Abstract: Pelvic implant having a frame with two arms and a sheet are disclosed. The sheet may be held under tension in the assembled implant. The implant may be planar (flat) or may be non-planar. The implant may be contoured laterally. A curved non-planar implant may be convex or concave in a rostro-caudal direction. The implants may (optionally) include two additional arms and a second sheet for supporting a urethra and/or a bladder neck. Methods for constructing and assembling the implants are disclosed. A method ultrasonically welding the frame of the implant without thermally damaging the sheet is disclosed. Methods of implantation of the implants are disclosed.

Abstract: In some aspects, the present invention provides surgical procedures that comprise applying compositions into and/or onto tissue, including supporting tissues (e.g., ligaments, connective tissue, muscles, etc.) for pelvic organs, among other tissues. In other aspects, the present disclosure pertains to compositions that are useful for performing such procedures. In still other aspects, the present disclosure pertains to kits that are useful for performing such procedures.

Abstract: A self-expanding retractor is described for placement within the vaginal canal of a post-partum female to aid in performing a vaginal repair. The retractor provides improved exposure and enhanced visualization of an episiotomy or vaginal laceration repair site. The retractor is typically in the form of a foldable, trapezoidal frame defining a central aperture, and includes anterior stability posts at its corners and a panel spanning the central aperture. The panel is typically in the form of a surgical gauze pad for absorbing blood and fluids entering the surgical field. The retractor can be folded by a user for placement within the vaginal canal and then released, which allows it to expand to hold back swollen tissues from obstructing the repair site. The retractor is typically lightweight and compact and is configured to minimize slippage during use.

Abstract: A device sized and shaped for alleviating pelvic organ prolapse when inserted into a vagina, comprising: a treatment rendering portion configured to be adjustable between a first, collapsed state and a second, expanded state, where the second expanded state extends substantially in three dimensions.

Abstract: The present invention provides a vaginal pessary that offers mid-urethral support and is anchored proximate the cervix by a proximal annulus engaging opposing walls of the vagina and supporting a distal annulus engaging opposing walls of the vagina posterior to the mid-urethra. The proximal and distal annulus are joined by compressible cross rods compressible to reduce a diameter of at least one of the proximal and distal annuli.

Abstract: The present invention relates to, in part, methods of improved healthcare in female subjects that, for example, relay on menstrual fluid sampling for long tem biomarker monitoring.

Abstract: An incontinence device is used to apply supporting pressure to an anterior wall of an inferior third of a vaginal canal in the approximate plane of a pubococcygeal muscle and ultimately to a urethra for controlling incontinence. The incontinence device includes a first member having a first end and second end, as well as a second member resiliently connected to the first member. The second member is biased outwardly from the first member to direct the first end of the first member toward the anterior wall of the vaginal canal in a manner providing a support structure transferring upward force for support of the urethra by the first end of the first member.

Abstract: An implant adapted to treat urinary incontinence includes a support material, a suture, and an anchor. The support material is provided to support the urethra when implanted in a patient. The suture is inserted through the support material and includes a first trailing end portion and a second trailing end portion. The anchor has a body, a fin extending from the body with an eyelet formed in the fin and the suture passed through the eyelet of the fin, and a gripping tab removably attached to the fin. The gripping tab is removable from the fin prior to insertion of the anchor into tissue.

Abstract: According to an aspect, a medical device includes a base member and an adjustment member. The adjustment member is movably coupled to the base member. The adjustment member has a body portion and a coupling portion. The coupling portion is configured to couple a medical tool to the adjustment member.

Abstract: A compactable vaginal pessary for managing pelvic organ prolapse is provided. The compactable pessary easily expands once inside a patient's vagina, remaining firmly anchored in the vaginal cavity during movement, thereby effectively countering the effects of any prolapsing organ. In a first embodiment, the vaginal pessary employs an expandable and collapsible frame member, while in a second embodiment; the frame member is an open, substantially cone-shaped, collapsible frame member that is biased to an open position. In a third embodiment, the compactable vaginal pessary is a yieldably extensible, self-retracting pessary. The vaginal pessary of the present invention may be easily inserted and removed by a patient on a daily basis, or as needed, thereby facilitating good hygiene and thus reducing or eliminating common pessary related complications.

Abstract: A folding menstrual cup comprising an outer cup body with a top accommodating cavity formed therein and a round opening provided on the top thereof and the bottom thereof being connected with a flow guiding pipe via a folding part at the side opposite to the opening; a flow guiding pipe providing with a pipe orifice communicating with the top accommodating cavity and a valve controlling communication to the pipe orifice; and a folding part being capable of protruding upward and enabling the top end of the flow guiding pipe to extend into the top accommodating cavity along with the folding part, and capable of straightening downward thereby a bottom accommodating cavity is formed inside the folding part. When in use, the folding part extends into the top accommodating cavity of the outer cup body and is placed in a body.

Abstract: In accordance with embodiments of the present disclosure, a flexible and non-absorbent vaginal insert device shaped to be held securely in place in a vagina when inserted, so as to improve symptoms associated with pelvic organ prolapse or urinary incontinence or both, is provided. The device is designed to be relatively easy to insert and remove. An applicator may be used to aid with insertion. The vaginal insert device comprises an upper portion, having a cone-shaped body, having a circular transverse cross-section throughout its length, having a wall with an interior side and an exterior side, an upper open end, a lower end, and a hollow interior, wherein the upper open end of the upper portion is the innermost portion of the device during insertion, and wherein the wall of the upper portion can be squeezed to make the upper portion more compact for easier insertion of the device, and wherein after insertion the wall expands back to its original shape.

Abstract: The present invention relates to methods of assembling a withdrawal cord with an intravaginal member. In some embodiments, the withdrawal cord is affixed to an intravaginal member through the use of an anchor.

Abstract: An implant configured to treat prolapse of a pelvic organ includes a support member and an extension portion projecting from the support member. The extension portion has a barbed fixation means provided thereon for anchoring the extension portion into pelvic paravaginal tissue. The barbed fixation means allow bi-directional adjustment of the barbed fixation means relative to the tissue, and when suitably located, the barbed fixation means engage the tissue. The support member comprises a mesh material having a mass density of less than 50 g/m2.

Abstract: This application relates to a method of covering a pessary device for relief of female incontinence with an overwrap. More particularly, the present invention relates to methods of conforming the overwrap to the pessary device.

Abstract: A medical device includes a first end portion, a second end portion, and medial portion disposed between the first end portion and the second end portion. The first end portion defines a first axis. The second end portion defines a second axis. The first axis is disposed at an angle with respect to the second axis.

Abstract: An intravaginal device having an aperture and a withdrawal assembly. The withdrawal assembly has a withdrawal member and an obstruction.

Abstract: A fornix manipulator includes a collar and stabilizer. The collar has a first end and a second end, the second end having an opening and diameter greater than the first end and the first end having an opening to receive a cervix into the collar. The stabilizer has a base portion defining a guide hole and a plurality of prongs extending from the base portion to contact the first end of the collar.

Abstract: An apparatus for treating urinary incontinence with a support section adapted for providing urethral support; an anchoring section for resisting movement of the apparatus; an insert, a portion of which is adapted to be positioned where the support section attaches to the node; and, wherein the insert urges the support section radially outwards from a central axis of the apparatus.

Abstract: Surgical procedures, systems, implants, devices, tools, and methods that are used for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to tissue, adjusting the length of implant components, and cutting the implant to a desired length.

Abstract: This application relates to a method of covering a pessary device for relief of female incontinence with an overwrap. More particularly, the present invention relates to methods of overwrapping the pessary device.

Abstract: A medical device and a method for manipulating bodily tissues are described. The medical device includes an elongated portion having a proximal end portion and a distal end portion. The elongated portion has a defined width referred to as first width. The medical device further includes a head portion extending from the distal end portion of the elongated portion. The head portion includes a first flat surface on a first side and a second flat surface on a second side opposite the first side. The head portion has a defined width referred to as second width. The second width is greater than the first width.

Abstract: Disclosed is an intra-vaginal device of a new and innovative design that in combination with kegel exercises or performing ones daily routine strengthens the muscles of the pelvic floor. The device employs a combination of unique shape, materials as well as carefully engineered deflection, frictional, testing and clean-ability characteristics with particular attention to a sexually neutral appearance, comfort during insertion and exercise as well as positive physical feedback to encourage prolonged and frequent use. Benefits of the device include improvement or prevention of urinary leakage and prolapse, increases in sexual intensity, to keep the uterus, bladder or rectum in place as a pessary as well as relief for women suffering from moderate prolapse. As a dilator to aid women who suffer from vaginismus. With its multiple features and benefits, the device is a vital tool in a woman's quest for a complete and balanced wellness regimen.

Abstract: An implant configured to treat prolapse of a pelvic organ includes a support member and an extension portion projecting from the support member. The extension portion has a barbed fixation means provided thereon for anchoring the extension portion into pelvic paravaginal tissue. The barbed fixation means allow bi-directional adjustment of the barbed fixation means relative to the tissue, and when suitably located, the barbed fixation means engage the tissue. The support member comprises a mesh material having a mass density of less than 50 g/m2.

Abstract: A non-expandable pessary device, the pessary device having a top, a base, a length, a longitudinal axis, a maximum diameter, and a minimum diameter that is less than the maximum diameter. The pessary device has a pressure region adapted to extend between an anterior vaginal wall and a posterior vaginal wall of a user to provide pressure on the user's urethra through the vaginal wall. The pressure region includes the maximum diameter, and the maximum diameter is less than 25 mm.

Abstract: This application relates to a method of covering a pessary device for relief of female incontinence with an overwrap. More particularly, the present invention relates to methods of overwrapping the pessary device.

Abstract: A hernia repair implant includes a first layer for facing a body structure having a hernia defect to cover the defect while promoting tissue growth into the first layer from the body structure. The implant also includes a second layer opposed to the first layer and made of anti-adhesion material to prevent growth of tissue into the second layer from body structures contacting the second layer. Furthermore, the implant includes at least one engagement strap connected to the first layer and extending therefrom to terminate at a free end. The engagement strap defines opposed thin edges and opposed flat surfaces extending between the edges. At least one barb extends from at least one edge and/or at least one flat surface of the strap and is configured to impede motion of the strap in only a single direction.

Abstract: In some embodiments, an apparatus includes a handle and an elongate member coupled to the handle. The elongate member has a first portion, a second portion and a third portion. The first portion of the elongate member extends from the handle and defines a first longitudinal axis. The second portion of the elongate member extends from the first portion and defines a second longitudinal axis. The first longitudinal axis and the second longitudinal axis define a first angle and a first plane. The third portion of the elongate member extends from the second portion of the elongate member and defines a third longitudinal axis. The third longitudinal axis and the second longitudinal axis define a second angle and a second plane. The second plane is non-parallel with the first plane.

Abstract: A non-expandable pessary device, the pessary device having a top, a base, a length, a longitudinal axis, a maximum diameter, and a minimum diameter that is less than the maximum diameter. The pessary device has a pressure region adapted to extend between an anterior vaginal wall and a posterior vaginal wall of a user to provide pressure on the user's urethra through the vaginal wall. The pressure region includes the maximum diameter, and the maximum diameter is less than 25 mm.

Abstract: This application relates to a method of covering a pessary device for relief of female incontinence with an overwrap. More particularly, the present invention relates to methods of overwrapping the pessary device.

Abstract: A pessary having a main stem and an inflatable bladder disposed about the proximal larger diameter section of the main stem. The main stem further provides a distal smaller diameter portion having a cap at its distal tip and a check valve disposed there under. The check valve communicates with a central fluid passage that may extend into the proximal larger diameter section of the main stem. Secondary fluid passages connect the central fluid passage to the inflatable bladder volume disposed about the outer circumference of the proximal larger diameter section of the main stem. The main stem provides support to the pelvic structures and the inflatable bladder acts to hold the device in position. At least one void through the proximal larger diameter portion of the main stem allows bodily material to pass from the vagina through the pessary device thereby decreasing the amount of vaginal discharge.

Abstract: There is provided a device for measuring an inside shape of a vagina, including a device body, operationally connected to one or more movable cheeks, the cheeks movable in a direction substantially transaxially relative to the device body longitudinal axis, and a width indicator, for indicating a distance between opposite faces of the cheeks. There is provided a method for fitting a pessary including inserting a Pessary Caliber (PC) into a vagina, extending cheeks of the PC to press against sides of the vagina, measuring a distance between the cheeks, measuring how deep the PC is inserted into the vagina, and selecting a pessary size based, at least in part, on the measuring. Related apparatus and methods are also described.

Abstract: An intravaginal device having an aperture and a withdrawal assembly. The withdrawal assembly has a withdrawal member and an obstruction.

Abstract: A fornix manipulator includes a collar and stabilizer. The collar has a first end and a second end, the second end having an opening and diameter greater than the first end and the first end having an opening to receive a cervix into the collar. The stabilizer has a base portion defining a guide hole and a plurality of prongs extending from the base portion to contact the first end of the collar.

Abstract: In some aspects, the present invention provides surgical procedures that comprise applying compositions into and/or onto tissue, including supporting tissues (e.g., ligaments, connective tissue, muscles, etc.) for pelvic organs, among other tissues. In other aspects, the present disclosure pertains to compositions that are useful for performing such procedures. In still other aspects, the present disclosure pertains to kits that are useful for performing such procedures.

Abstract: Disclosed are devices for supporting a prolapsed organ. An exemplary device comprises a ring-like body optionally having a naturally occurring substantially flat and substantially planar compact configuration, the ring-like body configured with a size suitable for insertion into a vagina and to be expanded by a support element such that in the expanded configuration an outer periphery of the ring-like body contacts a portion of the vagina and stretches at least a portion of a prolapsed vaginal wall, thereby substantially alleviating prolapse of at least one pelvic organ. The device optionally includes a support element comprising two moveably connected arms configured to support the ring in the expanded configuration.

Abstract: Devices and methods for intra-vaginal bowel control.

Abstract: An apparatus for treating urinary incontinence, comprising a node; a support section adapted for providing urethral support attached to the node; and, an anchoring section adapted for resisting movement of the apparatus attached to the node; wherein the node is no longer than 30% of the entire length of the apparatus comprising the node, support section and the anchoring section together.

Abstract: A multilevel, inflatable vaginal pessary device is soft, malleable and has a gentle gripping surface to assure retention and proper placement. The pessary device can offer options for pressure, either apically toward the cervix or anteriorly toward the bladder or posteriorly toward the rectum, via an inner silicone elastomeric (such as Silastic® by Dow Corning Corporation) balloon that can variably be filled with air from a syringe attached to a luer lock tip in the balloon. Exposure of the balloon is achieved by the physical opening potential of the fenestrated rings by cutting along guide lines in the pessary sleeve. The physician has multiple options for customizing the device to remedy the patient's prolapse.

Abstract: Articles comprising one or more calcium salts are provided. The articles can contain one or more calcium salts in an amount effective to reduce the production of TSST-1 by at least about 50% when measured by the Shake Flask Method. In certain embodiments, the one or more calcium salts can be substantially non-lethal to Staphylococcus aureus when measured by the Shake Flask Method, and/or to Lactobacillus crispatus, Lactobacillus gasseri, and/or Lactobacillus iners when measured by the Maximum Tolerated Dose Test.

Abstract: Disclosed are devices for supporting a prolapsed organ. An exemplary device comprises a ring-like body optionally having a naturally occurring substantially flat and substantially planar compact configuration, the ring-like body configured with a size suitable for insertion into a vagina and to be expanded by a support element such that in the expanded configuration an outer periphery of the ring-like body contacts a portion of the vagina and stretches at least a portion of a prolapsed vaginal wall, thereby substantially alleviating prolapse of at least one pelvic organ. The device optionally includes a support element comprising two moveably connected arms configured to support the ring in the expanded configuration.

Abstract: An applicator for urinary incontinence devices has an insertion barrel, a deployment plunger, and an adjustable insertion depth indicator. The applicators are useful to correct for a consumer's body mass index to ensure that urinary incontinence devices are placed in the appropriate position to be effective.

Abstract: This application relates to a method of covering a pessary device for relief of female incontinence with an overwrap. More particularly, the present invention relates to methods of overwrapping the pessary device.

Abstract: A device for occluding a cervix has an elongated conduit sized and shaped to extend from a proximal end outside the vagina to a distal end near the cervix. A loop sized to fit around an exocervix is provided at the distal end. The loop is sufficiently flexible to be tightened and loosened around the exocervix. The device has a rod inside the conduit. The rod has a distal end and a proximal end, and the loop is joined to the distal end of the rod. Moving the rod longitudinally relative to the conduit tightens or loosens the loop.

Abstract: Heat and/or mechanical treatments on a post-molded article to create designs or textures that extend minimally above or below a surface of the article are described.

Abstract: Kits for treating pelvic conditions such as levator avulsion, by placing an implant between an anterior incision and a posterior incision to support the levator tissue are described. A kit comprises an implant (70) comprising a support portion and two end portions extending from the support portion, two insertion tools comprising a needle comprising a helical curve and one insertion tool (54) comprising a needle (58) comprising a two-dimensional curve.

Abstract: The present disclosure suggests an apparatus for determining at least one parameter in the vaginal channel of a user. The apparatus comprises a flexible pessary and a measurement unit comprising at least one sensor for measuring the at least one vaginal parameter. The measurement unit is reversibly mountable to the flexible pessary.

Abstract: Sealing device for sealing externally debouching, natural or artificial body canals of animals or human beings, the device enabling liquid tight sealing against the inner wall of the bowel system of the animal or human being, the device further being made from a resilient material. The device is soft and resilient and may thus not trigger the analreflex, but is still able to provide a fluid-tight seal.

Abstract: Medical devices and related methods are disclosed for delivering an implant into the body of a patient. The devices include a damping assembly having an internal chamber with a varying inner diameter, and a piston slideably disposed therein. The piston is operably connected with a catheter portion such that movement of the piston is associated with concurrent movement of the catheter for implant delivery. The varying inner diameter of the damping assembly results in a decrease in damping force during implant delivery, thus providing a substantially constant velocity of implant delivery.

Abstract: Systems and related methods for measuring pelvic organ prolapse are disclosed. A plurality of positioning devices, such as RFID tags, ultrasound reflectors or magnetic field sensors, which may be active or passive, and which are preferably disposable, are set at predetermined positions within the patient and their relative positions recorded with one or more corresponding external receiving devices fixed to the patient while the patient is in a relaxed state. The patient is then instructed to perform an action (such as a valsalva maneuver) that causes the positioning devices to move and their movement relative to their initial recorded positions is measured.