Abstract: Apparatus, methods and kits which, when installed or used, occlude or partially occlude a cervical canal, the internal opening of a cervical canal (cervical os), or a uterine side wall rupture location, such as to inhibit or prevent bacterial access and retard leakage of amniotic fluid resulting from PROM. The present apparatus can include an expandable support member of a biocompatible and non-toxic material. In some examples, the support member can include a top portion having a first diameter and a bottom portion having a second diameter less than the first diameter. In some examples, the support member can include an expandable stent of a suitable length and uniform diameter to be inserted in a non-dilated cervical canal or transabdominal access route. In various examples, the apparatus further includes a fluid-resistant fabric, polymer, substance or other material placed over at least the top portion of the support member.

Abstract: Apparatus is provided for use with a subject's body, vagina, vaginal fornix, uterus, and uterine artery. A fornix-engaging structure is inserted into the vagina and engages the vaginal fornix. A rod is inserted into the subject's body via the fornix-engaging structure, such that a distal end of the rod passes through vaginal tissue at a first vaginal site until the distal end of the rod is at a first extrauterine site outside of the uterine artery, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid. A rod-guide is coupled to the fornix-engaging structure, and guides the distal end of the rod to the first extrauterine site. A uterine artery compression device is disposed on the distal end of the rod. Other embodiments are also described.

Abstract: Apparatus is provided, including a tube (22) that is configured to pass into a patient's vagina (26) and to penetrate vaginal tissue (24) until a distal tip (36) of the tube is outside of a uterine artery (28) of the patient, but in a vicinity of a portion (38) of the uterine artery that supplies a uterine fibroid (30). A balloon (40), disposed at the distal tip, is inflated to cause local squeezing of the portion of the uterine artery to an extent sufficient to occlude the uterine artery. Other embodiments are also described.

Abstract: A multi-layer inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. The outer layer and the inner layer of the balloon cuff may have different material properties that may enhance a cuff's mechanical pressure seal by reducing wrinkles or folds that may form against a patient's tracheal walls.

Abstract: A rectal balloon apparatus has a shaft with a fluid passageway extending therethrough. A balloon is affixed over an end of the shaft such that the fluid passageway communicates with an interior of the balloon. The balloon has a laterally flat surface thereon when inflated. The laterally flat surface of the balloon has a longitudinal groove formed thereon. A valve assembly is affixed to the shaft at an end opposite the balloon. The valve assembly selectively allows a fluid to pass therethrough to move the balloon from a non-inflated condition to an inflated condition. A fluid introducing means is removably attached to the valve assembly to introduce the fluid into the valve assembly.

Abstract: A vaginal insert formed from a composition that, prior to introduction to the vagina, has the physical properties of a liquid, semi-soft gel, paste, foam, or viscous material so that it can be effectively delivered to the vaginal canal. After introduction into the vagina, the composition will expand and/or solidify into a semi-solid or solid structure to substantially fill the entire “H” shaped space of the vagina and a portion of the rugal folds along the length of the vaginal canal. Upon solidifying, the composition defines an insert that, in one embodiment, is suitable for use as a tampon and, in another embodiment, is suitable for use as an incontinence device.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: A system for implanting an implant and method thereof is disclosed. In general overview, the system includes an implant, an envelope enclosing the implant, a delivery assembly and an attachment piece for attaching the envelope or implant to the delivery assembly. The envelope may include a drug coating, positioning aids, and means to ease envelope removal. In one embodiment, the delivery assembly is employed for implant and/or envelope delivery inside the patient's body. In another embodiment, the delivery assembly and an attachment piece are employed to deliver the implant or the envelope inside the patient's body.

Abstract: An apparatus for treating pelvic organ prolapse, comprising a main body adapted to provide pelvic organ support when inserted into a vagina; and, an applicator for inserting the main body into a vagina.

Abstract: A balloon tamponade catheter for controlling uterine postpartum hemorrhage has an elongated body with a balloon at a marginal distal end of the elongated body for insertion into the uterus. The balloon preferably has a pear-shaped appearance. The balloon may have a first hemisphere that is located on the catheter distal to second, smaller hemisphere. The first hemisphere has a plane of maximum diameter that is larger than the second hemisphere's plane of maximum diameter. Between the two planes of maximum diameter, the balloon comprises a transition section. In some cases, the transition section bows inward towards the elongated body when the balloon is uninflated and/or inflated. Additionally, the elongated body preferably does not extend distally past the distal end of the first hemisphere.

Abstract: A method of applying a coating material to a stent includes the steps of providing a generally tubular stent having an inside surface and an outside surface and applying a coating material to the inside surface of the stent without applying that coating material to the outside surface of the stent. The method may comprise providing a mandrel having a diameter less than an interior diameter of the stent, providing the coating material around the mandrel, placing the stent around the mandrel and crimping the stent so that the inside surface of the stent contacts the coating material. Alternatively, the method may comprise providing an expandable device, providing the expandable device with the coating material such that the coating material is deliverable from the expandable device, placing the stent around the expandable device and expanding the expandable device such that the expandable device contacts the inside surface of the stent.

Abstract: Pharmaceutically acceptable hydrogel polymers of natural, recombinant or synthetic origin, or hybrids thereof, are introduced in a dry, less hydrated, or substantially deswollen state and rehydrate in a physiological environment to undergo a volumetric expansion and to affect sealing, plugging, or augmentation of tissue, defects in tissue, or of organs. The hydrogel polymers may deliver therapeutic entities by controlled release at the site. Methods to form useful devices from such polymers, and to implant the devices are provided.

Abstract: Relatively pain free vaginal dilation is obtained by inserting into the vaginal canal a variable rigidity vaginal dilator having an inflatable balloon, in a manner that avoids insertion into the urethra. Air is introduced into the balloon. When the patient has gained confidence in the pain free use of the dilator, the balloon is deflated to remove the air and water is introduced into the balloon to expand it so that it contacts the vaginal canal and exerts a pressure thereon. This contact is maintained for a period of up to about 15 minutes. The pressure and/or contact time is stepwise sequentially increased to a maximum of about 12 atmospheres and a contact time of up to about 45 minutes, in accordance with a regimen and instructions established by the patient's healthcare provider and tailored to the patient's specific needs. A preferred embodiment of the dilator and a kit employing same, useful in the method of the invention, are disclosed.

Abstract: Gastric space occupying devices are provided that include a stent configured for deployment in the gastrointestinal tract of a patient, and in particular, for deployment in the esophagus or the stomach. Secured to the stent is an expandable member that is adapted to reside within the patient's stomach. When expanded, the expandable member occupies a predefined volume within the patient's stomach and is further tethered to the deployed stent, thereby retaining or anchoring the expandable member within the stomach. Methods and systems for the deploying the space occupying devices are also provided.

Abstract: Devices and methods that may be employed to detect and/or prevent intraoperative full thickness penetration of anatomic walls, and to provide delineation of anatomic structures during surgery.

Abstract: A rectal balloon apparatus has a shaft with a fluid passageway extending therethrough. A balloon is affixed over an end of the shaft such that the fluid passageway communicates with an interior of the balloon. The balloon has a laterally flat surface thereon when inflated. The laterally flat surface of the balloon has a longitudinal groove formed thereon. The balloon having a pair of bulges formed thereon when the balloon is inflated. A ring is affixed to the shaft adjacent the balloon. The shaft has a plurality of holes formed thereon opening to an interior of the balloon.

Abstract: Devices and methods for delivering and placing a surgical sling without resorting to an abdominal incision are disclosed.

Abstract: Methods, systems and devices for performing gynecological procedures. According to one embodiment, there is provided a device for accessing the peritoneal cavity of a patient by inserting the device through the vaginal cavity, the cervix, and the uterus and past the fimbria.

Abstract: There is disclosed an apparatus, a system and a method for treating a sexual dysfunctional female patient. The apparatus comprises at least one expandable prosthesis adapted for implantation in female erectile tissue and adapted to be adjusted to temporarily achieve enlarged status of the female erectile tissue.

Abstract: A device for occluding the fallopian tube including a retention member and a mesh material supported by the retention member. The retention member has a first lower profile configuration for delivery and a second expanded configuration for placement within the fallopian tube. The mesh material is configured to block passage of an egg through the tube. The member has a plurality of tube engagement members to secure the retention member to the fallopian tube.

Abstract: A method of treating a vein comprises accessing a vein at an access point spaced from a sapheno-femoral junction. A bioabsorbable fibrous body is implanted into the vein through the access point. The body is moved in the vein toward the sapheno-femoral junction.

Abstract: In some embodiments, a method includes extending a dilator into a body of a patient in a first direction such that a distal end portion of the dilator extends from the body. The dilator defines a lumen therethrough. At least a portion of the dilator is disposed within the body when the distal end portion extends from the body. At least a portion of an implant is passed through the lumen defined by the dilator. The dilator is removed from the body by moving the dilator in the first direction.

Abstract: Disposable gynecologic instrument for dilation of body cavities by fluid injection, the construction according to the invention, include the instrument body (1) to which it has from the bottom tightly fixed a handle (2) with the reservoir (3) whilst is on the frontal part ??f the instrument body (1) projected is the trigger (4) positioned slidingly and designed for pressing with two fingers, which is by screw (41) connected to the main piston (42) movable within the cylinder, around which is placed a bigger spring (43) and where the outlet of cylinder is connected to one branch of the three-way pipeline (44), the other two of which are connected, one on the upper irreversible valve (12), and the other to the lower irreversible valve (22); and where is also on the front side of the instrument body (1) by screw thread and sealingly attached the main pipe (5), formed with longitudinal ribs (51) positioned crosswise and a series of aslope placed ribs (52) of circular perimeter, which increase the stiffness of the

Abstract: Apparatus is provided for use with a subject's body, vagina, vaginal fornix, uterus, and uterine artery. A fornix-engaging structure is inserted into the vagina and engages the vaginal fornix. A rod is inserted into the subject's body via the fornix-engaging structure, such that a distal end of the rod passes through vaginal tissue at a first vaginal site until the distal end of the rod is at a first extrauterine site outside of the uterine artery, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid. A rod-guide is coupled to the fornix-engaging structure, and guides the distal end of the rod to the first extrauterine site. A uterine artery compression device is disposed on the distal end of the rod. Other embodiments are also described.

Abstract: Methods and apparatus of forming hydrogel systems in situ are provided using a delivery system configured to deliver two or more fluent prepolymer solutions without premature crosslinking. The delivery system comprises separate first and second lumens coupling first and second inlet ports and first and second outlet ports, respectively, and may include a balloon, flexible distal region, mixing chamber or steerable distal end. Multi-component hydrogel systems suitable for use with the inventive methods and apparatus are also described.

Abstract: Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. Patient benefit is achieved through improved outcomes, reduced pain, especially peri-procedural pain, and reduced recovery times. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic. Distension is achieved mechanically, rather than with liquid distension media, thereby eliminating the risk of intravasation.

Abstract: Embodiments described herein comprise an apparatus and method for preventing fluid from flowing through the vagina. The apparatus comprises an introducer for inserting into the patient's vagina. The apparatus may further comprise an expandable device coupled to the introducer. The expandable device may be configured to expand into a substantially sealing engagement with an inner wall of the patient's vagina once the introducer is located within the patient's vagina. The expandable device may be capable of maintaining a fluid pressure in the abdominal cavity of the patient after a fluid connection has been made with the vagina and the abdominal cavity.

Abstract: A device useful for treating an aneurysm having a neck comprises a first inflatable disc and a second inflatable disc, said second inflatable disc being adjacent to said first inflatable disc and in fluid communication therewith. The inflatable discs are sized and constructed such that when the inflatable discs are inflated, the aneurysm neck is engaged therebetween. The inflatable discs may include at least one wall that is substantially inelastic and may include an internal member limiting expansion of the inflatable disc in a direction parallel to the device axis. The inflatable discs may have an aspect ratio greater than 3.

Abstract: A device for enlarging a canal of a human or animal subject includes an elongate member having a first lumen extending therein and an inflatable body toward a distal end of the elongate member. The inflatable body is deliverable, in an uninflated or deflated state, to a location substantially within the canal prior to inflation. The first lumen is in communication with the inflatable body via one or more channels therebetween. In use, the first lumen is in communication, toward a proximal end, with an inflation system for delivering fluid to inflate the inflatable body and thereby enlarging the canal. The device may include markings for sounding of e.g. uterine depth. The device may also include one or more projections, or other structure providing tactile cues during positioning of the device within the canal and these may also be configured to aid in removal of cells from a tissue wall.

Abstract: An implantable sterilization device may include a ring having an inner diameter, a core slidable through the inner diameter of the ring, and a tissue securing element, at least part of which is positioned between the ring and the core. A method of closing a fallopian tube may include providing a closure system including a handle, a flexible shaft connected to the handle, and a sterilization device detachably connected to the flexible shaft, inserting the flexible shaft into the lumen of the fallopian tube and advancing the flexible shaft into the lumen; compressing a portion of the wall of the fallopian tube with the sterilization device to secure the sterilization device relative to the fallopian tube, blocking the lumen of the fallopian tube with the sterilization device; and separating the sterilization device from the tube.

Abstract: Apparatus for preventing fluid transfer through an opening connecting an oviduct to a uterine cavity includes a body having a base with a periphery and a seal carried by the body for overlying and engaging uterine tissue leading to the opening. The seal receives fibroblast in-growth to create a hermetic seal between the oviduct and the uterine cavity. A peripheral anchor portion extends from the base for securing the body to the uterine tissue leading to the opening, the base overlying the opening.

Abstract: Disclosed is an apparatus for deploying a bronchial isolation device in a bronchial passageway in a lung of a patient. In one embodiment, the apparatus includes an outer shaft having a distal end. A housing is coupled to the distal end of the outer shaft and configured to receive the bronchial device. An inner shaft is slidably disposed within the outer shaft. A handle is adapted to move the outer shaft relative to both the inner shaft and the handle while the inner shaft remains fixed relative to the handle so as to eject the bronchial isolation device from the housing.

Abstract: A dual balloon catheter apparatus for controlling postpartum hemorrhage in uterine or vaginal cavities or hemorrhage in other body cavities, comprising: (1) a catheter having an inflation lumen and a deflation lumen; (2) a first inflatable balloon in fluid communication with the inflation lumen; and (3) a second inflatable balloon encompassing the first balloon and in fluid communication with the deflation lumen. A first fluid inflation medium can be introduced from an external fluid source through the inflation lumen to inflate the first balloon, so as to apply a substantially even pressure along a substantial portion of a uterine cavity to reduce or eliminate bleeding along such inner surface. The second inflatable balloon functions to confine any first fluid inflation medium that escapes (e.g., by leakage or rupture) from the first balloon, and to discharge such medium through the deflation lumen.

Abstract: Relatively pain free vaginal dilation is obtained by inserting into the vaginal canal a variable rigidity vaginal dilator having an inflatable balloon, in a manner that avoids insertion into the urethra. Air is introduced into the balloon. When the patient has gained confidence in the pain free use of the dilator, the balloon is deflated to remove the air and water is introduced into the balloon to expand it so that it contacts the vaginal canal and exerts a pressure thereon. This contact is maintained for a period of up to about 15 minutes. The pressure and/or contact time is stepwise sequentially increased to a maximum of about 12 atmospheres and a contact time of up to about 45 minutes, in accordance with a regimen and instructions established by the patient's healthcare provider and tailored to the patient's specific needs. A preferred embodiment of the dilator and a kit employing same, useful in the method of the invention, are disclosed.

Abstract: Apparatus, methods and kits which, when installed or used, occlude or partially occlude a cervical canal, the internal opening of a cervical canal (cervical os), or a uterine side wall rupture location, such as to inhibit or prevent bacterial access and retard leakage of amniotic fluid resulting from PROM. The present apparatus can include an expandable support member of a biocompatible and non-toxic material. In some examples, the support member can include a top portion having a first diameter and a bottom portion having a second diameter less than the first diameter. In some examples, the support member can include an expandable stent of a suitable length and uniform diameter to be inserted in a non-dilated cervical canal or transabdominal access route. In various examples, the apparatus further includes a fluid-resistant fabric, polymer, substance or other material placed over at least the top portion of the support member.

Abstract: Sexual stimulation devices and methods that provide highly varied and dynamically controllable sensations, both directly under manual control of the user and indirect electronic control, and in such a way as to provide sensations to specific regions of the sexual organs.

Abstract: Pharmaceutically acceptable hydrogel polymers of natural, recombinant or synthetic origin, or hybrids thereof, are introduced in a dry, less hydrated, or substantially deswollen state and rehydrate in a physiological environment to undergo a volumetric expansion and to affect sealing, plugging, or augmentation of tissue, defects in tissue, or of organs. The hydrogel polymers may deliver therapeutic entities by controlled release at the site. Methods to form useful devices from such polymers, and to implant the devices are provided.

Abstract: Devices for controlling prolapse. The device includes a base, first and second lobes which protrude from a midsection of the base, and an anchoring knob distal the base. Various portions of the device are inflatable to and are inflated by way of an inflation tube and an inflation device. Some versions of the device include a base, an anchoring knob, and a shat that extends between and connects the base and the anchoring knob, again with portions thereof being inflatable.

Abstract: Apparatus is provided, including a tube (22) that is configured to pass into a patient's vagina (26) and to penetrate vaginal tissue (24) until a distal tip (36) of the tube is outside of a uterine artery (28) of the patient, but in a vicinity of a portion (38) of the uterine artery that supplies a uterine fibroid (30). A balloon (40), disposed at the distal tip, is inflated to cause local squeezing of the portion of the uterine artery to an extent sufficient to occlude the uterine artery. Other embodiments are also described.

Abstract: Composite fiber reinforced balloons for medical devices prepared by applying a web of fibers to the exterior of a preformed underlying balloon and encasing the web with a matrix material to form a composite balloon. The fiber web is applied to at least the cone portion of the underlying balloon form. Either the cone portion of the underlying balloon form, or the web fibers applied to said cone portion, or both, have a friction-enhancing material coated thereon.

Abstract: A flexible cardiac catheter for sensing electrical activity within and administering therapy to a patients' heart has a series of flexible, conductive electrode bands positioned in grooves in the catheter's tubular body. The bands consist of alternating flexible and conductive elements, providing flexibility and overall versatility to the catheter. The electrode bands have controllable flexibility due to the elastic properties of the flexible elements and continuous uninterrupted electrical current conductance from the one-piece design of the conductive element. The synergy of the components of the composite flexible and conductive bands will help solve problems current electrode bands have and will allow for a freedom in the design of catheter electrode band configurations in the future.

Abstract: Devices and method for occluding a fallopian tube. The devices, in one embodiment, may include a plurality of expandable occluding members coupled by respective dissolvable connecting members.

Abstract: A method of treating tissue comprises introducing into a hollow organ a support device and, after insertion, arranging the support device into a non-yielding configuration substantially filling the hollow organ and substantially preventing walls of the hollow organ from moving inward in combination with inducing contraction of the hollow organ around the support device to cut off blood flow through at least a portion of the walls of the hollow organ and removing the support device after blood flow has been cut off for a predetermined time.

Abstract: The stimulator includes a first resilient cylindrical (phallic-shaped) end and a second, shorter resilient cylindrical end with an expandable-deflatable bulb disposed therein. A truncated U-shaped stimulator is formed by a base connecting the ends. One embodiment permits manual bulb contraction and resilient material expansion with air or fluid ejection/admission. Another embodiment inflates the bulb manually with pressurized air/fluid (orally) with a one-way valve and user controlled valve release, or inflates the bulb with a pump. An external or on-board pump maybe used. The on-board internal pump has a depressible wall pump bladder on the stimulator. The inflatable-deflatable bulb maybe connected to the base via a reduced diameter neck. A method controllably inflates and deflates the bulb and changes its cross-sectional dimensions under user controls.

Abstract: A pessary comprising a main stem and an inflatable bladder disposed about the proximal larger diameter section of the main stem. The main stem further comprises 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: An improvement on the extra-amniotic balloon and technique of placement is disclosed. It involves a large capacity balloon, modified to efficiently place pressure on the cervix, and markers for ease and of placement. The malleable introducing stylet allows for safe and easy insertion, either manually or visually, through a cervix that is 0.5 cm or more in dilation. The optional traction collar can aid in more efficiently placing pressure on the cervix. The automatic pump for instillation of the fluid has a forward and reverse mode to allow for deflation and repositioning of the balloon if placement is less than optimal. This process can be performed by a physician or a nurse, already certified in the placement of fetal scalp electrodes or intrauterine pressure catheters. Additionally, the procedure can be performed by one person.

Abstract: An apparatus and method for dilating a body canal such as a cervix is provided. The apparatus includes a threaded cylindrical rod with an inflatable member at one end. The apparatus also includes a tubular member with a threaded bore that is capable of threaded engagement with the threaded rod.

Abstract: This invention is an improved balloon catheter for cervical dilation. This catheter has a balloon that is passed through the cervix of a pregnant woman, and the balloon is then inflated with 100-120 ml of sterile water or normal saline. The improved disc shape of the inflated balloon is 8 cm in diameter and 3-4 cm in height. The balloon will sweep the amniotic membrane away from the cervix, causing the release of prostaglandins which helps ripen the cervix and initiates uterine contractions. The improved shape of the balloon causes the cervix to be 6-8 cm dilated once it is expelled. This catheter also contains a flexible guidewire that allows for easier insertion for the provider, and makes insertion less painful for the patient because it can be placed without a speculum and ring forcep being used. This catheter could actually be placed on an outpatient basis or in the doctor's office, with the patient instructed to go to the hospital or birthing unit when the catheter falls out.

Abstract: Articles and procedures for preventing or treating vaginal prolapse, urinary incontinence, and other disorders of the pelvic floor.

Abstract: Medical devices for filtering fluids flowing through a lumen and a method of forming medical devices. The devices can be used in vascular channels, urinary tracts, biliary ducts and the like, and filter emboli and other debris generated at a treatment site.