Abstract: Embodiments of stents for treating congenital heart defects and related delivery systems are provided. The devices described herein are configured for insertion into a blood vessel lumen to maintain a patency of a conduit and to balance flexibility and radial resistive force for delivery through a microcatheter. The device described herein are configured to transition from a crimped configuration to an expanded configuration. In the crimped configuration, a crimped diameter of the devices is less than about 0.7 mm. In the expanded configuration, the devices are configured to have an expansion diameter of greater than about 3 mm measured at the body section. The devices described herein are configured to have a radial resistive force greater than about 0.20 N/mm at 1 mm of compression in the expanded configuration. Various devices having these features are described herein.

Abstract: Systems for the treatment and prevention of pelvic dysfunction are provided. In one embodiment, a vaginal dilation device includes a handle portion and a shaft portion. The shaft portion is configured to expand from a collapsed configuration to an expanded configuration. The shaft portion can include a distal tip region, a spine region, and a distal arm region connecting the distal tip region to the spine region. The spine region can extend distally from the handle portion to the distal arm region, and can be generally tubular in shape. The distal arm region can be generally conical in shape and be configured to provide a gradual increase in diameter from the distal tip region to the spine region. Methods of use are also provided.

Abstract: The devices and methods described herein are for use with conventional catheters and guidewires. Access can be maintained with the catheter and/or guidewire and the device can be backloaded onto the guidewire and into the catheter to be advanced to a target. The devices can include a tubular shaft having a lumen for receiving a guidewire; at least one aperture for receiving a feature of an implant positioned on the tubular shaft; and a plurality of relief cuts. The outer diameter of the tubular shaft is sized relative to an inner diameter of a catheter for receiving the tubular shaft, such that a sheath is not positionable in a lumen of the catheter when the tubular shaft is in the lumen of the catheter. The tubular shaft can be axially displaced in the lumen of the catheter to advance or retract the implant positioned on the tubular shaft.

Abstract: Described herein are variable diameter stents for insertion into a blood vessel lumen to provide a generally radially outward force on the blood vessel lumen. The stent may comprise a first end section comprising a first plurality of struts defining a first variable diameter; a second end section comprising a second plurality of struts defining a second variable diameter; a body section extending between the first end section and the second end section and comprising a third plurality of struts; and a device lumen extending through the first end section, the body section, and the second end section. In an expanded configuration, a first subset of the first plurality of struts is increased in length from the body section towards a proximal face, and a first subset of the second plurality of struts is increased in length from the body section towards a distal face.

Abstract: The systems, devices and methods to reduce trauma and injury to tissue during labor and delivery. In particular, the systems and methods relate to devices that retain dilation support devices, dilation devices, in place in the vaginal canal during the certain stages of labor. These devices retain the dilation device in the vaginal canal at therapeutically effective locations and maintain the dilation device in such positions for periods of time sufficiently long to allow the dilation device to have a therapeutic effect.

Abstract: Embodiments of stents for treating congenital heart defects and related delivery systems are provided. The devices described herein are configured for insertion into a blood vessel lumen to maintain a patency of a conduit and to balance flexibility and radial resistive force for delivery through a microcatheter. The device described herein are configured to transition from a crimped configuration to an expanded configuration. In the crimped configuration, a crimped diameter of the devices is less than about 0.7 mm. In the expanded configuration, the devices are configured to have an expansion diameter of greater than about 3 mm measured at the body section. The devices described herein are configured to have a radial resistive force greater than about 0.20 N/mm at 1 mm of compression in the expanded configuration. Various devices having these features are described herein.

Abstract: A vaginal dilation device is provided that may include any of a number of features. One feature of the vaginal dilation device is that it is configured to dilate vaginal tissue during labor to prevent tissue damage. Another feature of the vaginal dilation device is that it can be manually controlled to dilate vaginal tissue, or can be automatically controlled to dilate vaginal tissue. In some embodiments, the vaginal dilation device is configured to measure a force applied by the device to tissue. Methods associated with use of the vaginal dilation device are also provided.

Abstract: Devices for restricting flow in blood vessels, and methods of using said devices, the device comprising a first end; a second end; a first opening positioned at the first end, a size of the first opening adjustable from a first size to a second size; a second opening positioned at the second end, the second opening having a greater cross-sectional area than the first opening; and a plurality of struts extending from the first end toward the second end and defining the first opening and the second opening, the plurality of struts extending in a radially outward direction along a portion of their length, wherein the device is collapsible to enable percutaneous delivery.

Abstract: Devices, systems and methods for altering functioning of a tissue/organ by application of force thereto. In one preferred embodiment, a device for reducing or preventing regurgitation of blood through a valve of a heart is provided. A device may include a main body having a segment adapted to apply force to a surface of tissue/organ and a member that applies counterforce to the force applied by the segment. Kits are provided in which devices having varying lengths and widths can be selected for the best fit for a particular location of treatment. A width sizing instrument may be provided. A length sizing instrument may be provided. A separate sleeve and/or pad may be provided which may be first anchored to the tissue/organ before fixing the device thereto.

Abstract: A vaginal dilation device is provided that may include any of a number of features. One feature of the vaginal dilation device is that it is configured to dilate vaginal tissue during labor to prevent tissue damage. Another feature of the vaginal dilation device is that it can be manually controlled to dilate vaginal tissue, or can be automatically controlled to dilate vaginal tissue. In some embodiments, the vaginal dilation device is configured to measure a force applied by the device to tissue. In other embodiments, the vaginal dilation device is configured to apply a constant force to tissue. In other embodiments, the vaginal dilation device is configured to expand at a constant rate. Methods associated with use of the vaginal dilation device are also provided.

Abstract: Systems for the treatment and prevention of pelvic dysfunction are provided. In one embodiment, a vaginal dilation device includes a handle portion and a shaft portion. The shaft portion is configured to expand from a collapsed configuration to an expanded configuration. The shaft portion can include a distal tip region, a spine region, and a distal arm region connecting the distal tip region to the spine region. The spine region can extend distally from the handle portion to the distal arm region, and can be generally tubular in shape. The distal arm region can be generally conical in shape and be configured to provide a gradual increase in diameter from the distal tip region to the spine region. Methods of use are also provided.

Abstract: A vaginal dilation device is provided that may include any of a number of features. One feature of the vaginal dilation device is that it is configured to dilate vaginal tissue during labor to prevent tissue damage. Another feature of the vaginal dilation device is that it can be manually controlled to dilate vaginal tissue, or can be automatically controlled to dilate vaginal tissue. In some embodiments, the vaginal dilation device is configured to measure a force applied by the device to tissue. In other embodiments, the vaginal dilation device is configured to apply a constant force to tissue. In other embodiments, the vaginal dilation device is configured to expand at a constant rate. Methods associated with use of the vaginal dilation device are also provided.

Abstract: Systems for the treatment and prevention of pelvic dysfunction are provided. In one embodiment, a vaginal dilation device includes a handle portion and a shaft portion. The shaft portion is configured to expand from a collapsed configuration to an expanded configuration. The shaft portion can include a distal tip region, a spine region, and a distal arm region connecting the distal tip region to the spine region. The spine region can extend distally from the handle portion to the distal arm region, and can be generally tubular in shape. The distal arm region can be generally conical in shape and be configured to provide a gradual increase in diameter from the distal tip region to the spine region. Methods of use are also provided.

Abstract: A vaginal dilation device is provided that may include any of a number of features. One feature of the vaginal dilation device is that it is configured to dilate vaginal tissue during labor to prevent tissue damage. Another feature of the vaginal dilation device is that it can be manually controlled to dilate vaginal tissue, or can be automatically controlled to dilate vaginal tissue. In some embodiments, the vaginal dilation device is configured to measure a force applied by the device to tissue. In other embodiments, the vaginal dilation device is configured to apply a constant force to tissue. In other embodiments, the vaginal dilation device is configured to expand at a constant rate. Methods associated with use of the vaginal dilation device are also provided.

Abstract: Systems for the treatment and prevention of pelvic dysfunction are provided. In one embodiment, a vaginal dilation device includes a handle portion and a shaft portion. The shaft portion is configured to expand from a collapsed configuration to an expanded configuration. The shaft portion can include a distal tip region, a spine region, and a distal arm region connecting the distal tip region to the spine region. The spine region can extend distally from the handle portion to the distal arm region, and can be generally tubular in shape. The distal arm region can be generally conical in shape and be configured to provide a gradual increase in diameter from the distal tip region to the spine region. Methods of use are also provided.

Abstract: Devices, systems and methods for altering functioning of a tissue/organ by application of force thereto. In one preferred embodiment, a device for reducing or preventing regurgitation of blood through a valve of a heart is provided. A device may include a main body having a segment adapted to apply force to a surface of tissue/organ and a member that applies counterforce to the force applied by the segment. Kits are provided in which devices having varying lengths and widths can be selected for the best fit for a particular location of treatment. A width sizing instrument may be provided. A length sizing instrument may be provided. A separate sleeve and/or pad may be provided which may be first anchored to the tissue/organ before fixing the device thereto.

Abstract: Systems for the treatment and prevention of pelvic dysfunction are provided. In one embodiment, a vaginal dilation device includes a handle portion and a shaft portion. The shaft portion is configured to expand from a collapsed configuration to an expanded configuration. The shaft portion can include a distal tip region, a spine region, and a distal arm region connecting the distal tip region to the spine region. The spine region can extend distally from the handle portion to the distal arm region, and can be generally tubular in shape. The distal arm region can be generally conical in shape and be configured to provide a gradual increase in diameter from the distal tip region to the spine region. Methods of use are also provided.

Abstract: Systems for the treatment and prevention of pelvic dysfunction are provided. In one embodiment, a vaginal dilation device includes a handle portion and a shaft portion. The shaft portion is configured to expand from a collapsed configuration to an expanded configuration. The shaft portion can comprise a distal tip region, a spine region, and a distal arm region connecting the distal tip region to the spine region. The spine region can extend distally from the handle portion to the distal arm region, and can be generally tubular in shape. The distal arm region can be generally conical in shape and be configured to provide a gradual increase in diameter from the distal tip region to the spine region. Methods of use are also provided.

Abstract: A vaginal dilation device is provided that may include any of a number of features. One feature of the vaginal dilation device is that it is configured to dilate vaginal tissue during labor to prevent tissue damage. Another feature of the vaginal dilation device is that it can be manually controlled to dilate vaginal tissue, or can be automatically controlled to dilate vaginal tissue. In some embodiments, the vaginal dilation device is configured to measure a force applied by the device to tissue. In other embodiments, the vaginal dilation device is configured to apply a constant force to tissue. In other embodiments, the vaginal dilation device is configured to expand at a constant rate. Methods associated with use of the vaginal dilation device are also provided.

Abstract: A vaginal dilation device is provided that may include any of a number of features. One feature of the vaginal dilation device is that it is configured to dilate vaginal tissue during labor to prevent tissue damage. Another feature of the vaginal dilation device is that it can be manually controlled to dilate vaginal tissue, or can be automatically controlled to dilate vaginal tissue. In some embodiments, the vaginal dilation device is configured to measure a force applied by the device to tissue. In other embodiments, the vaginal dilation device is configured to apply a constant force to tissue. In other embodiments, the vaginal dilation device is configured to expand at a constant rate. Methods associated with use of the vaginal dilation device are also provided.