Abstract: The systems, devices and methods provide customizable and adjustable support to anatomical tissue or organs, such as pelvic, vaginal, uterine, cervical, bladder, rectal, among others, or any combination thereof. The anatomical support device may include a support member having a periphery that surrounds an opening. The support member may be configured to releasably and adjustably expand between one or more expanding states from a resting state and contract to the resting state. The support member may include a first portion and a second portion disposed along the periphery. Each portion may include a passage cross-sectional area and a wall thickness. The first wall thickness and/or the first passage cross-sectional area of the first portion may be different from the second wall thickness and/or the second passage cross-sectional area of the second portion.

Abstract: A system for in-vivo monitoring of pressure of a body fluid. The system comprises a delivery component and an elongate sensor delivery member shaped so as to pass through the delivery component when it has been inserted in to a patient. A first pressure sensor is positioned at a distal end of the delivery member.

Abstract: Embodiments disclose uterine manipulators, dye delivery systems and fornix delineators that address several issues, such as minimizing surgical error, minimizing loss of parts inside a patients, enabling easy manipulation of a patient's anatomy, securing and removing the device into and from the patient atraumatically, preventing loss of pnuemoperitoneum, and securing the device fastener and components efficiently and atraumatically. An embodiment includes a uterine manipulator having a fornix delineator, uterine shaft, outer tube, fastener, handle, inlet, tip, ring and connecting string, and/or occluder.

Abstract: Everting balloon systems and methods for using the same are disclosed herein. The systems can be configured to access and dilate body lumen and cavities. For example, the systems can be used to dilate the cervix and access the uterine cavity. The systems can also be used to occlude the cervix. The systems can also be used to occlude the urethra.

Abstract: Everting balloon systems and methods for using the same are disclosed herein. The systems can be configured to access and dilate body lumen and cavities. For example, the systems can be used to dilate the cervix and access the uterine cavity. The systems can also be used to occlude the cervix. The systems can also be used to occlude the urethra.

Abstract: A method and device for the diagnosis and treatment of pelvic floor prolapse is provided. The diagnosis and treatment may involve the use of a multiple sensor-enabled device for vaginal insertion capable of providing real-time data regarding the patient's physiology, the position and movement of the urethra, and the muscular strength of the patient's vagina and pelvic floor. The methods and devices of the invention may also be useful to addressing other medical issues, including urinary incontinence, sexual health, and fecal incontinence, as well as facilitate patient home wellness activities.

Abstract: A system and method for stabilizing an incontinent cervix during pregnancy are described. A system may include a nesting portion designed to surround the cervix without applying pressure to the cervix, while supporting the uterus in opposition to the weight of the developing fetus to prevent untimely effacement and dilatation of the cervix, thereby reducing the risk of premature birth and its consequence.

Abstract: A patch for repairing an intra-abdominal defect is disclosed in one embodiment of the present invention as including a mesh layer providing a grid of material perforated by apertures through the mesh. This mesh is used to reinforce an area around an intra-abdominal defect. A containment layer is secured proximate an edge of the mesh layer. A filler is distributed across the apertures of the mesh to contain a fluid from passing through the mesh. The mesh layer, containment layer, and filler are connected to form a chamber to selectively expand upon receipt of a quantity of fluid between the containment layer and the filler.

Abstract: Everting balloon systems and methods for using the same are disclosed herein. The systems can be configured to access and dilate body lumen and cavities. For example, the systems can be used to dilate the cervix and access the uterine cavity. The systems can also be used to occlude the cervix. The systems can also be used to occlude the urethra.

Abstract: A device and method for measuring the structural integrity and structural health of the female pelvic floor, or other lumenal organ, is disclosed. Said device comprises an insertable probe with a pressure chamber capable of distending the walls of said lumenal organ. The invention also comprises means for positioning the pressure chamber and adjusting its location along the lumen. Said device also comprises means for changing and recording the volume and pressure of a balloon which is part of the pressure chamber, and means for determining and recording the location of the walls of the balloon. Said device also comprises a means for integrating information obtained to determine important biomechanical information, such as stress-strain curves, which a medical clinician can use for diagnostic purposes. Said method comprises the insertion of said probe, the expansion and contraction of the pressure chamber under desired condition, and means for analyzing obtained data for increased usefulness to the clinician.

Abstract: A patch for repairing an intra-abdominal defect is disclosed in one embodiment of the present invention as including a mesh layer providing a grid of material perforated by apertures through the mesh. This mesh is used to reinforce an area around an intra-abdominal defect. A containment layer is secured proximate an edge of the mesh layer. A filler is distributed across the apertures of the mesh to contain a fluid from passing through the mesh. The mesh layer, containment layer, and filler are connected to form a chamber to selectively expand upon receipt of a quantity of fluid between the containment layer and the filler.

Abstract: A system for treating pelvic organ prolapse includes a hollow shell, a net, and an anchor strap. The hollow shell has an apex, with an exterior surface of the apex shaped to conform to an interior apical portion of a vagina, and the apex includes a hole. The net is associated with the apex of the hollow shell such that the net is insertable inside the vagina and conformable with the interior apical portion of the vagina. The anchor strap has a length that configures a proximal portion of the anchor strap to be attachable to the hole in the apex of the hollow shell and a distal portion of the anchor strap to be attachable to a sacrum of a patient.

Abstract: An apparatus for amelioration of incontinence in a female subject. The apparatus comprises a stiffenable ring adapted for intra-vaginal insertion and a stabilizing extension, projecting axially from the stiffenable ring, the stabilizing extension having a size and position configured to stabilize the stiffenable ring within the vagina.

Abstract: A method for stemming or stopping bleeding of a hemorrhagic uterus. A pair of rigid shells in which pair of inflatable bladders is nested is placed in mirrored spaced opposition to one another in front of and behind the uterus and the broad ligament supporting the uterus. The rigid shells include a proximal base and a distal portion and have a releasable interlock comprising at least one latch only on the proximal base of one shell and at least one latch catch only in the proximal base of the other shell. The proximal base of each shell provides a platform to cantilever the distal portions when the shells are interlocked. After the placed shells are releaseably interlocked, the bladders are inflated to compress the uterus anteriorly and posteriorly to stem or stop hemorrhage.

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: 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: An endocervical seal has a sleeve with a passageway for receiving an intrauterine interventional or diagnostic tool. The sleeve has a coaxially disposed outer balloon with a distal portion configured to inflate in a cervical os and a proximal portion configured to inflate in a cervical canal.

Abstract: An intravaginal support apparatus. The intravaginal support apparatus comprises a pessary ring having a substantially annular configuration and a narrowed configuration, a locking mechanism which retains and switches between the annular configuration and the narrowed configuration, and one or more expandable elements having expanded and unexpanded configurations, attached to one or more of the locking mechanism and the pessary ring. The pessary ring laterally expands from the narrowed configuration to the annular configuration; the expandable element expands outwardly of the pessary ring, from the unexpanded configuration to the expanded configuration.

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: In order to prevent tainting of a cougher's hand with germs, the product from a cough is carried in contact with a germicide inside a hollow article, and is vented out of the hollow article, in directions away from the user's face and hand holding the article. More specifically, the cough catcher has a hollow region for accepting the product from a cough therein. This hollow region has a filter element containing a germicide mounted therein, and a series of channels formed between the filter element and a bottom surface of the hollow region. The channels communicate with vent ports around a rim portion of the cough catcher. The vent ports are oriented away from both the mouth opening and the outside surface of the cough catcher for conveying the product from a cough away from both the face and the hand of a user.

Abstract: Vaginal splints and methods for their use for treating various pelvic floor conditions are provided. One embodiment of the vaginal splint includes a base portion having a configuration defined by first and second sides, a first connecting portion at a proximal side of the base portion and extending between a first end of each of the first and second sides, and a second connecting portion at a distal side of the base portion and extending between a second end of each of the first and second sides. The splint further includes an adjustable portion coupled to the base portion and positioned substantially adjacent to and distal of the second connecting portion of the base portion. The adjustable portion is removable by a user to thereby change the size of the splint.

Abstract: A method for repairing a vaginal wall (35) which has been damaged by one or more prolapsed pelvic organs said method including:(a) mobilising the vaginal epithelium off the underlying fascia of at least a portion of the damaged vaginal wall; (b) positioning a prosthetic material (36) over the exposed fascia; (c) re-fixing the vaginal epithelium over the prosthetic material (36) and the fascia; and thereafter (d) locating an intra-vaginal splint into the vagina.

Abstract: Vaginal splint assemblies and methods for their use for treating various pelvic floor conditions are provided. One embodiment of a vaginal splint assembly includes a base portion having a connecting portion and first and second sides extending outwardly from first and seconds ends of the connecting portion to first and second free ends respectively. It further includes a plurality of apical sections each of a different size and each having a connecting portion and first and second sides extending outwardly from first and second ends of the connecting portion to first and second free ends respectively, and at least first and second coupling elements. The first coupling element is capable of securing the first free end of the base portion to the first free end of any one of the plurality of apical sections, and the second coupling element is capable of securing the second free end of the base portion to the second free end of the one apical section.

Abstract: Vaginal splints and methods for their use for treating various pelvic floor conditions are provided. One embodiment of the vaginal splint includes a base portion having a configuration defined by first and second sides, a first connecting portion at a proximal side of the base portion and extending between a first end of each of the first and second sides, and a second connecting portion at a distal side of the base portion and extending between a second end of each of the first and second sides. The splint further includes an adjustable portion coupled to the base portion and positioned substantially adjacent to and distal of the second connecting portion of the base portion. The adjustable portion is removable by a user to thereby change the size of the splint.

Abstract: An intravaginal uterine artery occlusion device is used for treating uterine disorders such as fibroids, dysfunctional uterine bleeding, postpartum hemorrhage and the like. A occlusion device has a cervical receptacle with an open distal end for receiving the patients uterine cervix, an elongated shaft having a distal end secured to the closed proximal end of the cervical receptacle, and an inner lumen extending to the distal end of the shaft. The patient's uterine cervix is held within the interior of the receptacle by the application of a vacuum to the interior of the receptacle through the inner lumen of the shaft while the leading edge(s) of the cervical receptacle press against the patient's vaginal fornix to occlude the uterine artery. A blood flow sensor may be provided on the leading edge of the receptacle to aid in locating a uterine artery and to monitor blood flow through the uterine artery.

Abstract: An adjustable vaginal pessary (2) comprising a body (4) with an outer periphery, and an inner periphery defining an aperture (10). The pessary further comprises at least one adjustable portion (12,13) located on the body between said inner and out peripheries. The adjustable portion is bounded by two ends (12a, 12b, 13a, 13b) of the body interfacing therewith. T portion is adapted to vary the distance between the two ends in the direction along the body's perimeter, thereby adjusting the length of the peripheries.

Abstract: A catamenial device for blood leakage prevention composed of an inflatable member and an absorbent intravaginal member such as a tampon. The inflatable member houses a resiliently expandable inflation member generally made of open cell foam, and has an opening for airflow communication between the interior of the inflatable member and the outside environment. During insertion into a vaginal canal, the inflation member is inserted in a contracted state. Upon placement to proper vaginal location, the inflation member expands by resiliency drawing air from the ouside environment into the inflatable member via the opening in the inflatable member. 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 inflation of the inflatable member.

Abstract: A device for regulating and controlling urinary incontinence, comprising a fluid pump, a rigid chamber interconnected to the pump having an outlet for fluid flow, and extension member connected to said outlet, the extension member is of a pliable material and cylindrical in shape and adapted for insertion into a woman's vagina, to enable a woman's pelvic muscles to be exercised and toned.

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: The pessary 22, which will alleviate the common female problems of stress incontinence and prolapse, includes an annular hollow body 24 and an air tube 26. The hollow body is ring shaped and is made deflatable. While the body 24 is being inserted into the vagina it is evacuated which diminishes its size and thereby reduces the discomfort associated with insertion. Once in place in the vagina, air is given free access to the hollow device 24 whereby elasticity of the device causes it to expand to its normal shape. When the device 24 is to be removed from the vagina the tube 26, which is preferable coiled and stowed at the center of the ring shaped device 24, is extracted and connected to the hollow needle of a syringe. When the syringe sucks out air, the hollow body 24 diminished in size, which reduces the discomfort associated with its removal.

Abstract: A pessary insertion apparatus providing a rigid, elongated body having an crescentic shape. The body defines a bottom portion and a pair of opposing side wall portions. The side wall portions extending from the bottom portion a distance approximately equal to or greater than the height of the folded pessary. The body sized and adapted to hold the pessary therein. The crescentic shape extending the full length of the body so that, when in the vaginal cavity, the body holds the vaginal cavity open and defines a passageway through which the user may reach the back end of the pessary to force the pessary from the body and into position. Holes in the bottom portion of the body enhance gripping of the pessary insertion apparatus.

Abstract: The present invention is directed to an intraoral device that can be used for absorbing tar and nicotine or dispensing various substances over a period of time. The device includes a flexible pad which is disposed within the mouth of a wearer. A plurality of tar and nicotine absorbent particles are embedded in the flexible pad. Often, a retainer portion is attached to the flexible pad to engage the teeth of the wearer for holding the flexible pad in a desired position within the wearer's mouth. Additionally, the flexible pad may also be impregnated with a breath freshener or medications having enteric coatings.

Abstract: A pessary device, comprising a first inflatable chamber adapted to fit in the vestibule of the vaginal cavity of a human when inflated, wherein the chamber compresses the urethra of the human when inflated; an anchor member adapted to snugly fit in the vaginal cavity, the anchor member being connected to the inflatable chamber on the posterior side of the chamber when the pessary is in its normal operating position; and an inflation tube having a first end fluidly connected to the inflatable chamber and a second end connected to an inflation valve located external to the vagina when the pessary device is in its normal operating position that permits inflation and deflation of the inflatable chamber without disturbing the fit of the anchor member.

Abstract: A vaginal pessary (10 or 34) used to control urinary incontinence or a prolapse, which pessary has a hollow annular body (12 or 36) and an elongated fluid conveying flexible elongated tube (16) which may be stored between the upper and lower surfaces of the annular body when the pessary has been properly inserted into the vagina. The annular body is provided with a diaphragm (20) attached to the inner surface (12.2 or 36.2) of the body, the diaphragm having a central aperture (22). The tube (16) has a coiled shape by making the tube from an elastic material having a memory, by having the tube carry a spring wire (18) forming into a coiled shape, or both. In the illustrated embodiments, a one way valve (24) is provided in an end portion (16.2) of the tube. The valve may be opened by inserting a hypodermic needle carried by a syringe to either cause the body (16) to assume its normal operational volume or to have its volume reduced for insertion or removal.

Abstract: A vesicovaginal apparatus for ambulatory monitoring of the detrusor pressure exerted by a bladder includes a first transducer configured and dimensioned for insertion into and retention by the bladder of a wearer during ambulatory motion for sensing the total pressure within the bladder, and a second transducer configured and dimensioned for insertion into and retention by the vagina of a wearer during ambulatory motion for sensing the pressure within the vagina. A portable recorder in operative communication with the first and second transducers records the total pressure sensed in the bladder and the pressure sensed in the vagina, with the difference indicating the detrusor pressure exerted by the bladder of the wearer.

Abstract: A cervical pressary having a central stem with a passage from end to end thereof. A distal retainer is provided at the distal end of the stem, and a proximal retainer at the other end. The retainer are flexible and distensible. They are connected to each other through the stem passage, and are inflatable by fluid injected into them. A leaflet-type fill valve passes through the wall of the proximal retainer. Th fill valve closes when outside pressure is exerted on the leaflets. The fill valve can be physically opened by insertion of a fill tube into it.

Abstract: Pessary particularly applicable in the treatment of prolapses of internal female sex organs, which pessary is formed by a ring-shaped member constructed of such material or such materials that the ring can be deformed by hand to any given shape and the circumferential dimension of the ring can be increased or decreased to some extent by hand, after which the ring retains the ultimately given shape and circumferential dimension. Preferably the ring (1) consists of a core (4) which has the shape of a spiral of non-resilient nature and a flexible casing (5) enclosing said core (4).