Retention devices and methods are provided for drug delivery. The device may include a housing configured for intraluminal deployment into a human or animal subject and at least one reservoir contained within the housing. The at least one reservoir may have an actuation end and a release end and contain at least one drug formulation. A plug may be contained within the at least one reservoir and be moveable from the actuation end toward the release end. The device may also include an actuation system operably connected to the actuation end of the at least one reservoir and configured to drive the at least one drug formulation from the reservoir. The device may also include at least one retention member affixed to the housing and movable between a non-stressed position, a deployment position, and a retention position for retaining the device in an intraluminal location in the subject.

In various embodiments of the invention, a manipulator attaches to and allows a sheath to be positioned inside the cervix and a catheter to thereby be inserted through the sheath and be positioned in a desired location in the uterus. In various embodiments of the invention, the manipulator may be attached or permanently connected to the sheath. In various embodiments of the invention, the sheath is fenestrated to allow the catheter to be detached from the sheath. In various embodiments of the invention, the manipulator allows the sheath to be positioned through the cervix canal to allow for catheter transmitted intrauterine pressure monitoring or balloon catheter assisted ripening of the cervix.

Devices and methods are provided for drug delivery. The device may include a housing configured for intraluminal deployment into a human or animal subject and first and second reservoirs within the housing, each reservoir having an actuation end, an opposed release end, and a plug moveable from the actuation end toward the release end. First and second drug formulations may be contained in the first and second reservoirs, respectively. The device may also include one or more actuation systems configured to drive the first and second plugs so as to drive the first and second drug formulations from the first and second reservoirs. The housing may include a porous membrane sidewall in fluid communication with the release ends of the first and second reservoirs, the porous membrane sidewall being configured to distribute the first and second drug formulations driven from the first and second reservoirs.

Devices, systems for localized delivery of a chemotherapy, hormonal therapy or targeted drug/biologic therapy to a target tissue area of an internal body organ of a patient. A catheter 10 forms a sealed treatment chamber in a natural lumen extending through the target tissue area. Air is purged from the chamber, which is then filled with a liquid drug solution for an adequate treatment session time, solution volume and drug concentration to saturate the target tissue area, thereby providing the treatment. The liquid drug solution may be circulated or recirculated through the chamber or maintained stationary therewithin. The drug may saturate the target tissue area and pass therethrough into the lymphatic system or interstitial space, which may serve as a reservoir of the drug for continued therapeutic treatment after withdrawal of the catheter. The chamber is evacuated at the end of the treatment session.

Transcervical access systems for providing transcervical movement of fluids are described. The transcervical access systems are effective for transferring a broad range of fluids, including the delivery of hydrogel precursors, saline, and imaging fluids, to the uterine cavity. The transcervical access systems are also effective for removing fluids from the uterine cavity, such as residual bodily fluids, residual fluids from a procedure, or tissue. The transcervical access systems described include flow limiters, such as egress limiters and/or cervical plugs. Methods of use of the transcervical access systems are also described. Methods include using the transcervical access systems to transcervical access the uterine cavity and install hydrogel. The transcervical access systems and associated methods can be useful for providing degradable hydrogel in the uterine cavity, including the cervical canal, for the prevention of adhesions following intrauterine procedures.

A device for managing postpartum hemorrhage is described. The device comprises an intrauterine balloon that may be deflated when inserted into a uterine cavity. The intrauterine balloon may be inflated inside the uterine cavity. The device also comprises a drug delivery vehicle that may be deposited on an outer surface of the intrauterine balloon by a coating technique or an eluting technique. The drug delivery vehicle may release a hemostatic drug into the uterine cavity. The device additionally comprises a cervical barricade that may retain the released hemostatic drug in the uterine cavity. The cervical barricade may be a cone-shaped plug that tapers proximally to conform to a contour of a vagina. The device further comprises a catheter that may be used to inflate the intrauterine balloon, deflate the intrauterine balloon, and support the cervical barricade.

A medical device including an introducer; a first section configured to connect to a supply of therapeutic fluid; and a second section configured to connect to a supply of therapeutic elements. The therapeutic elements are drawn into the introducer by way of suction created by a flow of the therapeutic fluid through the introducer. The therapeutic elements are drawn into the introducer by way of suction created by a flow of the therapeutic fluid through the introducer.

A method for operating a fluid management system includes automatically detecting an unstable condition in the system, which may include detecting a large change in the supply fluid amount (indicative of a bag change), detecting a large change in the waste fluid amount (indicative of a bag change), or detecting a large difference between the amount of fluid dispensed as measured by the weight data and the amount of fluid dispensed as measured by the flow data (indicative of a blockage in the supply tubing). The method further includes adjusting the operating mode of the system during the unstable condition, which may include switching to using flow data rather than weight data to track the fluid deficit during a supply bag exchange, halting operation of an outflow pump during a waste container exchange, and/or halting operation of the system during a blockage in the supply tubing.

A system for accessing a patient's uterine cavity and detecting perforations in the uterus includes an elongated probe having a flow channel extending to a terminal outlet in a distal region of the probe. A fluid source is coupled to the flow channel, and a seal on the probe is positionable in an endocervical canal. The probe may be trans-cervical inserted into the uterine cavity, and a fluid may be introduced through the channel to flow outwardly from the terminal outlet into the uterine cavity. A parameter of said fluid flow is monitored to detect a perforation in the uterus.

A cervical dilator is positioned in the cervix of a subject, as an outpatient procedure. Then, the cervical dilator is inflated by adding water to begin expansion of an expandable material located within the patient’s cervix. The expandable material expands the cervical dilator balloon at a rate of 1-3 mm/hr until a cervical dilation to 3 cm is obtained, typically at the subject’s home overnight prior to starting induction of labor or other procedures where cervical dilation in needed.