Abstract: The invention relates to a pH sensor for use in a catheter drainage system. The invention also relates to a catheter, drainage bag or connection unit comprising the pH sensor of the present invention, methods of using the pH sensor and methods of making the pH sensor.

Abstract: A high performance flatus gas filter assembly, and a body waste collection pouch with which it may be used, along with a method for making such an assembly, are disclosed. The assembly includes a filter pad having first and second layers of deodorizing filter media with an imperforate gas and odor barrier layer sandwiched therebetween for blocking the direct flow of gases between the opposing inner faces of the filter layers. An envelope of liquid and gas impermeable material defines a chamber for enclosing the pad. The envelope has walls with first and second openings communicating with central portions of the first and second filter layers, and defines a peripheral space about the pad to permit the outward flow of flatus gases from the peripheral edge surface of one of the filter layers inwardly into the peripheral edge surface of the other of the filter layers.

Abstract: A sanitary protection device intended to be placed in the user's vagina (7). Distinguishing features of the sanitary protection device are that it includes a shell-like basic element (1), that the basic element (1) has in its height direction (H) a shape which narrows both upwards and downwards from an intermediate portion, and that the basic element (1) is provided with apertures (5) along part of its external surface.

Abstract: There is provided a tampon pledget that includes one or more enhanced features that result in the pledget exhibiting increased bypass leakage prevention. These enhanced features may include, but are not limited to, geometry, absorption, and any combinations thereof. There is also provided one or more methods for constructing a tampon pledget having increased bypass leakage protection.

Abstract: A menstrual cup device and a method of us thereof includes a menstrual cup made of expandable material so as to be compressed, the menstrual cup having resilience for restoring to its original shape after being compressed, the menstrual cup comprising a pulling stem at a lower end thereof, a circular lip at an open upper end thereof, and a circular groove below the circular lip; and a collection bag having a resilient restraining ring at an open upper end thereof; thereby, the resilient restraining ring being expanded to be constricted in the circular groove of the menstrual cup, the circular lip being adapted to prevent the resilient restraining ring from disengagement, the menstrual cup with the collection bag being compressed and inserted into the vagina for collecting menstrual blood, the collection bag being disposable and replaceable.

Abstract: A device and method for collection of a urine sample is disclosed which comprises a channel, an opening in the channel, and a collector associated with the opening. The channel is formed so that urine can flow through it from a first end to a second end thereof. The opening is provided in the channel at a point between the first and the second ends thereof. The collector is associated with the opening in the channel to be able to receive urine therein. In one embodiment, a member can cover the opening to permit urine to pass through it after contact with urine. Specifically, the member may dissolve or otherwise permit urine to pass through the opening after a period of time to test a urine sample which is not from the initial flow of urine to avoid bacteria contamination.

Abstract: A vaginal drug delivery system includes a device formed of porous material that holds a flowable therapeutic formulation. The device, preferably in a soft, prewetted state, is inserted into the vagina to reside typically at or near the cervix where it continuously releases the flowable therapeutic formulation through its outer surface which is in contact with the vaginal surfaces. In operation, the flowable therapeutic formulation migrates via capillary forces from a reservoir that is centrally located in the device and through a covering that envelopes the reservoir.

Abstract: A female condom has a pouch with an open end, a closed end, and a tubular body extending longitudinally therebetween. The female condom also includes an anchor attached to and outside of the closed end of the pouch.

Abstract: A female condom and an improved method for manufacturing a female condom is disclosed. The invention provides a device that is effective in both acting as a contraceptive and inhibiting the transmission of disease during coitus. The invention employs synthetic latex in an efficient and cost effect manufacturing method that results in an improved product.

Abstract: A method of making a tampon applicator having four separable components includes forming a barrel having a forward end and a rearward end opposite the forward end, forming a fingergrip having a barrel end and a plunger end, where the fingergrip has an axially extending channel between the barrel end and the plunger end and the plunger end has a cross-sectional area that is less than a cross-sectional area of the barrel end, forming an insertion tip having a first end and a second end, forming a plunger having a forward end, connecting the barrel end of the fingergrip with the rearward end of the barrel, where the barrel end of the fingergrip and the rearward end of the barrel create a continuous surface flush with the barrel when connected, connecting the second end of the insertion tip to the forward end of the barrel, and inserting the forward end of the plunger into the channel of the fingergrip.

Abstract: An automatic urine collection apparatus includes a collection container for accumulating urine transferred from a urine receiver through a tube and a main body for supporting the collection container, wherein the main body includes a suction pump for sucking the urine received by the urine receiver and carrying the urine to the collection container, a mass sensor for measuring the urine accumulated in the collection container, a control board for calculating a volume of the urine based on the measured mass of the urine, and an indicator for indicating the calculated volume of the urine.

Abstract: An extra-labia urine voiding apparatus including a container sized and shaped to externally cover a vulval region of a female anatomy. The container has an open side and defines a reservoir that is adapted for receiving urine. The container also includes a surface disposed at a top of the container adapted to face and generally surround a periphery of the vulval region. The voiding apparatus also includes a conduit in fluid communication with the reservoir of the container and adapted for draining urine from the reservoir.

Abstract: A perianal support device is provided that is configured to inhibit the formation and/or progression of tissue damage in the perianal region of the body. A method is provided to apply the perianal support device to patients during childbirth to inhibit the formation and/or progression of tissue damage in the perianal region of the body.

Abstract: An intravaginal device has a fluid storage element having a longitudinal axis and is in fluid communication with at least one fluid transport element. The at least one fluid transport element has a first plate having an outwardly oriented surface and an inwardly oriented surface and a second plate coupled to the first plate. The second plate has a first surface disposed and maintained in facing relationship with the inwardly oriented surface of the first plate and an opposite surface. The second plate is capable of separating from the first plate sufficiently to provide inter-plate capillary action. The at least one fluid transport element is bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element.

Abstract: An ostomy system for receiving bodily waste having a gas impermeable outer bag and a water impermeable inner bag enclosed within the outer bag, as well as a coupling system for attaching the bag to the body of a patient and for securing the outer bag in relation to the inner bag. The coupling system defines an orifice to enable bodily waste to be received by the inner bag and includes a barrier for preventing liquids and solid particles from passing from the inner bag to the outer bag, at least part of the barrier being permeable to flatus gasses. The barrier may be in the form of a foam. The outer bag has an outlet with a flatus filter for releasing flatus gases from the outer bag. An inner bag is provided, which maintains its physical integrity, e.g. its buoyancy, upon immersion in water.

Abstract: A colostomy bag with a vent and a method for venting gas collected in the colostomy bag. A dual vent and cap assembly attached to a colostomy bag vents gas trapped in the bag either continuously or as periodically desired by a user. A method for venting gas collected in the colostomy bag provides that replacement and/or cleaning of the colostomy bag is reduced. Also, a method of using a disposable sleeve in combination with a clip may be used to hygienically clean the colostomy bag.

Abstract: The present invention relates to urination apparatus for urine sample collection for testing of urine, waste urine collection for disposal of urine resulting from urination away from toilets, and simplification of urination by women without sitting on a toilet. A urine sample collection apparatus (100B) has a tubular portion (3) having a coupling (60A) in the side thereof formed for releasably mounting an open topped urine sample collection container (70) thereto in a direction extending generally away from the axis of said tubular portion. The apparatus also has a urine receiving receptor (1B) with a surface portion (4B) extending from a rim (5B), bounding an inlet surface which is symmetrical about the axis of said tubular portion, to an aperture (2B) from which said tubular portion extends in a direction generally away from said inlet surface.

Abstract: A vaginal discharge collection device is formed of an elastomeric rim and a flexible film reservoir lined with a non-toxic absorptive material. The rim may have a generally rectangular cross section and forms a collection space for collecting vaginal discharge. The rim is sufficiently resilient to provide an outward resilient force suitable to maintain the device in position within a user's vaginal canal during use. The rim and the reservoir are arranged such that compressing diametrically opposed portions to facilitate insertion of the device. The reservoir may be collapsible so as to be substantially enclosed within the rim when the device is being used. The device is constructed to be easy to use, affordable, internally comfortable, and most of all efficient.

Abstract: A urinary incontinence device includes a working portion having an insertion equivalent diameter ranging from about 10 to about 25 mm and a use equivalent diameter ranging from about 25 to about 35 mm under an expansion pressure of about 20 to about 150 cm H2O.

Abstract: Digital tampons are disclosed which are capable of radially expanding into a non circular cross-sectional shape upon exposure to a wet environment, typically in use condition, so as to reduce bypass leakage. The inventions also relates to tampon blanks and a process of producing the tampons.

Abstract: An intra-vaginal self-administered cell collecting device and method includes inserting a tampon-like telescoping tube intra-vaginally. The tube includes an expandable preformed absorbent member having a textured cover. The absorbent member also includes a retrieval member extending therefrom. The tube is manipulated to expel the absorbent member intra-vaginally. The tube is removed and the absorbent member is retained intra-vaginally for a period of time. The absorbent member is retained from expanding from its preform when exposed to vaginal fluids by means of a cover on the absorbent material. The cover also captures soughed-off cells in the vaginal fluids. The absorbent material is retrieved manually by the retrieval member.

Abstract: A vaginal discharge collection device is formed of an elastomeric rim and a flexible film reservoir. The rim may have a generally rectangular cross section and forms a collection space for collecting vaginal discharge. The reservoir may be collapsible so as to be substantially enclosed within the rim when the device is being used. Advantageously, the rim and the reservoir are arranged such that compressing diametrically opposed portions of the rim toward each other causes a leading portion of the rim to dip downwardly to facilitate insertion of the device. The device is ergonomically constructed so as to be convenient to use, comfortable to wear internally, and reliable. A system for reliably, comfortably and conveniently introducing agents, including drugs and other substances, into the vaginal canal is also disclosed.

Abstract: An intra-vaginal self-administered cell collecting device and method includes inserting a tampon-like telescoping tube intra-vaginally. The tube includes an expandable preformed absorbent member having a textured cover. The absorbent member also includes a retrieval member extending therefrom. The tube is manipulated to expel the absorbent member intra-vaginally. The tube is removed and the absorbent member is retained intra-vaginally for a period of time. The absorbent member is retained from expanding from its preform when exposed to vaginal fluids by means of a cover on the absorbent material. The cover also captures soughed-off cells in the vaginal fluids. The absorbent material is retrieved manually by the retrieval member.

Abstract: An intravaginal inflatable member impermeable to fluids capable when inflated of providing sealable closure of the vaginal canal for the prevention of exit of menstrual blood from the vaginal orifice. The inflatable member can be connected to an absorbent member or can be a stand alone device. Inflation of the inflatable member can be activated manually by the user or via an intravaginal applicator which has the dual function of inserting and delivering the device into the vagina and that of actuating the source of inflation to inflate the inflatable member.

Abstract: A catamenial device for blood leakage prevention composed of an inflatable-expandable member and an absorbent intravaginal member such as a tampon. The inflatable-expandable member houses a resiliently expandable inflation member generally made of open cell foam. Prior insertion into a vaginal canal, the inflation member is in a contracted state. Upon placement to proper vaginal location, the inflation member expands by resiliency drawing air from a space inside the balloon or a reservoir of the balloon where the air has been displaced and housed when the air has been squeezed out from the open cell foam when the inflation member has been compressed prior to insertion. Inflation-expansion of the inflatable member can be activated manually by the user or via an intravaginal applicator which has the dual function of inserting and delivering the device into the vagina and that of actuating the inflation-expansion of the inflatable member.

Abstract: An intra-vaginal self-administered cell collecting device and method includes inserting a tampon-like telescoping tube intra-vaginally. The tube includes an expandable preformed absorbent member having a textured cover. The absorbent member also includes a retrieval member extending therefrom. The tube is manipulated to expel the absorbent member intra-vaginally. The tube is removed and the absorbent member is retained intra-vaginally for a period of time. The absorbent member is retained from expanding from its preform when exposed to vaginal fluids by means of a cover on the absorbent material. The cover also captures soughed-off cells in the vaginal fluids. The absorbent material is retrieved manually by the retrieval member.

Abstract: An intravaginal inflatable member impermeable to fluids capable when inflated of providing sealable closure of the vaginal canal for the prevention of exit of menstrual blood from the vaginal orifice. The inflatable member can be connected to an absorbent member or can be a stand alone device. Inflation of the inflatable member can be activated manually by the user or via an intravaginal applicator which has the dual function of inserting and delivering the device into the vagina and that of actuating the source of inflation to inflate the inflatable member.

Abstract: An intravaginal inflatable member impermeable to fluids adapted to collect upon inflation, menstrual blood and also capable of [provide] providing sealable closure of the vaginal canal for the prevention of vaginal exit of menstrual blood. By being inflatable, the device is easily inserted and removed when deflated and is also capable of sealing off the blood collected avoiding the spillage of blood upon extraction and disposal. The inflation of the device can be conveniently initiated prior to insertion into vagina and completed with the device fully inserted or can be initiated and completed with the device already inserted into the vagina. Inflation of the device can be achieved without the use of an external pneumatic source, but with a self-inflating apparatus within the device. The cup shaped member can be used as a standing alone device or in combination with a vaginal tampon for the prevention of blood leakage.

Abstract: A vaginal device such as a cervical cap diaphragm vaginal ring or other intra-vaginal device designed for delivery of biologically active materials has a first member and a second member which are selectively attached to each other, at least one of the members comprising a releasable biologically active material.

Abstract: An intravaginal inflatable member impermeable to fluids capable when inflated of providing sealable closure of the vaginal canal for the prevention of exit of menstrual blood from the vaginal orifice. The inflatable member can be connected to an absorbent member or can be a stand alone device. Inflation of the inflatable member can be activated manually by the user or via an intravaginal applicator which has the dual function of inserting and delivering the device into the vagina and that of actuating the source of inflation to inflate the inflatable member.

Abstract: An intravaginal device having an overwrap containing an enclosed material, and a withdrawal string passing through a portion of the overwrap formed into a loop, the withdrawal string enabling a user to remove the intravaginal device after use.

Abstract: A female external catheter device collects and then channels urine away from the human body to a collection drain. The device minimizes urinary track infections, nosocomial infections and reduces a patient's risk of infection complications. The device also reduces usage of indwelling urinary catheters. It is characterized by a ladle-like geometry in which the spoon thereof is an intra-labial collection cup and the handle is a hollow neck and nob that is secured within the vagina. Apertures with the nob enable venting of vaginal fluids thru a fluid egress channel.

Abstract: A female specimen gathering device is disclosed which can be self administered by women to collect specimens from the vaginal cavity. In particular, the device includes an insertion conduit structured to be at least partially introduced into the vaginal cavity of the female and a collection element housed within the insertion conduit to ultimately collect the specimen. A handle coupled with the collection element is provided to protrude the collection element from the insertion conduit and cause it to engage the sample collection location in order to actively collect a specimen therefrom. A fixative container is further provided and is structured to receive the collection element with the collected specimen, a multi-compatible fixative fluid being maintained in the fixative container in order to effectively preserve both fluid and solid types of specimen for a variety of different test procedures that permit testing for a variety of different conditions.

Abstract: An absorbent interlabial device worn by female wearers for catamenial purposes, incontinence protection, or both, is disclosed. The absorbent interlabial device has at least one body-contacting surface which comprises a substance that contacts the wearer's body for assisting the interlabial device in staying in place in the desired position in the interlabial space. The substance can be either adhesive or non-adhesive. In embodiments in which the substance is non-adhesive, it may have no initial tack so that it will not stick to the wrong portions of the wearer's body when the device is placed between the labia. Non-adhesive substances include moisture-activated substances which become viscous and develop a tack when contacted by relatively small amounts of moisture.

Abstract: The present invention relates to an absorbent article designed and configured to fit between the labia. The article employs a plurality of stacked, flexible elements and provides improved fit and article retention, improved collection of bodily fluids and solids typically left unabsorbed by conventional interlabial products, ability to deliver various additives such as medicaments to the tissue surrounding the labia, and an adjustable placement depth to meet consumers varying physical and psychological needs.

Abstract: A device is provided for reliably, comfortably and conveniently introducing agents, including drugs and other substances, into the vaginal canal. A discharge collection device is also disclosed. The disclosed devices may be formed of an elastomeric rim and a flexible film. The rim may have a non-circular cross section. The film may be collapsible into a low profile insertion configuration. The devices may be disposable, and may be constructed so as to be convenient to use, comfortable to wear internally, and reliable. Preferably, the devices are formed of thermoplastic material that softens in response to body temperature to provide improved comfort and handling.

Abstract: An apparatus for manufacturing a device having a first elastomeric portion and a second elastomeric portion, the second elastomeric portion being formed into a non-planar shape, i.e., a vaginal discharge collection device that is formed of an elastomeric rim and a flexible film reservoir. The apparatus includes a loading station for loading a rim into a carrier plate, a heat seal station for laying and forming a film over the rim, a preheating station for preheating the rim and film, a forming station for drawing the film into a chamber by creating a vacuum to form the collector, and an unloading station for removing the collector from the carrier plate.

Abstract: A collection device for human bodily fluids includes an expandable, liquid permeable and insoluble pouch containing a proper volume of hydrophilic material. This hydrophilic material allows quick absorption of such fluids and turns into gelled material. The gelled material is then trapped inside the pouch preventing possible spill and back flow. The hydrophilic material with a proper volume only allows expansion up to the predetermined size of the pouch without the pouch breaking up into fragments. This pouch may be made of different shapes and materials in order to fit in different types of human bodily fluid collection devices and reduce possible leakage and back flow. The hydrophilic material can be a polymer and may have antibacterial properties to reduce bacteria growth. A one-way valve, snap-fit seal, or screw-on cap may be added for further enhanced prevention of leakage and back flow. The versatility of this pouch helps speeding up manufacturing processes and reducing overall production costs.

Abstract: A human female cervical specimen gathering device is disclosed which can be self administered by women. The device consists of a cardboard tube that houses a retractable sponge, The handle is adapted to allow it to serve as a screw-cap lid, once the device is inserted into a conical tube containing fixative or preservative. After transport to the lab the tube call easily be agitated to liberate cells, centrifuged, and prepared as a thin smear for cytology or DNA probes.

Abstract: A urinary incontinence appliance constructed according to the invention includes hydrophilic absorbing media encased in a water-impermeable sheath having a closed end that is inserted into the vagina of the user and an open end external to the vagina that is form fit to cover the urethra of the user. The external open end portion acts to funnel any urine that may escape from the urethra into the interior of the sheath where it is captured and wicked by the absorbent media within the vagina.

Abstract: A cervical collection device (20) for collecting uterine and cervical secretions for medical diagnostic purposes. The cervical collection device (20) is placed over the cervical opening (14). Collection device (20) includes an outer elastomeric receptacle (22) of a hemispherical shape having a collection capsule or pad (26) fitting thereon. Collection pad (26) includes an inner layer or core (28) of absorbent material and an outer water-resistant cover (32). Collection member (26) has an outer convex surface conforming to the inner surface of the elastomeric receptacle (22). Receptacle (22) has an outer rim (24) arranged for fitting over the cervical opening (14) for removable securement of collection device (20) to a user. Inner layer (28) may be formed of various materials and impregnated with selected substances.

Abstract: Absorbent devices, and more particularly absorbent devices that are worn interlabially by female wearers for catamenial purposes, incontinence protection, or both, are disclosed. The absorbent interlabial device of the present invention comprises a main absorbent portion with an upper portion, a lower portion opposed to the upper portion, and two ends. The upper portion faces toward the vestibule of the wearer during insertion of the device into the wearer's interlabial space and during use. The ends of the absorbent device are preferably taped so that the lower portion of the interlabial device is longer than the upper portion. The ends are also provided with at least one curvilinear segment, with the ends preferably having a sinusoidal or S-shape. The absorbent interlabial device preferably also has an arcuate pattern of discrete autogenous bonds.

Abstract: Absorbent devices, and more particularly absorbent devices that are worn interlabially by female wearers for catamenial purposes, incontinence protection, or both, are disclosed. The absorbent interlabial device of the present invention comprises a main absorbent portion with an upper portion, a lower portion opposed to the upper portion, and two ends. The upper portion faces toward the vestibule of the wearer during insertion of the device into the wearer's interlabial space and during use. The ends of the absorbent device are preferably taped so that the lower portion of the interlabial device is longer than the upper portion. The ends are also provided with at least one curvilinear segment, with the ends preferably having a sinusoidal or S-shape. The absorbent interlabial device preferably also has an arcuate pattern of discrete autogenous bonds.

Abstract: A disposable device for transfer of an active liquid into an intracorporeal cavity, having a central element able to contact the mucous membrane of an intracorporeal cavity; an absorbent peripheral element arranged around the central element that absorbs liquid; a temporary protective covering, that is sealed with respect to liquids, that prevents fluid communication between the peripheral element and the central element; an active liquid contained in the central element or the peripheral element; and a means for recovering the active liquid, which has circulated in the intracorporeal cavity, that is contained in the peripheral element or the central element, respectively.

Abstract: The present invention provides a intravaginal collection device for the collection of vaginal discharge. The present collection device comprises a first layer that allows the passage of fluid therethrough but substantially prevents the passage of tissue and blood cells therethrough. The perimeter of the first layer is attached to a resilient rim. The rim is sufficiently resilient to provide an outward resilient force suitable to maintain the device in position within a user's vaginal canal during use. The device also comprises a second layer attached at its perimeter to the resilient rim. The second layer is suitable to substantially prevent the passage of fluid therethrough. The device further comprises a fluid retention layer positioned between the first layer and the second layer. The fluid retention layer is suitable for retaining fluid passed through the first layer.

Abstract: A reusable tampon includes an interior cavity which can be filled with absorbent material. The absorbent material can be removed and new absorbent material inserted in its place through an opening in an upper portion of the tampon. The tampon has a body which is hollow and formed of flexible, human tissue-friendly material. The lower part of the body is closed and has a semi-circular shape. Inflow apertures in the body of the tampon are inclined inwardly and toward the semi-circular lower portion of the body, allowing menstrual blood to pass into the interior cavity. Axially extending inflow grooves may also be provided. The tampon may have an elliptical cross-section, and a plurality of small balls of highly aborbent material may be disposed in the interior cavity.

Abstract: A disposable urine bag for females, including a bracket having an open bearing frame at one end for fitting around the vulva and a flat handle at an opposite end for carrying by hand, a polybag fastened to the open bearing frame for collecting urine, and a packing member fitted into an endless mounting groove on the open bearing frame to hold down the polybag.

Abstract: A menstrual, flow-controlling tampon comprising a generally upright insertion tube having upper and lower ends; flow-receiving structure positioned within the tube to be bodily displaced and expelled from the upper end of the tube; the flow-receiving structure having a deployable portion configured to distend from a downward collapsed position to an upwardly deployed condition, to extend into engagement with vaginal walls associated with the cervix, and accommodation to length of vaginal barrel, following its being expelled from the tube; and removal structure associated with the receiving structure to effect withdrawal thereof away from the cervix, whereby upper extent of the deployable portion of the flow-receiving structure gathers to retain flow in the flow-receiving structure during withdrawal.

Abstract: A flow-controlling tampon, comprising, in combination a generally upright insertion tube having upper and lower ends, and a plunger within said tube and manipulable proximate the tube lower end; flow receiving structure positioned within the tube to be bodily displaced and to protrude from the upper end of the tube in response to the manipulation of the plunger, the flow receiving structure having an upper end portion configured to expand to extend about the cervix in response to upward bodily displacement of the flow receiving structure effected by the plunger; and removal structure associated with the upper end portion of the receiving structure to effect contraction thereof when the receiving structure is withdrawn away from the cervix. The flow receiving structure typically includes flow absorbent material contained within a thin moisture resistant sheath having an expansible upper end that is contracted by pulling on strand structure.

Abstract: A malleable vaginal speculum is manually shaped to dilate the inner contour of a vagina sufficiently to allow manipulation of endoscopic surgical instruments within the vagina. The malleable vaginal speculum may optionally be coupled a funnel, apron and splash shield to function as a fluid collector for use during endoscopic surgery. A portion of the splash shield is placed under the patient while the remainder extends to a perforated portion of the funnel wall. Fluid draining into the funnel through its mouth and through the perforated wall is collected in a container, where its volume is measured. By measuring the volume of irrigation fluid dispensed during the surgery and subtracting the measured fluid volume collected, an estimate of the amount of irrigation fluid absorbed by the patient during the surgery is obtained.