(19)
(11)EP 2 654 645 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
09.09.2020 Bulletin 2020/37

(21)Application number: 11850906.6

(22)Date of filing:  16.11.2011
(51)International Patent Classification (IPC): 
A61F 13/30(2006.01)
A61F 13/26(2006.01)
A61F 13/20(2006.01)
A61F 13/34(2006.01)
(86)International application number:
PCT/IB2011/055124
(87)International publication number:
WO 2012/085702 (28.06.2012 Gazette  2012/26)

(54)

VAGINAL INSERT DEVICE HAVING A SUPPORT PORTION WITH PLURALITY OF FOLDABLE AREAS

VORRICHTUNG ZUM EINSETZEN IN DIE VAGINA MIT EINEM STÜTZTEIL MIT MEHREREN FALTBAREN BEREICHEN

DISPOSITIF À INSÉRER DANS LE VAGIN POSSÉDANT UNE PARTIE SUPPORT POURVUE D'UNE PLURALITÉ DE ZONES PLIABLES


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 23.12.2010 US 977561

(43)Date of publication of application:
30.10.2013 Bulletin 2013/44

(73)Proprietor: Kimberly-Clark Worldwide, Inc.
Neenah, Wisconsin 54956 (US)

(72)Inventors:
  • ELLEFSON, Kimberly, Louise
    Oshkosh WI 54904 (US)
  • BOON, Jason, Robert
    Appleton WI 54911 (US)
  • WOLTMAN, Garry, Roland
    Appleton WI 54911 (US)
  • ZUNKER, MaryAnn
    Oshkosh WI 54904 (US)
  • SAMOLINSKI, Patricia, Ann
    Winneconne WI 54986 (US)
  • BAUER, Walter, George
    Neenah WI 54956 (US)
  • BARAD, Vivian, Kate
    San Francisco CA 94110 (US)
  • KAHN, Nicole, Sarah
    San Francisco CA 94112 (US)
  • ROMERO, Gina, Lynn
    Los Altos CA 94022 (US)
  • OBERWELZ, Elger
    San Francisco CA 94107 (US)
  • YURCHENCO, James, Rolfe
    Palo Alto CA 94303 (US)
  • HOUSTON, Jonah, Lawrence
    San Jose CA 95120 (US)
  • CARD, Tiffany, Heather
    Los Altos Hills California 94022 (US)
  • SCHNITZER, Martin
    San Francisco CA 94110 (US)

(74)Representative: Dehns 
St. Bride's House 10 Salisbury Square
London EC4Y 8JD
London EC4Y 8JD (GB)


(56)References cited: : 
WO-A1-00/37012
US-A- 4 212 301
US-A- 5 036 867
US-A1- 2004 122 285
US-A1- 2008 033 230
WO-A2-2011/080628
US-A- 4 212 301
US-A- 6 142 928
US-A1- 2004 122 285
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    BACKGROUND



    [0001] Female stress urinary incontinence, the involuntary loss of urine, may occur during normal movements and everyday activities including laughing, coughing, sneezing, exercise and any physical activity that causes an increase in intra-abdominal pressure resulting in urine to flow from the bladder through the urethral tube to the outside of the body. The primary causative factor resulting in genuine stress incontinence is the incomplete transmission of abdominal pressure to the proximal urethra due to the displacement of the urethra from its intra-abdominal position. Stress incontinence is related to weakened pelvic floor muscles tissue and ligaments that are no longer able to adequately support the proximal urethra and elevate it above the pelvic floor thereby subjecting it to increases in intra-abdominal pressure, thus allowing compression and maintenance of continence [Urogynecology and Urodynamics - Theory and Practice, chapter 36, page 494]. Stress incontinence may result from repetitive straining of the pelvic muscles, pregnancy, obesity etc. that lead to a loss of pelvic muscle tone and other medical causes that can also occur naturally with the aging process. Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence.

    [0002] As the world's female population ages, there is an ever-increasing need for a consumer friendly, method or measure to reduce the involuntary urine loss commonly associated with stress urinary incontinence. Although there are specialized products available for this purpose, many can only be purchased with a prescription and they need to be properly sized, physically inserted and/or adjusted by a medical practitioner for them to perform correctly. Over the counter solutions like feminine pads and incontinence pads being bulky and exterior to the body are not discreet and do not mitigate the problem before absorbent protection is required.

    [0003] In view of the lack of commercially available devices that are easy to use, there is a need for a urinary incontinence device that can be purchased by the consumer and that is uncomplicated and user friendly. Furthermore, there is a need for a urinary incontinence device that is easy for a woman to insert into and remove from her body that is comfortable to wear and provides both physical and psychological assurance that it is capable of properly performing over an extended period of time.

    [0004] US 4,212,301 discloses a digital tampon capable of being compressed.

    [0005] US 2004/0122285 discloses a urinary incontinence device that deforms and substantially conforms to the shape of the vaginal cavity or cervical fornices.

    [0006] WO 00/37012 discloses a urinary incontinence device including a non-absorbent which at least partially encloses a resilient member.

    [0007] WO 2011/080628 discloses a disposable urinary incontinence device comprising a liquid-stable resilient member and a cover sheet.

    SUMMARY



    [0008] The present invention provides a vaginal insert device as claimed in claim 1. The present invention also provides an apparatus as claimed in claim 10. The present invention further provides a kit as claimed in claim 11. The present invention still further provides a method as claimed in claim 12.

    [0009] Generally, a vaginal insert device used to treat urinary incontinence is disclosed. The vaginal insert device includes a support portion, a stabilizing portion, a removal device, and at least one fluid passageway extending though the support portion. The vaginal insert expands in the vagina to deliver an outward compression force against the bladder neck via the anterior vaginal wall to assist in the prevention of urinary stress incontinence.

    [0010] The substantially cylindrical support portion has a distal end and a proximal end. In addition, the support portion has a plurality of foldable areas that extend from the distal end to the proximal end.

    [0011] The largest outer circumference of the support portion has an insertion diameter when the plurality of foldable areas are compressed and folded inward and an in-use diameter wherein the plurality of foldable areas are extended outward into a maximum in-use diameter position. Desirably, the in-use diameter is larger than the insertion diameter. For example, the in-use diameter of the support portion may range from about 20 to about 60 mm and the insertion diameter of the support portion may range from 10 to about 25 mm.

    [0012] In an exemplary embodiment, the stabilizing portion is attached to the distal end of the support portion. The stabilizing portion provides a means to prevent the vaginal insert device from unintentionally moving, thereby stabilizing the vaginal insert device within the vaginal cavity.

    [0013] In an exemplary embodiment, at least one fluid passageway extends between the plurality of foldable areas.

    [0014] A removal member is be attached to the vaginal insert device. The removal member may be anything known by one skilled in the art to allow a user to remove the vaginal insert device.

    [0015] The support portion of the vaginal insert device has three separate configurations or modes depending on whether the device is being inserted, is in-use or being removed. Accordingly, the support portion has an insertion mode, an in-use mode, and a removal mode. The insertion mode may include the plurality of foldable areas being compressed and folded inward so that the largest outer circumference of the support portion has an insertion diameter.

    [0016] After insertion of the vaginal insert into the vaginal cavity, the plurality of foldable areas expand to a maximum conical shape to transition between the insertion mode and the in-use mode wherein the largest outer circumference of the support portion has an in-use diameter larger than the insertion diameter. Desirably, the largest outer circumference in the in-use mode is at the distal end of the support portion.

    [0017] Desirably, the vaginal insert device may be stored in the insertion mode within an applicator. The applicator maintains the support portion of the vaginal insert device in the insertion mode, and removal of the vaginal insert device from the applicator transitions the support portion from the insertion mode to the in-use mode.

    [0018] In exemplary embodiments, when the vaginal insert device is in the removal mode, the largest outer circumference of the support portion has a removal diameter that is the same size as the in-use diameter. In other embodiments, the support portion becomes elongated when the removal member is activated so that the largest outer circumference of the support portion has a removal diameter smaller than the in-use diameter. Desirably, the removal member comprises a string, and tension on the string compels the support portion to an elongated position in transition between the in-use mode and the removal mode.

    [0019] The vaginal insert device is constructed of a compliable resilient material.

    [0020] In another embodiment, the vaginal insert device includes an absorbent material coupled to the vaginal insert device. In this embodiment, the vaginal insert device acts as both a urinary incontinence device and a tampon.

    [0021] In another embodiment, an apparatus with the vaginal insert device and an applicator coupled to the vaginal insert device for facilitating insertion of the vaginal insert device is disclosed.

    [0022] In another embodiment, a method of manufacturing an apparatus including providing a vaginal insert device as described above, compressing the plurality of foldable areas inward wherein the largest outer circumference of the support portion has an insertion diameter and storing the vaginal insert device within an applicator.

    [0023] In another embodiment, a kit is disclosed having at least a first vaginal insert device as described above and a second vaginal insert device as described above. In this embodiment, the first vaginal insert device comprises a first length and a first in-use diameter and the second vaginal insert device comprises a second length and a second in-use diameter. The second length may be different from the first length, and/or the first in-use diameter may be different from the second in-use diameter. This enables a new user to use different sized vaginal insert devices and determine the proper size for continued use.

    DETAILED DESCRIPTION



    [0024] Generally, a vaginal insert device used to treat urinary incontinence is disclosed. The vaginal insert device includes a support portion, a stabilizing portion, a removal device, and at least one fluid passageway extending though the support portion.

    [0025] A human torso of a female has a vagina, a cervix, a uterus, a urethra, a bladder and a symphysis pubis. The vagina has an introital opening that exits the human body and contains a vaginal canal that extends from the introital opening to the cervix. The vaginal canal has a length that ranges from between about 4 inches to about 6 inches (about 102 to about 153 mm) in most women. The cervix is the entrance to the womb and is located between the upper aspect of the vaginal canal and the uterus. The rectum is located posterior to the vagina. The vaginal canal has an inner periphery.

    [0026] The inner periphery is made up of a right lateral wall, a left lateral wall, an anterior wall, and a posterior wall. The four walls encompass the entire 360 degrees of the inner periphery. The anterior wall is located closest to the urethra and the urethra is located between the symphysis pubis and the vagina.

    [0027] The vaginal canal can be divided into three approximately equal sections, each representing about one-third of the overall length. Each section is approximately 2 inches (approximately 51 mm) in length. The middle third of the vaginal canal is the most important section for alleviating female urinary incontinence because of its proximity to the urethra and is the location where a vaginal insert device should be positioned. The middle third of the vaginal canal is also horizontally offset from the symphysis pubis, which is a bony prominence situated adjacent to a front portion of the human torso and may be referred to as the bladder neck region. Cooperation between a vaginal insert device positioned in the vagina and the symphysis pubis allows the urethra to be compressed upon itself thereby providing a means to alleviate involuntary urine flow from the bladder.

    [0028] The urethra, also referred to as a urethral tube, is a hollow tubular structure that extends from a first opening that exits the human body to a second opening situated at the lower surface of the bladder. The urethra has a length of about 1.5 inches (about 38 mm) in most women. The urethra functions to discharge urine, which is temporarily stored in the bladder, from the human body. The urethra has a plurality of urethral sphincter muscles located along the length of its inner periphery. The urethral sphincter muscles are situated below the opening and are ring like muscles that normally maintain constriction of the urethra to prevent the passage of urine. The relaxation of the urethral sphincter muscles by normal physiological functioning will permit urine to be voluntarily expelled from the body.

    [0029] The human torso further includes musculature and body tissue located in the urethrovaginal myofascial area that is situated between the vagina and the symphysis pubis. The bladder lies posterior to the symphysis pubis and is separated from the rectum by the vagina and the uterus. The ureters which transport urine from the kidneys to the bladder, pass from the pelvis to the posterior aspect of the urinary bladder. The fundus vesicae, into which both of the ureters terminate, is located adjacent to the anterior wall of the vagina.

    [0030] A vaginal insert device according to the invention may be positioned in the vaginal canal and, in particular, in the bladder neck region. The vaginal insert device is designed to bridge across the vagina to support the musculature and body tissue located in the urethra-vaginal myofascial area. In other words, the vaginal insert device and, in particular, the support portion supports the bladder neck to a more normal retropubic position thereby restoring continence.

    [0031] A portion of the vaginal insert device and, in particular, the support portion of the vaginal insert device is directly touching the anterior and posterior walls. Alternatively, the insert can be selectively positioned such that a portion of the top can be touching both the right and left lateral walls (not shown) and the anterior and posterior walls to provide a supportive backdrop for the urethral tube and to support the bladder neck region thereby restoring continence. The urethral tube will now be sufficiently compressed to intercept the flow of urine and to provide support to the urinary sphincter muscle so that it can function properly. By permitting the urethral tube to be compressed upon itself between the vaginal insert device and the symphysis pubis, the involuntary flow of urine from the bladder is limited.

    [0032] The vaginal insert device includes a generally cylindrical support portion, a stabilizing portion, a removal device, and at least one fluid passageway extending though the support portion.

    [0033] The support portion provides for generating urethral support and has a distal end and a proximal end. As used in the specification and claims, the distal end refers to that portion of the vaginal insert device that is first inserted into the vagina. The support portion of the vaginal insert device has three separate configurations or modes depending on whether the device is being inserted, is in-use or being removed. Accordingly, the support portion has an insertion mode, an in-use mode, and a removal mode.

    [0034] In the in-use mode, the support portion has a generally conical shape. The generally conical shape may have a variety of cross-sectional shapes spanning from a five-point flower shaped cross-section, circular cross-section configuration to more of an oval cross-section configuration to more of a square cross-sectional configuration to more of a rectangular cross-sectional configuration. If the support portion has a non-round cross section, the outer circumference of the support portion can be defined by connecting the outermost points of the cross-sectional area. Typically, the outer circumference of the support portion has a substantially round cross-section.

    [0035] In the in-use, the support portion with a distal end and a proximal end expands from the insertion mode to provide a conical shape as the vaginal insert device is inserted into the vaginal cavity. While the support portion is described as being conically shaped, it may also be shaped in the form of a pear, a tear drop, an obconical, or similar shape. Accordingly, the term "conical shape" is meant to include a pear shape, a tear drop shape, an obconical, or similar shape.

    [0036] Each of these shapes have a distal end of the insert having a cross-sectional area that is greater than the cross-sectional area of the proximal end of the support portion. Typically, the proximal end of the vaginal insert device will have a largest outer circumference with an in-use diameter which is larger than any other point on the support portion. Desirably, the support portion has an in-use diameter ranging from about 20 to about 60 mm, preferably about 40 to about 60 mm, or more preferably about 50 mm.

    [0037] In addition, it is preferred that the shape of the vaginal insert device does not present any sharp corners or surfaces but instead is shaped to present rounded or curved surfaces to minimize any discomfort during insertion, use, and removal of the vaginal insert device. Accordingly, the edges of both the distal end and the proximal end of the vaginal insert device are rounded. The rounded edge of the proximal end of the vaginal insert device allows for easier removal.

    [0038] While the vaginal insert device is in the in-use mode, the device, not including the removal member may have a length of from about 10 to about 120 mm, desirably from about 30 to about 90 mm, and most desirably from about 50 to about 70 mm. The largest outer circumference of the device may also have a cross-sectional area from about 10 to about 70 mm, preferably from about 30 to about 60 mm.

    [0039] The support portion includes a plurality of foldable areas extending from the distal end to the proximal end. Desirably, the number of foldable areas extending from the distal end to the proximal end is between 2 and 6, and even more desirably between 4 and 6, such as 5 foldable areas. The plurality of foldable areas extend straight down from the distal end to the proximal end.

    [0040] When the support portion is in the insertion mode, the plurality of foldable areas are compressed or foldable inward. When the plurality of foldable areas are compressed and folded inward, the largest outer circumference of the support portion may have an insertion diameter which allows for easier insertion into the vagina. Typically, the distal end of the support portion will compress to provide a substantially cylindrical shape with a uniform diameter throughout the vaginal insert device.

    [0041] Typically, to allow for easy insertion into the vagina, the insertion diameter is smaller than the in-use diameter. Desirably, the support portion has an insertion diameter ranging from 10 to about 25 mm, preferably about 10 to about 20 mm, or more preferably about 15 to about 20 mm. The smaller insertion diameter of the vaginal insert device provides an easier way to insert the vaginal insert device.

    [0042] The support portion also includes a fluid passageway. The fluid passageway serves two important functions. First, the fluid passageway provides the space necessary in the vaginal insert device to allow for the plurality of foldable areas to compress inward to provide a smaller diameter when in the insertion mode.

    [0043] Secondly, the fluid passageway is provided to facilitate the natural movement of vaginal fluids entering the vaginal insert device. The fluid passageway is defined by the space extending through the support portion from the distal end and terminating at the proximal end. Desirably, there is a fluid passageway for each foldable area.

    [0044] As discussed above, there is a stabilizing portion attached to the distal end of the support portion. The stabilizing portion provides a means to prevent the vaginal insert device from unintentionally moving, thereby stabilizing the vaginal insert device within the vaginal cavity. In an exemplary embodiment of the invention, the stabilizing portion does not apply significant pressure to the wearer's vagina and/or urethra, thereby enhancing comfort. A bulb or cone may be used to provide the stabilizing portion.

    [0045] Other structure known in the art may be provided as a stabilizing portion instead of a bulb to help stabilize the vaginal insert device in the vagina and prevent the device from unintentionally moving. For example, at least one cone, protrusion, extension arm or various shaped stents attached to the support portion could also be used as the stabilizing portion to secure the vaginal insert device within the vaginal cavity.

    [0046] Typically, the stabilizing portion may have a diameter ranging from 10 to about 25 mm, preferably about 10 to about 20 mm, or more preferably about 15 to about 20 mm.

    [0047] In addition, the vaginal insert device also includes a removal member attached to the vaginal insert device. The removal member may be anything known in the art to allow a user to remove the vaginal insert device from the vaginal cavity. The removal member may be a separate piece from the vaginal insert device or may be integrally formed with the vaginal insert device. When the removal member is attached and/or formed with the support portion, pulling on the removal member may cause the support portion to inwardly collapse upon itself to reduce the largest outer circumference of the cross-sectional area of the support portion of the vaginal insert device for easier removal. Preferably, the removal member is connected to a portion of the proximal end of the support portion. The removal member has a shape suitable to be grasped so that the vaginal insert device may be removed. For example, the removal member may be a ring, a hook or a string.

    [0048] The removal member may be formed or attached within or to the support portion so that as the removal member is pulled downward (i.e., in a direction from the distal end toward the proximal end of the vaginal insert device), the distal end of the vaginal insert device is urged downward to follow the proximal end of the vaginal insert device out the vagina. In this embodiment, when the removal member is formed within the support portion and, in particular the fluid passageway, pulling on the removal member will cause the insert to inwardly collapse upon itself to reduce the cross-sectional area of the largest outer circumference area to a removal diameter to provide an exemplary removal mode for the support portion of the vaginal insert device.

    [0049] In other embodiments, the removal member simply acts as a way to remove the vaginal insert device from the vagina. In this exemplary removal mode, the vaginal insert device maintains the same shape and the same cross-sectional area so that the removal diameter is the same as the in-use diameter.

    [0050] The vaginal insert device as described herein may be disposed after a single use, may be worn more than once, or may be reusable for a period of time (e.g., one week) before being disposed.

    [0051] A method of manufacturing the vaginal insert device is also disclosed. The method involves providing a vaginal insert device as described herein having a substantially cylindrical support portion having a distal end and a proximal end. The support portion includes a plurality of foldable areas extending helically from the distal end to the proximal end, a stabilizing portion attached to the distal end of the support portion, at least one fluid passageway extending from the distal end to the proximal end, and a removal member attached to the vaginal insert device.

    [0052] The vaginal insert device is manufactured with a compliable resilient material. As used herein the specification and the claims, the term "resilient material" and variants thereof relate to materials that can be shaped into an initial shape, which initial shape can be subsequently formed into a stable second shape with mechanical deformation such as bending, compressing or twisting the material. The resilient material then substantially reverts to its initial shape when the mechanical deformation ends. The vaginal insert device described herein is formed into the in-use mode as described above. The vaginal insert device can then be mechanically deformed for insertion or storage within an applicator. After the vaginal insert device is inserted, the vaginal insert device is restored back to the in-use mode due to the ability of the resilient material to relax or spring back to its original shape. Shape memory polymers could also be used.

    [0053] Advantageously, the vaginal insert device may be of a unitary construction and may be formed by molding an inert, biocompatible resilient polymer. In any event, the device whether made of unitary construction or otherwise, is made of a suitable biocompatible material, which is known to those of skill in the art. The device may also be covered with a suitable biocompatible outer cover material. Desirably, the compliable resilient material may be formed from a closed cell polyurethane foam.

    [0054] After constructed from the compliable resilient material, the vaginal insert device may then be configured so that the plurality of foldable areas are compressed or foldable inward so that the support portion has an insertion diameter. The vaginal insert device can then be stored within an applicator.

    [0055] In use, the vaginal insert device is provided with the support portion in the insertion mode. Desirably, the vaginal insert device may be stored in the insertion mode within an applicator. The applicator maintains the support portion of the vaginal insert device in the insertion mode, and removal of the vaginal insert device from the applicator transitions the support portion from the insertion mode to the in-use mode after insertion into the vaginal cavity. The insertion mode includes the plurality of foldable areas being compressed or folded inward so that the largest outer circumference of the support portion has an insertion diameter. Alternatively, the user of the vaginal insert device may configure the vaginal insert device manually by compressing the plurality of foldable areas inward prior to insertion with or without an applicator.

    [0056] After insertion of the vaginal insert device into the vaginal cavity, the plurality of foldable areas decompress and expand to a maximum in-use diameter position to transition between the insertion mode and the in-use mode wherein the largest outer circumference of the support portion has an in-use diameter larger than the insertion diameter.

    [0057] When ready for removal, the user will engage the removal member on the vaginal insert device and remove the device from the vagina. When the vaginal insert device is in the removal mode, the largest outer circumference of the support portion may have a removal diameter which is the same size as the in-use diameter. In other embodiments, the support portion may become elongated when the removal member is activated so that the largest outer circumference of the support portion has a removal diameter smaller than the in-use diameter. Desirably, the removal member comprises a string, and tension on the string compels the plurality of foldable areas to an elongated position in transition between the in-use mode and the removal mode to facilitate easier removal.

    [0058] The vaginal insert device may be inserted using an applicator similar to those known in the tampon art. The applicator may be a push-type applicator or a retractable applicator. A collar may be added to control the depth of insertion. The applicator may be dipped in a lubricant and placed into the vagina until the base of the applicator is at the opening of the vagina.

    [0059] After the user orients the applicator, the plunger then is pushed to its maximum extent, or until the subject feels comfortable. The plunger and barrel are then removed from the body.

    [0060] The vaginal insert devices may be enclosed in a flexible bag or covered with a skin that may reduce friction during deployment, help control the device during insertion and removal, help the device to stay in place, and/or create more contact area for applying pressure to the vaginal walls. For example, the vaginal insert device may be enclosed in a vacuum shrink wrap plastic bag for insertion. Any medically appropriate materials may be used to form the bag, and depending upon the desired end-use it may be opaque, light, and/or breathable. Useful bag materials include those used in the manufacture of tampons, such as nonwoven fabrics and plastic film, including apertured films. The bag itself may also be apertured.

    [0061] In exemplary embodiments, the stabilizing portion may be formed integrally with the support portion. In other embodiments, the stabilizing portion may be formed separately from the support portion and attached by an attachment means, such as an adhesive. Similarly, the removal member may be formed integrally with the support portion. In other embodiments, the removal member may be formed separately from the support portion and attached by an attachment means, such as an adhesive.

    [0062] In another exemplary embodiment, the vaginal insert device may also include an absorbent material. The absorbent material may surround the support portion of the vaginal insert device or extend from the distal end of the device. In this embodiment, the vaginal insert device may be used as both a urinary incontinence device and a tampon which can be useful for absorbing body fluid from a woman's vagina, especially during her menstrual cycle. The absorbent material is attached to the vaginal insert device and is designed to be inserted above the introital region of a woman's vagina and is designed to function so as to intercept the fluid flow of menses, blood, and other body fluids, and prevent the fluid from exiting the vagina. It should be noted that, while in use, the vaginal insert device will be entirely positioned within the woman's vagina.

    [0063] The mass of absorbent material can be formed from absorbent fibers which are assembled into an absorbent sheet or ribbon. One exemplary type of sheet for practicing the invention is described in patent application

    [0064] PCT/EP2004/006441 titled: "Airlaid Process With Improved Throughput", filed June 16, 2003, published December 29, 2004 as WO2004/113608. Alternatively, the material can be formed from a general mass of absorbent fibers. In either case, the fibers are then rolled or assembled, respectively, and compressed into a generally cylindrical and elongated shape. Two processes for forming such an absorbent sheet are known as "carding" and "airlaying." Depending upon the desired absorbency one desires in the finished tampon, the basis weight of the absorbent sheet can vary. The U.S. Food and Drug Administration (FDA) has set absorbency standards for "junior", "regular", "super", "super-plus" and "super-plus-plus" size tampons. In order to meet the certain standards for these sizes, the absorbent sheets are targeted to have basis weights of about 100 grams per square meter (gsm), 120-150 gsm, 170-180 gsm, 210-230 gsm, and 240-260 gsm, respectively, and as much as 270-290 gsm. Typically, the formation process is controlled to produce an absorbent sheet with a width of between about 40 to about 60 mm, preferably about 50 mm. The basis weight and/or the length of the absorbent materials may also be adjusted to form the different size inserts.

    [0065] The absorbent material is a plurality of fibers which are capable of absorbing. The first type of fiber (also referred to generally herein as binder fiber) is bondable to fibers of the plurality of fibers. Additionally, the plurality of fibers may be a homogeneous mixture of the types of fibers and additionally, or alternatively, the second type of fiber may have a material composition different than the first type of fiber. For example, the bondable first type of fibers may be polymer fibers. Material includes a second type of fiber which may be cellulosic fibers such as wood pulp, cotton, rayon, viscose, LYOCELL® which is from Lenzing Company of Austria, or mixtures of these or other cellulosic fibers. The second type fiber may be a natural type fiber and/or it may not be autogenously bondable to other like type fibers. The absorbent material can be a blend of viscose and binder fibers. Some blends which are believed to work well include a blend of about 70% viscose to about 95% viscose with the remainder about 30% binder fiber to about 5% binder fiber; and more advantageously about 85-90% viscose and the remainder about 15-10% binder fiber. The particular blend of fibers can vary depending upon one's preference in combination with also achieving the features of the invention.

    [0066] More specifically, for example, the plurality of fibers could be either synthetic fibers or natural fibers, as long as they have the desired absorbent and/or bondable characteristics. Synthetic fibers include those made from polyolefins, polyamides, polyesters, rayon, acrylics, viscose, superabsorbents, LYOCELL® regenerated cellulose and any other suitable synthetic fibers known to those skilled in the art. Many polyolefins are available for fiber production, for example polyethylenes such as Dow Chemical's ASPUN® 6811A linear low density polyethylene, 2553 LLDPE and 25355 and 12350 high density polyethylene are such suitable polymers. The polyethylenes have melt flow rates, respectively, of about 26, 40, 25 and 12. Fiber forming polypropylenes include Exxon Chemical Company's ESCORENE® PD 3445 polypropylene and Montell Chemical Co.'s PF304. Another fiber could be a bi-component polyester sheath and polyethylene core and known as T255 made by Trevira of Germany. Other polyolefins are also available. Suitable rayon fibers are 1.5 denier Merge 18453 fibers from Acordis Cellulose Fibers Incorporated of Axis, Alabama. The fibers can be treated by conventional compositions and/or processes to enable or enhance wettability.

    [0067] Natural fibers can include wool, cotton, flax, hemp and wood pulp. Wood pulps include standard softwood fluffing grade such as CR-1654 (US Alliance Pulp Mills, Coosa, Alabama). Pulp may be modified in order to enhance the inherent characteristics of the fibers and their processability. Crimping may be imparted to the fibers, e.g., by conventional means. Curl may be imparted to the fibers, e.g., by methods including chemical treatment or mechanical twisting. Curl is typically imparted before crosslinking or stiffening. Pulps may be stiffened by the use of crosslinking agents such as formaldehyde or its derivatives, glutaraldehyde, epichlorohydrin, methylated compounds such as urea or urea derivatives, dialdehydes such as maleic anhydride, non-methylated urea derivatives, citric acid or other polycarboxylic acids. Some of these agents are less preferable than others due to environmental and health concerns. Pulp may also be stiffened by the use of heat or caustic treatments such as mercerization. Examples of these types of fibers include NHB416 which is a chemically crosslinked southern softwood pulp fiber which enhances wet modulus, available from the Weyerhaeuser Corporation of Tacoma, Washington. Other useful pulps are debonded pulp (NF405) and non-debonded pulp (NB416) also from Weyerhaeuser. HPZ3 from Buckeye Technologies, Inc of Memphis, Tennessee, has a chemical treatment that sets in a curl and twist, in addition to imparting added dry and wet stiffness and resilience to the fiber. Another suitable pulp is Buckeye HP2 pulp and still another is IP Supersoft from International Paper Corporation.

    [0068] For the cellulosic fiber (e.g., viscose, rayon, etc.), the fibers should have a staple length of between about 5 to about 35 mm. The fibers should have a denier of between about 2 to about 6. Denier is a unit of fineness of yarn based on a standard of 50 milligrams (mg) for 450 meters of yarn. The fibers can have a circular, a bi-lobal, a tri-lobal cross-sectional configuration, or some other cross-sectional configuration known to those skilled in the art. The bi-lobal configuration has a cross-sectional profile which looks like a dog bone while the tri-lobal configuration has a cross-sectional profile which looks like a "Y". The fibers can also be bleached if desired.

    [0069] When cotton fibers are used, the cotton fibers should have a staple length of between about 5 to about 20 mm. The cotton fibers should generally have a fiber size of between about 150 to about 280 microns. The cotton fibers can also be bleached if desired. Bleaching will make the cotton fibers whiter in appearance.

    [0070] In another embodiment, there is a kit containing at least two vaginal inserts devices as described herein. In this kit, the first vaginal insert device may have a first length and a first in-use diameter and the second vaginal insert device has a second length and a second in-use diameter. The second length is different from the first length, and the first in-use diameter is different from the second in-use diameter to allow a user to determine the size of vaginal insert device to be used.

    [0071] Other modifications and variations to the appended claims may be practiced by those of ordinary skill in the art, without departing from the spirit and scope as set forth in the appended claims. It is understood that features of the various examples may be interchanged in whole or part. The preceding description, given by way of example in order to enable one of ordinary skill in the art to practice the claimed invention, is not to be construed as limiting the scope of the invention, which is defined by the claims.


    Claims

    1. A vaginal insert device comprising:

    a support portion having a distal end and a proximal end, the support portion having a plurality of foldable areas extending from the distal end to the proximal end, wherein the largest outer circumference of the support portion has an insertion diameter when the plurality of foldable areas are compressed and folded inward into an insertion position;

    a stabilizing portion attached to the distal end of the support portion;
    a plurality of fluid passageways each defined by a space extending through the support portion from the distal end and terminating at the proximal end of the support portion; and

    a removal member attached to the vaginal insert device;
    wherein the vaginal insert device comprises a compliable resilient material such that it can be shaped into an initial shape, which initial shape can subsequently be formed into a stable second shape with mechanical deformation, wherein the compliable resilient material substantially reverts to its initial shape when the mechanical defomation ends, wherein vaginal insert device is in the stable second shape in the insertion position;

    wherein the plurality of foldable areas extend straight down from the distal end to the proximal end, wherein the plurality of passageways provide space for the plurality of foldable areas to compress inward into the insertion position.


     
    2. The vaginal insert device of claim 1, wherein the distal end has a cross-sectional area that is greater than a cross-sectional area of the proximal end, and the proximal end has a largest outer circumference with an in-use diameter which is larger than any other point on the support portion in an in-use mode.
     
    3. The vaginal insert device of claim 1 or 2, wherein the largest outer circumference of the support portion has an in-use diameter wherein the plurality of foldable areas are extended outward and form a conical shape, wherein the in-use diameter is larger than the insertion diameter.
     
    4. The vaginal insert device of claim 1, 2 or 3, wherein the in-use diameter of the support portion ranges from about 20 to about 60 mm and the insertion diameter of the support portion ranges from 10 to about 25 mm.
     
    5. The vaginal insert device of any one of claims 1-4, wherein the device further comprises an absorbent material coupled to the vaginal insert device.
     
    6. The vaginal insert device of any one of claims 1-5, wherein there is a fluid passageway for each foldable area.
     
    7. The vaginal insert device of any one of claims 1-6, wherein the support portion having an insertion mode wherein a largest outer circumference of the support portion has an insertion diameter when the plurality of foldable areas are compressed; the support portion having an in-use mode wherein the largest outer circumference of the support portion has an in-use diameter larger than the insertion diameter, and the support portion having a removal mode.
     
    8. The vaginal insert device of any one of claims 1-7, wherein the insertion mode comprises the plurality of foldable areas compress inward; and/or
    wherein the plurality of foldable areas expand to a maximum in-use diameter position to transition between the insertion mode and the in-use mode; and/or wherein the removal mode comprises the support portion in an elongated position wherein the largest outer circumference of the support portion has a removal diameter smaller than the in use diameter.
     
    9. The vaginal insert device of any one of claims 1-8, wherein the removal member comprises a string; and
    tension on the string compels the support portion to an elongated position in transition between the in-use mode and the removal mode.
     
    10. An apparatus comprising:

    the vaginal insert device of any one of claims 1-9; and

    an applicator coupled to the vaginal insert device for facilitating insertion of the vaginal insert device.


     
    11. A kit comprising:

    at least a first vaginal insert device of any of claims 1-9, and a second vaginal insert device of any one of claims 1-9;

    wherein the first vaginal insert device comprises a first length and a first in-use diameter;

    wherein the second vaginal insert device comprises a second length and a second in-use diameter;

    wherein the second length is different from the first length, and the first in-use diameter is different from the second in-use diameter.


     
    12. A method of manufacturing the apparatus of claim 10 comprising:

    providing a vaginal insert device comprising a substantially conical support portion having a distal end and a proximal end, the support portion having a plurality of foldable areas extending from the distal end to the proximal end, a stabilizing portion attached to the distal end of the support portion, a plurality of fluid passageways each defined by a space extending through the support portion from the distal end and terminating at the proximal end, and a removal member attached to the vaginal insert device;

    compressing the plurality of foldable areas inward wherein a largest outer circumference of the support portion has an insertion diameter; and

    storing the vaginal insert device within an applicator.


     


    Ansprüche

    1. Vorrichtung zum Einführen in die Vagina, Folgendes umfassend:

    einen Stützabschnitt mit einem distalen Ende und einem proximalen Ende, wobei der Stützabschnitt eine Vielzahl von faltbaren Bereichen aufweist, die sich von dem distalen Ende zum proximalen Ende erstrecken, wobei der größte Außenumfang des Stützabschnitts einen Einführdurchmesser aufweist, wenn die Vielzahl von faltbaren Bereichen zusammengedrückt und in eine Einführposition nach innen gefaltet sind;

    einen Stabilisierungsabschnitt, der an dem distalen Ende des Stützabschnitts befestigt ist;

    eine Vielzahl von Fluiddurchgängen, die jeweils durch einen Raum definiert sind, der sich durch den Stützabschnitt von dem distalen Ende erstreckt und an dem proximalen Ende des Stützabschnitts endet; und

    ein Entnahmeelement, das an der Vorrichtung zum Einführen in die Vagina befestigt ist;

    wobei die Vorrichtung zum Einführen in die Vagina ein nachgiebiges elastisches Material derart umfasst, dass sie eine Ausgangsform aufweist, wobei die Ausgangsform anschließend bei mechanischer Verformung in eine stabile zweite Form gebracht werden kann, wobei das nachgiebige elastische Material im Wesentlichen in seine Ausgangsform zurückkehrt, wenn die mechanische Verformung endet; wobei die Vorrichtung zum Einführen in die Vagina in der stabilen zweiten Form in der Einführposition ist;

    wobei die Vielzahl der faltbaren Bereiche sich direkt nach unten von dem distalen Ende zum proximalen Ende erstrecken, wobei die Vielzahl von Durchgängen einen Raum für die Vielzahl von faltbaren Bereichen bereitstellen, um sie in die Einführposition nach innen zusammenzudrücken.


     
    2. Vorrichtung zum Einführen in die Vagina nach Anspruch 1, wobei das distale Ende eine Querschnittsfläche aufweist, die größer ist als eine Querschnittsfläche des proximalen Endes, und wobei das proximale Ende einen größten Außenumfang mit einem Gebrauchsdurchmesser aufweist, der größer ist als jeder andere Punkt auf dem Stützabschnitt in einem Gebrauchsmodus.
     
    3. Vorrichtung zum Einführen in die Vagina nach Anspruch 1 oder 2, wobei der größte Außenumfang des Stützabschnitts einen Gebrauchsdurchmesser aufweist, wobei die Vielzahl von faltbaren Bereichen sich nach außen erstrecken und eine konische Form bilden, wobei der Gebrauchsdurchmesser größer ist als der Einführdurchmesser.
     
    4. Vorrichtung zum Einführen in die Vagina nach Anspruch 1, 2 oder 3, wobei der Gebrauchsdurchmesser des Stützabschnitts im Bereich von etwa 20 bis etwa 60 mm liegt und der Einführdurchmesser des Stützabschnitts im Bereich von 10 bis etwa 25 mm liegt.
     
    5. Vorrichtung zum Einführen in die Vagina nach einem der Ansprüche 1 bis 4, wobei die Vorrichtung ferner ein saugfähiges Material umfasst, das mit der Vorrichtung zum Einführen in die Vagina gekoppelt ist.
     
    6. Vorrichtung zum Einführen in die Vagina nach einem der Ansprüche 1 bis 5, wobei für jeden faltbaren Bereich ein Fluiddurchgang vorhanden ist.
     
    7. Vorrichtung zum Einführen in die Vagina nach einem der Ansprüche 1 bis 6, wobei der Stützabschnitt einen Einführmodus aufweist, wobei ein größter Außenumfang des Stützabschnitts einen Einführdurchmesser aufweist, wenn die Vielzahl von faltbaren Bereichen zusammengedrückt sind; wobei der Stützabschnitt einen Gebrauchsmodus aufweist, wobei der größte Außenumfang des Stützabschnitts einen Gebrauchsdurchmesser hat, der größer ist als der Einführdurchmesser, und der Stützabschnitt einen Entnahmemodus aufweist.
     
    8. Vorrichtung zum Einführen in die Vagina nach einem der Ansprüche 1 bis 7, wobei der Einfügungsmodus die Vielzahl von faltbaren Bereichen umfasst, die nach innen zusammengedrückt werden; und/oder
    wobei die Vielzahl von faltbaren Bereichen sich auf eine maximale Gebrauchsdurchmesserposition zum Übergang zwischen dem Einführmodus und dem Gebrauchsmodus ausdehnt, und/oder wobei der Entnahmemodus den Stützabschnitt in einer länglichen Position umfasst, wobei der größte Außenumfang des Stützabschnitts einen Entnahmedurchmesser aufweist, der kleiner als der Gebrauchsdurchmesser ist.
     
    9. Vorrichtung zum Einführen in die Vagina nach einem der Ansprüche 1 bis 8, wobei das Entnahmeelement einen Faden aufweist; und
    wobei die Spannung des Fadens den Stützabschnitt in eine längliche Position im Übergang zwischen dem Gebrauchsmodus und dem Entnahmemodus zwingt.
     
    10. Vorrichtung, Folgendes umfassend:

    die Vorrichtung zum Einführen in die Vagina nach einem der Ansprüche 1 bis 9; und

    einen Applikator, der mit der Vorrichtung zum Einführen in die Vagina gekoppelt ist, um das Einführen der Vorrichtung zum Einführen in die Vagina zu erleichtern.


     
    11. Kit, Folgendes umfassend:

    zumindest eine erste Vorrichtung zum Einführen in die Vagina nach einem der Ansprüche 1 bis 9 und eine zweite Vorrichtung zum Einführen in die Vagina nach einem der Ansprüche 1 bis 9;

    wobei die erste Vorrichtung zum Einführen in die Vagina eine erste Länge und einen ersten Gebrauchsdurchmesser umfasst;

    wobei die zweite Vorrichtung zum Einführen in die Vagina eine zweite Länge und einen zweiten Gebrauchsdurchmesser umfasst;

    wobei die zweite Länge sich von der ersten Länge unterscheidet, und der erste Gebrauchsdurchmesser sich von dem zweiten Gebrauchsdurchmesser unterscheidet.


     
    12. Verfahren zur Herstellung der Vorrichtung nach Anspruch 10, Folgendes umfassend:

    Bereitstellen einer Vorrichtung zum Einführen in die Vagina, umfassend einen im Wesentlichen konischen Stützabschnitt mit einem distalen Ende und einem proximalen Ende, wobei der Stützabschnitt eine Vielzahl von faltbaren Bereichen aufweist, die sich vom distalen Ende zum proximalen Ende erstrecken, einen stabilisierenden Abschnitt, der am distalen Ende des Stützabschnitts befestigt ist, zumindest eine Vielzahl an Fluiddurchgängen, die durch jeweils einen Raum definiert sind, der sich durch den Stützabschnitt von dem distalen Ende erstreckt und an dem proximalen Ende des Stützabschnitts endet; und ein Entnahmeelement, das an der Vorrichtung zum Einführen in die Vagina befestigt ist;

    Zusammendrücken der Vielzahl von faltbaren Bereichen nach innen, wobei ein größter Außenumfang des Stützabschnitts einen Einführdurchmesser aufweist; und

    Aufbewahren der Vorrichtung zum Einführen in die Vagina in einem Applikator.


     


    Revendications

    1. Dispositif d'insertion vaginale comprenant :

    une partie de support ayant une extrémité distale et une extrémité proximale, la partie de support ayant une pluralité de zones pliables s'étendant à partir de l'extrémité distale à l'extrémité proximale, dans laquelle la circonférence externe la plus grande de la partie de support a un diamètre d'insertion lorsque la pluralité de zones pliables sont comprimées et pliées vers l'intérieur dans une position d'insertion ;

    une partie de stabilisation attachée à l'extrémité distale de la partie de support ;

    une pluralité de passages de fluide, chacun étant défini par un espace s'étendant à travers la partie de support à partir de l'extrémité distale et se terminant à l'extrémité proximale de la partie de support ; et

    un élément de retrait attaché au dispositif d'insertion vaginale ;

    dans lequel le dispositif d'insertion vaginale comprend un matériau élastique souple de sorte qu'il peut être façonné dans une forme initiale, laquelle forme initiale peut ensuite être formée en une deuxième forme stable avec une déformation mécanique, dans lequel le matériau élastique souple revient sensiblement à sa forme initiale lorsque la déformation mécanique se termine, dans laquelle le dispositif d'insertion vaginale est dans la deuxième forme stable dans la position d'insertion ;

    dans lequel la pluralité de zones pliables s'étend tout droit à partir de l'extrémité distale à l'extrémité proximale, dans lequel la pluralité de passages fournit de l'espace pour la pluralité de zones pliables afin de se comprimer vers l'intérieur dans la position d'insertion.


     
    2. Dispositif d'insertion vaginale selon la revendication 1, dans lequel l'extrémité distale a une zone transversale qui est plus grande qu'une zone transversale de l'extrémité proximale, et l'extrémité proximale a une circonférence externe plus grande avec un diamètre en utilisation qui est plus grand que n'importe quel autre point de la partie de support dans un mode en utilisation.
     
    3. Dispositif d'insertion vaginale selon la revendication 1 ou 2, dans lequel la plus grande circonférence externe de la partie de support a un diamètre en utilisation dans lequel la pluralité de zones pliables sont étendues vers l'extérieur et forment une forme conique, dans laquelle le diamètre en utilisation est plus grand que le diamètre d'insertion.
     
    4. Dispositif d'insertion vaginale selon les revendications 1, 2 ou 3, dans lequel le diamètre en utilisation de la partie de support varie d'environ 20 à environ 60 mm et le diamètre d'insertion de la partie de support varie de 10 à environ 25 mm.
     
    5. Dispositif d'insertion vaginale selon l'une quelconque des revendications 1-4, dans lequel le dispositif comprend en outre un matériau absorbant couplé au dispositif d'insertion vaginale.
     
    6. Dispositif d'insertion vaginale selon l'une quelconque des revendications 1-5, dans lequel il existe un passage de fluide pour chaque zone pliable.
     
    7. Dispositif d'insertion vaginale selon l'une quelconque des revendications 1-6, dans lequel la partie de support a un mode d'insertion dans lequel une circonférence externe la plus grande de la partie de support à un diamètre d'insertion lorsque la pluralité de zones pliables sont compressées ; la partie de support a un mode en utilisation dans lequel la circonférence externe la plus grande de la partie de support à un diamètre en utilisation plus grand que le diamètre d'insertion, et la partie de support a un mode de retrait.
     
    8. Dispositif d'insertion vaginale selon l'une quelconque des revendications 1-7, dans lequel le mode d'insertion comprend la pluralité de zones pliables comprimées vers l'intérieur ; et/ ou
    dans lequel la pluralité de zones pliables s'étend à une position de diamètre maximum en utilisation pour transiter entre le mode d'insertion et le mode en utilisation ; et/ ou dans lequel le mode de retrait comprend la partie de support dans une position allongée, dans laquelle la circonférence externe la plus grande de la partie de support a un diamètre de retrait plus petit que le diamètre en utilisation.
     
    9. Dispositif d'insertion vaginal selon l'une quelconque des revendications 1-8, dans lequel l'élément de retrait comprend une ficelle ; et
    la tension sur la ficelle force la partie de support dans une position allongée en transition entre le mode en utilisation et le mode de retrait.
     
    10. Appareil comprenant :

    le dispositif d'insertion vaginale selon l'une quelconque des revendications 1-9 ; et

    un applicateur couplé au dispositif d'insertion vaginale pour la facilitation de l'insertion du dispositif d'insertion vaginale.


     
    11. Kit comprenant :

    au moins un dispositif d'insertion vaginale selon l'une quelconque des revendications 1-9, et un deuxième dispositif d'insertion vaginale selon l'une quelconque des revendications 1-9 ;

    dans lequel le premier dispositif d'insertion vaginale comprend une première longueur et un premier diamètre en utilisation ;

    dans lequel le deuxième dispositif d'insertion vaginale comprend une deuxième longueur et un deuxième diamètre en utilisation ;

    dans lequel la deuxième longueur est différente de la première longueur, et le premier diamètre en utilisation est différent du deuxième diamètre en utilisation.


     
    12. Procédé de fabrication de l'appareil selon la revendication 10 comprenant :

    la fourniture d'un dispositif d'insertion vaginale comprenant une partie de support sensiblement conique ayant une extrémité distale et une extrémité proximale, la partie de support ayant une pluralité de zones pliables s'étendant à partir de l'extrémité distale à l'extrémité proximale, une partie de stabilisation attachée à l'extrémité distale de la partie de support, une pluralité de passages de fluide chacun défini par un espace s'étendant à travers la partie de support à partir de l'extrémité distale et se terminant à l'extrémité proximale, et un élément de retrait attaché au dispositif d'insertion vaginale ;

    la compression de la pluralité de zones pliables vers l'intérieur dans laquelle une circonférence la plus grande de la partie de support a un diamètre d'insertion ; et

    le stockage du dispositif d'insertion vaginale dans un applicateur.


     






    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description