross-sectional shapes such as an oval, two-lobed, three-lobed, one-ellipse, etc., the largest dimension n must be greater than about inches (about 5 millimeters).

Referring to Figure 1, the elastic member 12 is placed on an absorbent 14 so that it yaks parallel and adjacent to the central longitudinal axis XX of the absorbent n 14. It does not matter which side of the central longitudinal axis XX the elastic member 12 is aligned For best results, the non-absorbent 14 must have a length L2 which is equal to or greater in dimension than the length Lx of the elastic member 12. In addition, the non-absorbent 14 must have a width W2 which is about two at about eight times the width x of the elastic member 12, preferably, the width W is about four times the width Wx of the elastic member 12. The thickness T2 of the non-absorbent 14 can be less than, equal to or greater than thickness Tx of the elastic member 12. The absorbent n 14 may be a material of a stratum or may be constructed of two or more layers or layers.

The non-absorbent 14 is constructed of materiale that exhibit few, and preferably no absorbent properties. The non-absorbent differs from the catamenial plug in that it does not function to absorb body fluid. Instead, the nonabsorbent 16 is designed to bridge the vagina and support the musculature and tissue of the body located in the urethrovaginal myofascial area. By doing this, the urethra can be compressed sufficiently to stop the flow of urine and the support can be provided to the urinary sphincter muscle so that it can function properly.

For the purposes of this invention, an absorbent n is defined as a material in which fibers n absorb significant amounts of moisture within the fibr itself. It should be recognized that virtually all materials will absorb some small amount of moisture. A fiber is considered not to be absorbent for present purposes if it does not intrinsically gain more than about 6 percent by weight when a fully dried fiber is held at 21 ° C and 65 percent relative humidity for 24 hours. Non-absorbent materials include but are not limited to nylons, scratches, LYCRA® spun cellulose, KEVLAR®, similar carbon fibers. The "LYCRA" and the "KEVLAR" are trademarks of E.I. DuPont d Nemours & Company which has an office at 1007 Marke Street, Wilmington, Delaware 19801. One such non-absorbent 14 is a fabric made of bicomponent fibers which is commercially available from Chisso Corporation having an office at 1411 Broadway, 35th Floor, New York, New York. Tale fibers are sold under the name "Chicom ESC Bicomponent Fiber" and consist of a polypropylene core surrounded by a polyethylene sheath. The fibers that work well have a denier of 3 and are 38 millimeters in length. Other bicomponent fibers made of polypropylene, polyethylene, etc., are commercially available from suppliers such as Exxon and Do Chemical, as well as from other vendors.

Alternatively, the non-absorbent 14 may be an absorbent material such as a cotton / rayon mixture which has been chemically treated with a surfactant to render it n absorbent. However, n-absorbent fiber composite materials really work well.

Referring again to Figure 1, the absorbent n 14 is shown as being placed on a liquid-permeable or liquid-impermeable cover 16. The cover 16 is an optional element and does not require to be present to form the device for urinary incontinence. However, the cover 16 can provide a smooth outer surface which may or may not be chemically treated to facilitate insertion and / or removal inside and outside of a woman's vagina. When the cover 16 is present, it must have a length L3 which is equal to the length L2 of non-absorbent 14 or greater than this. The cover 16 must have a width W3 which is greater than the width W of the non-absorbent 14 The purpose of the larger dimension for the width W3 is that it allows the cover 16 to be folded on itself and be joined to itself by pressure, heat, a combination of heat and pressure, or by means of some other conventional means known to those with skill in the art. If the cover 16 is formed of a material which does not easily unite itself, an adhesive, rubber, other means of attachment or fastening may be used. If desired, the cover 1 can be simply folded on itself.

The cover 16 can be either liquid permeable or liquid impervious. When the cover 16 is impermeable to the liquid, it serves to block the body fluids from contact with the non-absorbent 14. Since the absorbent n 14 is not designed to absorb any body fluid, it can be permeable to liquid. Liquid permeable materials include woven materials and fabrics having a porous substrate. Woven materials include textile fabrics, which can be made of cotton rayon or polyolefins. The polyolefins can be either continuous or basic filaments. Non-woven materials may include spunbond, bonded and carded fabrics and hydroentangled fabrics. The bonded and carded spunbonded fabrics are sold commercially by Kimberly-Clar Corporation, which has an office at 401 North Lake Street, Neenah, Wisconsin 54956. Other material is not available which can be used as the cover 16 is formed from 100 percent d polyester fibers held together with a binder. This material is known as a carded and bonded knit with powder (PBCW). The carded and bonded fabric is commercially available from HDK Industries, Inc., which has an office at 30 Arcadia Drive, in Greenville, South Carolina 29609.

The cover 16 can also be constructed of liquid impervious material. A good liquid impervious material is a micro-etched polymeric film, such as polyethylene or a polypropylene. Two-component films can also be used. A preferred liquid impervious material is a polyethylene film. The thickness of the cover 16 can vary from from about .1 millimeter to about 5 millimeters, preferably less than about .5 millimeters, and more preferably, less than about .2 millimeters.

Referring to Figs. 1-4, the combination of the elastic member 12, the non-absorbent 14 and the cover 1 shown in Fig. 1, are folded along the longitudinal central ej XX to obtain a bent member 18 which has a central longitudinal axis X ^ XL. The bent member 18, see Figure 2, is then bent a second time along its central longitudinal axis X-Xx to obtain an elongated soft wind 20 having a central longitudinal axis X2-X2, see figure 3. The free end of the cover 16 can then be folded on itself and attached or held, or left on hold if desired, to form a smooth elongated cylindrically shaped wind, see Figure 4. The smooth wind 22 has a first end 24 and a second end 26.

It should be noted that the above discussion is directed to bending the layers of the material 12, 14 and 16 on themselves to form the gentle wind 22. However, the soft wind 22 can be formed by winding, wrapping, bending and / or manipulation of one or more of the layers in a known form to obtain a cylindrical or elongated member.

Referring to Figure 5, the gentle wind 22 is bent or folded on itself so that the first and second ends, 24 and 26 respectively, are aligned side by side and the gentle wind 22 contains at least two bends. and 30 located between them. By being aligned "one adjacent to the other" it is meant that the first and second end, 24 and 26 respectively, are placed side-by-side, parallel to each other or axially offset or radially spaced apart from each other, or are placed on each other. Some other type of arrangement whereby the first and second ends 24 and 26 respectively, are close to one another. Preferably, the joined or opened edges of the cover 1 should be placed inside when the first second, 24 and 26 ends respectively are aligned one to another lad.

Preferably, the gentle wind 22 will contain tremours 28, 30 and 32 which are located between the first and second ends, 24 and 26 respectively, to give the smooth wind 22 a generally M-shaped profile. In the M-shaped profile generally, the gentle wind 22 is bent at the point 28 to form a first part 34 and is bent a second time at the point 30 to form a second part 36 and a third part 38. The first parts and third, 34 and 3 respectively, preferably have approximately the same length, even though their lengths may differ if desired. It is also possible to form the first, second and third parts 34, 36 and 38 so that they have approximately the same length. For example, if the gentle wind 22 has a length of about 6 inches (about 152 millimeters) each of the parts 34, 36 and 38 can have a length of about 2 inches (about 51 millimeters).

The elastic member 12 should extend between at least two of the bends 28, 30 and 32. In Figure 5, the elastic member 12 extends the full length of the soft bell 22 from the first end 24 to the second end 26. If However, it is not necessary for the elastic member 12 s to extend a distance greater than the distance between the two adjacent folds. For example, the elastic member 12 can be extended by the distance between the bends 28 and 30, between 2 and 32 or between 30 and 32.

Depending on the material from which the elastic member 12 is constructed, it is advantageous to use an elastic member 12 which has a length which bridges through the folds 28 and 30 and extends slightly beyond these. This arrangement will ensure that the Soft wind 22 will open completely once it is placed inside a woman's vagina.

Still referring to Figure 5, the third double 32 provides the smooth wind 22 with the shape profile of generally. The third fold 32 can be placed at an equal or unequal distance between the first and second bends 38 and 30 respectively. When the third bend 32 is placed at an equal distance between the first and second bends, 28-30 respectively, the third bending 32 will be axially aligned along a central length axis ZZ. The central longitudinal ej ZZ, see FIG. 5, vertically divides the generally M-shaped profile of the soft wind 22 into the identical left and right images. It is also possible to form the third bend 32 closest to any first or second folds, 28 and 3 respectively, if desired. The third fold 32 causes the middle part of the elastic member 12 to be split into two parts so that a V shape is obtained.

Referring to Figure 6, the gentle wind 22 is compressed in an applicator 40 having an insertion end 42 and a tail end 44. The applicator 40 may have any desired shape but preferably, it will have a generally cylindrical shape with a configuration in circular cross section. An alternate profile will be of a rectangular cross section configuration. Applied 40 is an elongate member having a length L4 and a width W4. When the applicator 40 is round in cross section, s diameter will be equal to the width dimension W4. The length L can vary from about .4 inches (about 1 millimeters) to about 4.7 inches (about 12 millimeters), preferably the length L4 will vary from between about 1.5 inches (about 38 millimeters) around 2.5 inches (about 64 millimeters.) More preferably, the length L4 will be about 2 inches (around 51 millimeters). The width W4 may vary from between about .2 inches (about 5 millimeters) about 2.5 inches (about 64 millimeters), preferably the width W4 will vary from about between about .5 inches (about 12.7 millimeters) to about 2. inches (about 60 millimeters). More preferably, the width W4 will be less than about 1.6 inches (about 40 millimeters). The applicator 40 also has a length R which is a diagonal line drawn between the fold vertex 28 and the inside surface of the fold 32. This dimension R4 is also equal in distance to a diagonal line drawn between the apex of the bend 30 and the interior fold surface 32. The R4 dimension can vary from about .2 inches (about 5 millimeters) to about 1. inches (about 30 millimeters). Preferably, the R4 dimension will be about 1 inch (about 25. millimeters) in length. Another way of saying the length of the dimension R4 is to say that it must have a length l which is equal to at least about 25 percent of the length L4 of the applicator 40. This length will be sufficient to ensure that the applicator 40 can expand laterally outward and provide pressure against the interior walls of the woman's vagina.

Still referring to Figure 6, the insertion end 42 of the applicator 40 is designed to be the first part of the applied 440 which enters the vaginal cavity of the woman. It should be noted that, while in use, the applicator 4 will be placed completely within the vagina of the woman. The insertion end 42 contains a crack 46 formed by the bend 32. Because the soft wind 22 has a generally M-shaped profile., the insertion end 42 may contain an equal amount and, preferably, a larger amount of non-absorbent material than the tail end 44. When a larger amount of non-absorbent 14 may be present at the insertion end 42, the diameter The insertion end exterior 42 must be equal to the tail end outer diameter 44. The amount of the non-absorbent material at the insertion end 42 will have to be densified to a greater extent than the non-absorbent material constituting the tail end. By having a larger amount of non-absorbent 14 at the insertion end 42, the urinary incontinence device 10 will be able to expand and better support the musculature and body tissue located on one side of the urethra and cause it to compress. This will eliminate the involuntary escaping of urine through the urethra.

When the applicator 40 is formed, the elastic member 12, the non-absorbent member 14 and the cover 16, if present, are all compressed. The applicator 40 can be compressed radially and longitudinally or it can be compressed only in the radial direction. The elastic member 1 must be located at least at the insertion end 4 of the applicator 40. The compression step must not detrimentally affect the function of the elastic member 12. In other words, the elastic member 12 has to be capable of expanding. outward or to its original configuration once the urinary incontinence device 10 is inserted into a woman's vagina. The elastic member 12 should be at least one portion of the applicator 40 to provide support to a woman's urethra when properly inserted into a woman's vagina.

Still referring to Figure 6, the compressed applied 40 is punched at its tail end 44 to form an opening or hole 48 which extends completely through the first and third sections 34 and 3 respectively. The opening 46 may be formed perpendicular to the central longitudinal axis Y- Y or at an angle thereto. Preferably, the opening 48 is spaced by a short distance from the first and second ends, 24 and 26 respectively. The opening 48 may be located at a distance of desd between about .1 inch (about 2.5 millimeters) about .5 inches (about 12.7 millimeters) from the first and second ends, 24 and 26, respectively. Most preferably, the opening 48 is located at about .25 inches (about 6.4 millimeters) from each of the first and second ends, 24 and 26, respectively. The opening 48 is designed to allow a withdrawal rope 5 to be placed through the applicator 40 and to be secured thereto. The withdrawal cord 50 will help to remove the urinary incontinence device 10 from a woman's vagina. The withdrawal cord 50 is attached to the non-absorbent 14 and preferably the first and second ends, 24 and 26 respectively, of soft wind 22. The opening 48 may be formed with a needle, a punch or some other type of perforating device known from the art. those with a skill in art. The withdrawal rope 50 is passed through the opening 48 and is tied on itself to secure it to the non-absorbent 14. The free ends of the withdrawal rope 50 are then tied in a nud 52 to ensure that the rope The withdrawal 50 will not be separated from the applicator 40. The knot 52 also serves to prevent it from burning the withdrawal rope 50 and to provide a point where a woman can grab the withdrawal rope 5 when she is ready to remove the device. urinary incontinence 10 of the vagina.

It should be noted that the withdrawal cord 50 retains the first and second ends, 24 and 26 respectively, in direct contact with each other and will limit the amount by which they can expand while being placed inside the vagina of a woman. It should be noted that the withdrawal rope 50 can be secured and / or secured to various areas of the applicator 40 and can pass through one or more of the elastic member 12, of the absorbent n 14, of the cover 16, if present, or through the three members, if desired. The opening 58 may alternatively form in the gentle wind 22 before it is compressed and the withdrawal rope 50 may be attached either before the soft wind 22 is compressed or after the smooth wind 22 is compressed inside the applicator 40.

The withdrawal rope 50 can be constructed of various types of threads or tapes. A thread or ribbon made of 10 percent cotton fibers works well. The withdrawal cord 50 should have a length which extends beyond the end of the urinary incontinence device 10 from about 2 inches (about 51 millimeters) to about 8 inches (about 203 millimeters) preferably, from between about 4 inch (about 10 millimeters) to about 6 inches (about 152 millimeters), and more preferably, from about inches (about 127 millimeters). The withdrawal rope 5 can be dyed and / or treated with an agent against the transmission, such as wax, before being secured to applicator 40. The agent against the transmission will reduce in expected manner will prevent the body fluids are transmitted along the withdrawal cord 50 and contact the inner surface of a woman's undergarment A clean and dry removal rope 50 is preferred by the wearer, especially when she is going to remove the device d urinary incontinence 10 of your vagina.

Referring to Figure 7, the compressed applied 40 is shown having been inserted into the vagina of a female 54 and it is shown in an expanded state 56. The expanded applicator 56 has a length L5 and a wide diameter W5. The expanded applicator 56 also has a generally triangular shape which is closed at the bottom end or tail end 44 by means of the clamping of the withdrawal cord 50. Even when inside the vaginal cavity 54, the elastic member 12 will expand. thus causing the first and third parts 34 and 38, respectively, to jump outward and extend through the vaginal opening. The device for urinary incontinence 10 should be placed below the cervix. The elastic and flexible characteristics of the elastic member 12 allow the applicator 4 to quickly recover its compressed and deformed shape. This allows the urinary incontinence device 10 to make contact and conform intimately more ideally to the space within the walls of the vagina and to press against the side walls and convolutions of a woman's vagina 54.

A female urethra 58 is located on one side and anterior to the vagina 54. The anus of the female 60 is located on the posterior side of the vagina 54. The urethra 58 is a conduit which provides a means to remove the urinary origin. woman's body The urethra 58 is a conduit for removing urine which has accumulated in the bladder 62 of a woman an external orifice located at the lower end of the urethra 58. A urinary sphincter muscle 64 is located in the upper part of the urethra 58 on one side of the inferior surface of the bladder 62. The sphincter muscle 64 operates to prevent the loss of involuntary urine. However, with age, the pelvic floor muscles begin to be bagged and the cross-sectional configuration of the sphincter muscle can change from a circular profile to a non-circular profile. Tale changes increase the chance that a woman will experience an involuntary loss of urine. Between the vagina 54 and the urethra 5 is the urethrovaginal myofascial area 66. This area 66 is made up of the musculature and the body tissue and the body tissue is extremely docile. The vagina 54 contains a plurality of roughnesses (not shown) which cover its inner walls 68. The roughnesses consist of crease wrinkles in the body tissue which allow the expansion and contraction of the lateral walls 68 of the vagina 54.

By comparing the compressed applicator 40, shown in FIG. 6, with the expanded applicator 56, shown in FIG. 7, one will quickly recognize that the width W5 of the expanded applied 56 is much greater than the width W4 of the compressed applied 40. However, the length Ls of the expanded applique 56 is approximately equal to the length L4 of the compressed applicator 40. Preferably, the length L5 of the expanded applicator 56 will be slightly larger than the length L of the compressed applicator 40. The thickness (T) of the gentle wind 2 or The dimension in the z direction (see Figure 4) should vary from between about .5 inches (about 1 millimeters) to about 1.5 inches (about 3 millimeters). This distance will not change essentially once the urinary incontinence device 10 is inserted into the vagina 54. As the applicator 4 expands by the action of the elastic member 12 to the expanded state 56, and expanded applicator 56 will apply pressure against the body tissue in the urethrovaginal myofascial area 66. This action will provide a stable backdrop to allow the urethra of the woman to compress when the intra-abdominal pressure increases. In other words, a part of the urethra 58 which is about 1.5 inches (about 38 millimeters) long and through which the urine flows, will be compressed and pinched on itself thus preventing urine from passing through. Of the same. In addition, support will be provided to the region near the sphincter muscle 64 so that it has a superior tendency to maintain a configuration in circular cross section and operate properly. One or both of these actions will reduce and / or prevent the loss of involuntary urination due to stress urinary incontinence.

Referring to Figure 8, there is shown an alternate incorporation of a compound 70 wherein an elastic member 72 is sandwiched between two non-absorbent material layers 74 and 76. The elastic member 72 can be constructed to be similar in size and configuration to at least one of the nonabsorbent layers 74 or 76, preferably is constructed to be similar in size configuration to the two nonabsorbent layers 74 and 76. When the composite 70 is a laminate, it will be easy to handle and form in a gentle wind. The composite 70 can be constructed to be a narrow strip, for example, having an elongated rectangular configuration or it can be formed as a fabric or long sheet which can then be cut into more manageable sizes. The composite 70 can be replaced by the three layer combination shown in Figure 1. Therefore, the composite 70 can be folded on itself one or more times it can then be folded along its length to form a generally gentle wind. in the form of M similar to that shown in figure 5.

Referring now to Figures 9-11, there is shown another embodiment of a device for urinary incontinence 78 which is constructed of an elastic member 80 and a non-absorbent member 82. The elastic member 8 has a length L6 which is less than 50 percent, preferably from between about 20 percent about 40 percent of the length L7 of the non-absorbent 82. The elastic member 80 is positioned relative to a surface of the non-absorbent 82 so that it lies at a of both the central longitudinal axis XX and the central transverse axis YY. The elastic member 80 and the non-absorbent member 82 can then be bent in half to obtain a bent member 8 as shown in Figure 10. The bent member 84 can be bent transversally an O 'more times as explained above in relation to the Figures 1-4, if desired. The folded member is then bent in two or more places along the length to obtain a generally M-shaped profile as shown in Figure 11.

In Figure 11, the device for urinary incontinence 78 clearly shows the elastic member 80 which is located on only one side of the central vertical axis Z-Z The elastic member 80 can be offset from the central vertical ej Z-Z by any desired distance or it can have an edge which is coterminal to the vertical axis centered Z-Z. One will note that the elastic member 80 is located between the folds 28 and 32. However, the elastic member 80 can be placed between the folds 30 and 32. Alternatively, the elastic member 80 can extend between the folds 28 and 30, if you want For this to occur, the elastic member 80 should extend across the central vertical axis rather than being positioned on only one side thereof as shown in Figure 9.

The elastic and flexible properties of the elastic member 80 should be adequate to ensure that the insertion end 42 will open and expand outwardly by a sufficient amount so that the urinary incontinence device 78 can function properly.

Although not shown in any of the drawings, it is contemplated that the compressed edge 40 may be housed in a paper, cardboard or plastic applique to facilitate insertion of the urinary incontinence device 10 or 78 into the vagina of the patient. a female 54. The appliqué may be identical to a plug applicator, if desired, and may be constructed of one or more hollow tubes which will retain the urinary incontinence device 10 or 78 at an established diameter and / or in a configuration in cross section until the user is ready to use the product. In addition, insertion of the applicator urinary incontinence device 10 into the human body can be achieved by using a plunger, such as a two-piece applicator, or digital insertion by which the user can use one of her fingers. An example of a plug applicator is shown in United States Patent No. 5,795,346 which was issued to Achter et al. On August 18, 1998 and is entitled "PLUG THAT HAS AN ELASTIC MEMBER". This patent is incorporated here by reference and is part of it.

METHOD The method for forming the device for urinary incontinence 10 or 78 will be explained with reference to the flow diagrams shown in Figures 12 and 13. The method includes the steps of forming or cutting a non-absorbent 14 e into a desired geometric shape. A preferred form for the absorbent n 14 is a rectangle even though many shapes will serve. The non-absorbent 14 will have a desired length, width and thickness. The elastic member 12 is placed on or to one side d of a surface of the non-absorbent 14 to form a set of two elements. For best results, the elastic member 12 can be aligned to one side of the central longitudinal axis X-of the non-absorbent 14. By "adjacent to" is meant that the elastic member 12 can have an edge which is cotermined with the axis longitudinal central XX or elastic member 12 may be offset or spaced from central longitudinal axis XX.

The non-absorbent 14 can be placed on top of the cover material 16 so that the cover 16 is located on one side of a surface of the non-absorbent 14 and the elastic member 12 is located on one side of the opposite surface of the non-absorbent 14. cover 16 is an optional feature and does not require to be present to make a device for urinary incontinence 10 or 78. The absorbent n 14, together with the cover 16 are then folded around the elastic member 12. A method for bending is to bend the non-absorbent 14 and cover 16, if present transversely on themselves so that bent member 18 is formed and elastic member 12 will be located on one side of longitudinal fold line XLXL. The bent member 18 can then be bent a second time in a similar manner to give a gentle wind 20 as shown in Figure 3. When a cover 16 is present, the cover 16 can be wrapped or folded on itself and can be attached or clamped to another part of the cover 16 to form a smooth elongated cylindrical wind 20, see Figure 4.

It should be noted that the different materials forming the elastic member 12, the non-absorbent member 14 and the cover 16 can be folded one or more times to obtain a predetermined diameter or cross-sectional configuration. In addition, the materials may be rolled, wrapped, folded or otherwise manipulated to be fixed in a gentle wind 22. It has been found that bending is a preferred way of achieving the formation of a gentle wind wherein the elastic member 12 is aligned correctly there.

Once a gentle wind is formed, it is bent or folded at two or more places along the length of the smooth wind 22 to arrive at a generally triangular profile when viewed perpendicular to the folds.

Preferably, the gentle wind 22 is bent so that it is. . . . * - - -contains three bends and acquires a generally M-shaped profile. An example of the usual form of M is shown in Figure 5. The location or position of bends 28, 3 and 32 may vary but an embodiment preferred is shown in Figure 5.

After the gentle wind 22 has been bent into a generally triangular or M-shaped profile, it is compressed radially in an applicator 40, as shown in Figure 6. The gentle wind 22 can be compressed only in the radial direction. or it can be compressed both axially and radially. Since the applicator 40 contains more material at the insertion end 42 than at the tail end 44, the insertion end 42 will be more dense since the applicator 4 has the same diameter or area in cross section through its full length. . This added material at the insertion end 42 will ensure that the applicator 40 opens and expands, once it is inserted into a woman's vagina, that it will provide a stable backdrop for the urethra and what it will be able to provide. the pressure required against tissue from the surrounding body located in the urethrovaginal myofascial area as to restrict the involuntary flow of urine through the urethra.

The compressed applicator 40 can then have a hole or bore 48 formed through its collet end 44 to receive a withdrawal rope 50. The opening 48 can be formed with a needle, a punch or some other mechanical, electrical, chemical means, hydraulic or pneumatic The perforation 48 must be aligned parallel to the first and second ends, 24 and 26, respectively of the gentle wind 2 and must be sufficiently spaced apart from the ends 24 and 26 to ensure that when a woman pulls the draw rope 50 the it will not break through the material and separate from the applicator 40. The withdrawal rope 50 can be inserted through the perforation 48 and tied on itself by cinching it tightly against the applicator 40. The pair d free ends of the rope 50 can then be tied in a knot 52 to increase the safety that the withdrawal rope 50 will not separate from the applicator 40.

It should be noted that the discussion mentioned above describes the perforation of the applicator 40 to form the aperture 48. Another option will be to perforate the gentle wind 22. It should also be noted that FIG. 6 shows the aperture 48 passing through the elastic member 12 of the non-absorbent 14 and liner 16 while in figure 11, opening 48 passes only through nonabsorbent 14. It is also possible to form the opening 48 through only the nonabsorbent 14 of the cover 16.

Even though the invention has been described in conjunction with several specific embodiments it will be understood that many alternatives, modifications and variations will be apparent to those skilled in the art in light of the foregoing description. Therefore, this invention is intended to encompass all those alternatives, modifications and variations which fall within the spirit and scope of the appended claims.

Claims (21)

R E I V I N D I C A C I O N S
1. A device for urinary incontinence that includes: a) an elastic member; b) a non-absorbent at least partially surrounds said elastic member, said non-absorbent and elastic member are formed in an elongated soft wind having a first end and a second end, said smooth wind is bent over itself so that said The first and second ends are aligned side by side and said soft wind contains at least two folds between them, said elastic member extends between at least two of said folds, said soft wind is compressed into an applied elongate that has an insertion end and a collet end with said resilient member located at least at an insertion end and said resilient member is capable of expanding at least a portion of said applicator to provide a support backdrop for the urethra of the applicator. A woman when inserted inside a woman's vagina.
2. 2. The device for urinary incontinence as claimed in clause 1, characterized in that said elastic member is placed in the form of a sandwich between two non-absorbent layers.
3. 3. The device for urinary incontinence as claimed in clause 2, characterized in that said elastic member is similar in size and configuration to at least one of said non-absorbent layers.
4. 4. The device for urinary incontinence as claimed in clause 3, characterized in that said elastic member is similar in size and configuration to said two layers of non-absorbent.
5. A device for urinary incontinence that includes: a) an elastic member; b) a non-absorbent at least partially surrounding said resilient member, said non-absorbent and elastic member are formed in an elongated soft wind having a first end and a second end, said smooth wind being bent over itself so that the First second ends are aligned to one side of each other and said soft wind contains at least two folds between them, said elastic member extends between at least two of said folds, said soft wind is compressed in an applied elongate that has an insertion end and a collet end with said resilient member located at least at an insertion end and said resilient member is capable of expanding at least a portion of said applicator to provide a support backdrop for the urethra of the applicator. a woman when inserted into a woman's vagina; Y c) withdrawal means to remove incontinence device from a woman's vagina.
6. 6. The device for urinary incontinence as claimed in clause 1, characterized in that said elastic member is made of polyurethane.
7. 7. The device for urinary incontinence as claimed in clause 1, characterized in that said elastic member is made of natural rubber.
8. 8. The device for urinary incontinence as claimed in clause 1, characterized in that said elastic member is an open cell foam.
9. 9. The device for urinary incontinence as claimed in clause 1, characterized in that said elastic member is a closed cell foam.
10. 10. The device for urinary incontinence as claimed in clause 1, characterized in that said resilient member is formed of fibers of twisted, crimped or chemically cross-linked cells or d of a mixture thereof.
11. 11. A device for urinary incontinence that includes: a) an elastic member; b) a non-absorbent at least partially surrounding said elastic member, said non-absorbent and elastic member are formed in an elongated soft wind having a first end and a second end, said smooth wind is bent over itself so that said first and second ends are aligned side by side and said soft wind contains at least two folds there between themsaid resilient member extends between at least two of said bends, said soft wind is compressed into an elongate applied having an insertion end and a collet end with said elastic member located at least at an insertion end thereof and said elastic member is able to expand at least a part of said applicator to provide a supportive backdrop for a female urethra when inserted into a woman's vagina; c) a cover surrounding said gentle wind; d) withdrawal means to remove the incontinence device from a woman's vagina.
12. 12. The device for urinary incontinence as claimed in clause 11, characterized in that said device has a central vertical axis and said elastic member is located only on one side of said central vertical axis.
13. 13. The device for urinary incontinence as claimed in clause 12, characterized in that the elastic member is made of wool.
14. 14. The device for urinary incontinence as claimed in clause 11, characterized in that the cover is not absorbent.
15. 15. The device for urinary incontinence as claimed in clause 11, characterized in that said gentle wind is compressed only in a radial direction.
16. 16. A method for making a device for urinary incontinence, said method comprises the steps of: a) cutting a non-absorbent in a configuration having a central longitudinal axis; b) aligning an elastic member adjacent to said central longitudinal axis of said non-absorbent; c) bending said absorbent and said elastic member to form an elongated soft wind having a prime end and a second end; d) bending said smooth wind on itself so that said first and second ends are aligned side by side and said soft wind contains at least two bends therebetween therebetween, said elastic member extending between at least two of said folds; Y e) compressing said soft wind into an elongate applied having an insertion end and a collet end with said elastic member located at least at an insert end, whereby the elastic member is capable of expanding at least a part of said applicator to provide a support backdrop for the urethra of a woman when said applicator is inserted in the vagina of a woman.
17. 17. The device for urinary incontinence as claimed in clause 16, characterized in that said gentle wind is compressed radially.
18. 18. The device for urinary incontinence as claimed in clause 16, characterized in that said tail end of said applicator is perforated to provide an opening for holding withdrawal means.
19. 19. The device for urinary incontinence as claimed in clause 18, characterized in that said withdrawal cord is inserted through said opening is tied on itself and said withdrawal cord has a pair of free ends which are tied together to prevent the withdrawal cord from separating from the applicator.
20. 20. The device for urinary incontinence as claimed in clause 16, characterized in that said non-absorbent is aligned on a cover before the elastic member is aligned on the non-absorbent and all three members are bent to form a smooth wind. lengthened
21. 21. A method for making a device for urinary incontinence, said method comprises the steps of: a) cutting a non-absorbent in a rectangular configuration having a central longitudinal axis; b) aligning a rectangular strip of elastic member parallel and adjacent to said central longitudinal axis d said non-absorbent; c) bending said non-absorbent around elastic member to form a combination and folding said combination again to form an elongated soft wind having a first end and a second end; d) bending said smooth wind on itself so that the first and second ends are aligned side by side and said soft wind contains at least two bends therebetween, said elastic member extending between at least two of said bends; e) radially compressing said soft wind into an elongated applicator having an insertion end and a tail end with said elastic member located at least at said insertion end, whereby said resilient member is capable of expanding at least one part of said applicator to provide a support backdrop for a woman's urethra when said applicator is inserted into a woman's vagina; and f) securing a withdrawal cord to an applicator to form a device for urinary incontinence. SUMMARY A device for urinary incontinence is described along with a method for making the device. The device includes an elastic member and a non-absorbent member which at least partially surrounds the elastic member. The absorbent n and the elastic member are formed in an elongated soft wind having a first end and a second end. The gentle wind is bent over itself so that the first and second ends are aligned side by side and the soft wind contains at least two bends between them. The elastic member extends between at least two of the folds. The gentle wind is then compressed into an elongate applied having an insertion end and a collet end with the elastic member located at least at the insertion end. The elastic member is capable of expanding at least a part of the applicator to provide a support backdrop for a woman's urethra when it is inserted into a woman's vagina. The method includes the steps of surrounding the elastic member with the non-absorbent, folding the two materials to form a soft wind, bending the soft wind in a generally M-shaped configuration and then compressing the soft wind into an elongated applicator.