Abstract: Uterine toner device (UTD) for reducing postpartum hemorrhage includes fundal, cervical, vaginal, and nipple portions with cylindrical and tubular shaped bodies. The fundal and cervical portions include fenestrations. The diameters for fenestrations in the fundal portion are larger than those in the cervical portion. An indication resides between the fundal and cervical portions for proper placement. When the nipple portion couples to a pressure pump's suction tube and negative pressure is applied, cervical tissue is drawn into the fenestrations in the cervical portion resulting in contraction and retraction of the uterus, stopping any bleeding. The pressure pump is automatically shut-off after a pre-set period of time to avoid prolonged ischemia. A balloon at the cervical portion assists in the release of the cervical tissue when inflated. During a C-section, an introducer may be used in combination with the UTD to assist in introducing the suction tube through a tight cervix.

Abstract: A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location, and expanding the prosthetic heart valve and the expansion device from the compressed configuration to an expanded configuration. The expansion device includes an inner expandable member and a plurality of outer expandable members. The outer expandable members are distributed such that there are gaps providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.

Abstract: A cervical dilator including a stem comprising a partly or fully dehydrated hydrogel comprising a water-insoluble synthetic hydrophilic polymer capable of radial expansion due to absorption of water from a bodily fluid. The cervical dilator softens and ripens the cervical tissue and expands the cervical canal by a combined action of radial hydrogel stem expansion and osmotic withdrawal of water from the tissue. The osmotic withdrawal is caused by at least one osmotically active compound, such as a water-soluble salt, a polyelectrolyte, or a mixture thereof, wherein the at least one osmotically active compound is dispersed in the hydrogel. The cervical dilator may also include a non-toxic plasticizer of the hydrogel, such as water.

Abstract: The disclosure provides for a device and method for dilation. The dilation device may include a catheter body having a proximal portion and a distal portion, a dilation expandable body in fluid communication with a first opening on the distal portion of the catheter body, and an occlusion anchor expandable body in fluid communication with a second opening on the distal portion of the catheter body. The method for dilating a stricture site may include inserting the dilation device into a stricture site of a patient, expanding the occlusion anchor expandable body at the stricture site, and expanding the dilation expandable body at the stricture site.

Abstract: A bleeding control device for mitigating bleeding includes an outer storage container housing, a compressed gas canister, wound blocking contents and a control element. The bleeding control device may be used to deliver variable contents to a wound at the site of injury to control the bleeding of a victim as temporary solution for mitigating the bleeding until more advanced medical care can be provided. A bleeding control device includes a canister housing, a compressed gas canister arranged within the canister housing, a tube connected to the canister housing, an inflatable balloon disposed on the tube, the inflatable balloon being fluidly connected to the compressed gas canister, and a control element configured to activate the compressed gas canister to inflate the inflatable balloon.

Abstract: A trocar assembly includes a housing, an elongated cannula extending from the housing to an insertion tip, and skirt. The skirt has a leading end portion and a trailing end portion. The leading end portion is secured to the insertion tip. The skirt has an outer surface supporting an antimicrobial material and an inner surface supporting a medical adhesive material.

Abstract: Apparatus and methods are provided for flaring a stent deployed within a branch vessel including an ostium communicating with a main vessel, a first end of the stent extending at least partially from the branch. A catheter is provided that includes a first balloon carried on its distal end, and a second balloon that includes a distal section overlying at least a portion of the first balloon and a proximal section. The catheter distal end is introduced into the main vessel and positioned through the ostium and stent into the branch until the first balloon is disposed within the stent. The first balloon is expanded to anchor the stent, and the second balloon is expanded to flare the first end of the stent. Optionally, the first balloon is expanded further, e.g., to expand the stent within the branch body lumen and/or dilate the lesion.

Abstract: A uterine manipulator device useful for laparoscopic hysterectomy procedures or other minimally-invasive gynecologic procedures.

Abstract: A device can be used for both tissue expansion within a body of a patient as well as a permanently implanted prosthesis. Such a device can include an expandable elastomeric matrix and granules of a solute embedded within the matrix. The matrix can define boundaries of a plurality of chambers within the matrix. The device, when implanted within the body of the patient, can be exposed to fluid within the patient to create an osmotic gradient across a boundary of the device. Based on the gradient, fluid permeates the elastomer and gradually expands the chambers. The rate of expansion can be programmed to allow the body to naturally adapt to the volume, which increases until achieving a target volume in an expanded state.

Abstract: A cervical dilator and methods of using the cervical dilator include guiding a shaft and a balloon of the cervical dilator through a cervix to seat the balloon in an uninflated state within a cervix. Seating the balloon includes locating proximal and distal ends of the balloon near proximal and distal ends of the cervix such that the balloon fills a canal of the cervix. After seating the balloon within the canal of the cervix, the method includes introducing a predetermined amount of fluid into the balloon cavity to fill the balloon to an inflated state. While the balloon is in the inflated state, the method includes waiting a predetermined time period to allow cervical dilation. After waiting the predetermined time period, the method includes applying light tension to the exterior surface of the shaft to remove the shaft and the balloon in the inflated state from the cervix.

Abstract: Methods, devices and systems for delivering a device assembly into a gastric or other space within the body, allowing the device to expand to occupy volume within the gastric space and, after an effective period of time, delivering a substance or stimulus to begin breakdown of the expanded device so that it may release from the body.

Abstract: An implantable device for controlling hemorrhage in a body cavity comprising an expandable balloon and a conduit for supplying a physiologically compatible fluid to inflate the balloon is described. The balloon tamponade device is inserted into the body cavity and is inflated with a physiologically suitable fluid so that the balloon generally conforms to the body cavity and exerts compressive force against the walls, tissues or structures of the body cavity to control hemorrhage. The balloon may have a deforming means to limit expansion of the balloon in a direction to facilitate expansion of the balloon in another direction. The device may have additional tubes within the conduit, or a plurality of separate lumens within the conduit or tubes to allow drainage and irrigation to the body cavity. A method of controlling hemorrhage in a body cavity by using the implantable device is also contemplated.

Abstract: A method and system of providing therapy to a patient's uterus. The method can include the steps of inserting a uterine ablation device into the uterus; expanding a distal anchor; inflating a proximal balloon to pull the distal anchor proximally and seat the distal anchor against the internal os of the uterus; inflating a central balloon to seal the cervix; delivering vapor from the uterine ablation device into the uterus; and condensing the vapor on tissue within the uterus. The can include a cervical collar adapted to place a distal portion of the device within the uterus when the cervical collar contacts an external os of the cervix.

Abstract: Medical devices which are adapted to be implanted into a patient for a limited period of time using minimally invasive insertion procedures for dilating a stenotic opening, such as a stenotic sinus opening, are provided. The devices and methods can be used for treating sinusitis and other nasal and/or sinus disorders.

Abstract: Contraceptive and/or sterilization methods and devices are disclosed which may improve the speed of tubal occlusion and mechanisms for anchoring for a contraceptive device. In accordance with some embodiments, improvements may be made to the delivery catheter to induce trauma and create faster tubal occlusion, improvements may be made to the occlusion device to prevent migration and induce trauma, and improvements may be made to the occlusion device to reduce the total volume of in-growth required compared to conventional expansive occlusion devices.

Abstract: An improved device for the management of a patient's uterine hemorrhage has improvements that include: (a) an inlet valve for controlling the flow of fluid into an expandable vessel, (b) an adapter having a free end and a connection end that connects to the third opening in a tube that has openings at each of its ends, (d) a pressure release component that connects to the adapter's free end and provides for the automatic release of a quantity of fluid sufficient to maintain an approximate, steady state, uniform operating pressure within the device, and (e) an attachment means that affixes the free end of the expandable vessel to the tube at a point that is distal from a tube end so that a portion of the tube extends into the expandable vessel and can be used as a core to assist with the placement of the vessel into the patient's uterine cavity prior to its inflation.

Abstract: Methods, systems and devices for endometrial ablation. In accordance with a method, a working end of an RF ablation device is positioned in a patient uterus to contact endometrial tissue, the working end comprising a dielectric wall capable of non-expanded and expanded shapes and for conforming to an asymmetric or symmetric shape of the patient's cervix. An expandable seal is provided for sealing the cervical canal.

Abstract: Materials and Methods for producing localized hypothermia in a patient for treatment of a weight disorder (e.g., obesity).

Abstract: The present disclosure relates to a hydrogel composition and methods of using the same. The hydrogel composition may include precursors that react with each other upon contact as well as precursors that react upon contact with an initiator. In embodiments, the resulting hydrogels may have varying levels of crosslinking with both denser and less dense regions.

Abstract: A medical device for blood flow restoration and/or for use as an implantable member in a human vessel includes a self-expanding member, a guidewire, and a connection mechanism. The self-expanding member includes a plurality of cells and filaments having specific ranges of thicknesses, widths, and heights. The self-expanding member can take on a volume-reduced coiled form with overlapped edges, and can generate optimal radial forces against a vessel wall and/or thrombus when deployed and expanded.

Abstract: Everting balloon systems and methods for using the same are disclosed. herein. The systems can he 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 delivery system for delivering an occluding device to a body lumen comprises an elongated shaft having a proximal end and a distal end, a delivery means for delivering the occluding device to a desired location within the body lumen, and a flexible atraumatic tip on the distal end of the elongated shaft. The distal end of the elongated shaft is insertable into the body lumen. The atraumatic tip is configured to guide the elongated shaft through the body lumen while avoiding perforation of the body lumen.

Abstract: The present invention provides various systems, a kit, and a method for accessing, sampling within, and visualization of areas within the mediastinal cavity for assisting a surgeon in performing a mediastinoscopy procedure. The access system includes one or more preferably toroidal balloons that can be expanded to dilate and protect the inner walls of a bodily conduit. Instruments pass through hollow spaces within the expanded toroidal balloons. The proximally positioned balloons are expanded first and the unexpanded balloons to be positioned distally are passed through them and subsequently expanded. The sampling system includes an instrument with a rounded head having two or more jaws and a slit therein at the distal end of an elongated tubular body. The visualization system includes a 360° camera that can be positioned from proximal to distal a target site and can also do a U-turn about its axis of extension.

Abstract: A method of treating early papillomavirus infection of an orifice of a human or animal body including any canal associated with an orifice, comprising applying a viral inactivation agent to the orifice and/or canal in an amount effective to inactivate a portion of the virus infecting the orifice or canal. Apparatus is also disclosed.

Abstract: A system for treating uterine tissue having a seal assembly configured for positioning in a patient's cervical canal and uterine cavity; an expandable distal balloon portion; an expandable elongate medial balloon portion configured for movement between a first transversely expanded shape for engaging a cervical canal and a second transversely non-expanded shape for trans-cervical insertion; and a fluid source in communication with distal balloon portion and medial balloon portion for expansion of said balloon portions.

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 delivery assembly (10) for an implant (30) includes a release mechanism with a locking element (52) and a blocking member (56). The locking element (52) includes a latching pin (14) that engages with an eyelet (54) in the implant (30) to attach the implant (30) to a distal end of an inner catheter (36). The blocking member (56) prevents premature disengagement of the latching pin (14) from the implant (30). Withdrawal of the blocking member (56) allows disengagement of the latching pin (14). The locking pin (52) and the blocking member (56) extend along the lumen of the inner catheter (36) from a handle (12) such that a guide wire (34) is also able to extend through the lumen of the inner catheter (36). The locking pin (52) and the blocking member (56) preferably have a crescent-shaped transverse cross section. The release mechanism allows retrieval of the implant (30).

Abstract: The present invention is directed to a novel device and method for providing a disposable endotracheal intubation device for use with an auxiliary passageway serving as a guide for the placement of an orogastric or other enterally directed device in a patient. The present invention pertains to a medical catheter device, removably attachable to an endotracheal tube, for guiding the path of an enteral tube into the esophagus of a patient. The catheter device preferably employs an adjustable clamp to fix the position of the catheter relative to the endotracheal tube. The present invention also pertains to a combination medical intubation device comprising an endotracheal tube and a catheter proximate the endotracheal tube to guide the path of an enteral tube. The present invention also pertains to a method of intubating a patient using this combination medical intubation device.

Abstract: Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. The system is configured to permit simultaneous tissue cutting and removal from a target site. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic.

Abstract: Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. An access sheath is provided with at least one lumen, and a lens attached thereto. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic.

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: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

Abstract: Devices and methods for determining fallopian tube occlusion. The methods may include determining fallopian tube occlusions through a pressurization or volumetric determination.

Abstract: The present disclosure relates to a hydrogel composition and methods of using the same. The hydrogel composition may include precursors that react with each other upon contact as well as precursors that react upon contact with an initiator. In embodiments, the resulting hydrogels may have varying levels of crosslinking with both denser and less dense regions.

Abstract: The invention is incorporated into a tissue removal and manipulation device for vaginal hysterectomies and related surgeries. The present invention solves the suturing problem of the prior art devices by providing a device that not only can manipulate the uterus during surgery but remove the uterus without the need for suturing.

Abstract: Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. The system and devices provide simplified use and reduced risk of adverse events. 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. An intrauterine access end procedure system includes a mechanical distension element, to eliminate the need for liquid distension media at pressure sufficient to create a risk of intravasation.

Abstract: A cup-like structure for engaging a cervix of a patient includes a rim, and includes a base defining an aperture through which one or more tubular members of a uterine manipulator may extend into the uterus. The cup-like structure is made from one or more of a polyphthalamide (PPA) material and a polyetheretherketone (PEEK) material. A uterine manipulator including a cup-like structure is also disclosed.

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: The Vas Deferens or Fallopian tubes valve system incorporates a small valve in line with either the Vas Deferens or the Fallopian tube in order to open or close fluid communication therein, and effectively a form of birth control. The valve is installed on either one of the Fallopian tubes or Vas Deferens, and is manually or remotely controlled. The small valve is manually controlled via an arm that can be manually rotated to open or close the valve seated there under. A magnetic version of the small valve incorporates magnets on the arm in order to induce motion of the arm upon focusing a magnetic field upon the valve. A remotely operable valve utilizes a solenoid and radio receiver to remotely operate the small valve.

Abstract: An environmentally sensitive hydrogel material swells or collapses in response to a parameter such as pH level associated with consumption of food by a patient. This swelling or collapsing is harnessed to treat morbid obesity or some other condition of the patient. The swelling or collapsing of the hydrogel may be used to tighten a gastric band or gastric valve when the patient starts eating; then loosen the band or valve when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to increase the size of a space occupying device in the patient's stomach when the patient starts eating; then decrease the size of the space occupying device when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to selectively restrict the absorption of nutrients within a patient's gastrointestinal tract, such as in the duodenum.

Abstract: Devices and methods for determining fallopian tube occlusion. The methods may include determining fallopian tube occlusions through a pressurization or volumetric determination.

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: Devices and methods are disclosed for the delivery of an implant into small bodily spaces. The delivery devices include an expandable portion configured for placement within such bodily spaces and subsequent expansion to facilitate the delivery of the implant.

Abstract: Systems and methods of visibly marking a reproductive tract, e.g., at least one ostium of the Fallopian tubes accessed transvaginally and transcervically, to indicate delivery of an occlusion device into the corresponding at least one Fallopian tube to effect contraception are disclosed. Marking is effected by delivery of a dye that stains the ostium and/or extension of the marking member from the delivered occlusion device into view in the uterine cavity or ostium. A catheter (or catheters) preferably introduced through a hysteroscope that illuminates and provides visualization of the uterine cavity and the ostia of the Fallopian tubes is employed to insert each contracted, stent-like, occluding device into each Fallopian tube and to mechanically expand or release to self-expand the occluding device.

Abstract: A cervical dilator for use in dilating a cervix comprises a light weight flexible tube member. The cervical dilator also comprises a syringe connected to a first end of the flexible tube member for introducing a liquid or air solution into the tube member. The cervical dilator also includes a balloon arranged over an end of the tube that is inserted into the cervix of the patient in an uninflated state. The cervical dilator also comprises at least one orifice arranged through or near an end of the flexible tube member and within the interior cavity of the balloon, such that the air or liquid inflates the balloon to a predetermined diameter.

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: An applicator for delivering brachytherapy includes elongate members movable between collapsed and expanded configurations for delivering brachytherapy within a lumpectomy cavity, a vaginal cavity, or other target region. The elongate members may be expandable into a symmetrical or asymmetrical expanded configuration, e.g., into a generally spherical, pear-shaped, or planar configuration. A system for delivering brachytherapy includes the applicator and an access device for lining and/or dilating a body cavity and/or for receiving the applicator therein. The access device is advanced into a body cavity, an expandable member on the access device is inflated, the applicator is advanced into the access device, and the elongate members are expanded to deliver radiation to the target region.

Abstract: Stent devices comprising an inflatable inner balloon defined by an envelope and an outer balloon surrounding the inner balloon concentrically, the outer balloon serving as a therapeutic agent reservoir used for controlled therapeutic agent delivery. In some embodiments, the outer balloon has two separate walls which define its volume and is independently inflatable. In some embodiments, the two concentric balloons form a substantially cylindrical structure which has a proximal end and a distal end. A catheter carrying inflation and drainage lumens extends outward from the proximal end. In some embodiments, the distal end includes an embedded cervix accommodating tip or has a non-embedded cervix accommodating tip attached thereto. The stent devices can be used to maintain the integrity and placement of vaginally placed mesh or graft after reconstructive procedures, prevent vaginal hematoma formation and bleeding, provide pain control after surgery and deliver antibiotics or hormones to the vaginal epithelium.

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: 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.