An introducer sheath assembly having a handle portion including a distal end and a proximal end, and an introducer sheath extending outwardly from the distal end of the handle portion, the introducer sheath including a device lumen configured to slidably receive a corresponding device, a guidewire lumen configured to slidably receive a corresponding guidewire, and at least one steering cable disposed within at least one steering cable lumens that are disposed radially outwardly from the device lumen, and the handle portion including at least one steering assembly for modifying the tension of at least one of the at least one steering cables.

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate shaft having a proximal end region and a distal end region. A first lumen may be defined in the shaft. A second lumen may be defined in the shaft. The distal end region may include a common lumen region in fluid communication with the first lumen and the second lumen. A deflectable member may be disposed within the shaft. The deflectable member may be designed to shift between a first configuration where the deflectable member directs a first medical device disposed within the common lumen region into the first lumen and a second configuration where the deflectable member allows a second medical device to move between the common lumen region and the second lumen.

The Cervical Dilator is an improved tool for dilating a woman’s cervix prior to gynecological surgeries. The Cervical Dilator comprises a solid dilator with a first diameter and a series of hollow dilators. The series of hollow dilators comprises a plurality of hollow dilators of increasing size. A first hollow dilator has a second diameter that may be 1 mm larger than the first diameter. A second hollow dilator has a third diameter that may be 1 mm larger than the second diameter. A third hollow dilator has a fourth diameter that may be 1 mm larger than the third diameter. Thereby, upon insertion of the next hollow dilator in the series, the dilation of the cervix is increases by 1 mm.

The Cervical Dilator is an improved tool for dilating a woman’s cervix prior to gynecological surgeries. The Cervical Dilator comprises a solid dilator with a first diameter and a series of hollow dilators. The series of hollow dilators comprises a plurality of hollow dilators of increasing size. A first hollow dilator has a second diameter that may be 1 mm larger than the first diameter. A second hollow dilator has a third diameter that may be 1 mm larger than the second diameter. A third hollow dilator has a fourth diameter that may be 1 mm larger than the third diameter. Thereby, upon insertion of the next hollow dilator in the series, the dilation of the cervix is increases by 1 mm.

Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

A splittable sheath includes a splittable sheath body, a splittable sheath hub, and a valve element. The sheath body comprises a generally flexible tubular structure, a proximal end, and a distal end. The sheath body defines a longitudinal axis and is splittable into two halves along a pre-determined line generally parallel to the longitudinal axis. The sheath hub extends from the proximal end of the sheath body and defines a longitudinal axis generally aligned with the longitudinal axis of the sheath body. The sheath body and sheath hub form an inner cavity along their respective longitudinal axes. The valve element includes a resilient plate and a sealing element. The resilient plate includes a distal portion extending radially inwardly from a side of the inner cavity. The sealing element includes a sealing surface and is supported by the resilient plate such that the sealing element is biased toward a position against a second sealing surface on at least one of the splittable sheath body and hub to substantially seal the inner cavity.

A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.

A cerebral vessel access device having a base tube comprising an inner lumen, a shapeable element disposed to one side of the base tube, and an outer jacket covering the base tube and a portion of the shapable element. The shapable element can be configured to deflect from an axis line causing the base tube and outer jacket to deflect along with the shapable element.

A vasculature navigation system may include a dilator having a proximal end and a distal end located opposite the proximal end, the dilator comprising a guidewire lumen extending between the proximal end and the distal end, the dilator defining a proximal portion and a distal portion located opposite the proximal portion. In some embodiments, the vasculature navigation system also includes an access port located at the proximal end of the dilator, a distal port located at the distal end of the dilator, and a hemostasis valve coupled to the proximal portion of the dilator. The hemostasis valve may be configured to control fluid flow between the proximal portion and the distal portion. In some embodiments, a flush port is coupled to the proximal portion of the dilator and located distal to the hemostasis valve, and the flush port is coupled to a fluid supply source.

This disclosure relates to methods and exemplary devices for making needle insertion safer and easier (NISE). This NISE device includes at small needle, cannula, and large needle in a nested assembly to provide less trauma to a target vessel during large needle insertion. The small needle is movable relative to a body of the device and within the cannula to a position exterior the cannula. The cannula is movable within the large needle to a position exterior to the large needle. In a preferred assembly, the cannula is provided with a dulled tip and successive cutting edges along a tapered shape from the narrow dulled tip to the cannula body, such that the cannula blunt tip prevents trauma during insertion while the successive cutting edges generally enlarge the opening for placement of the large needle. The device can be provided in a stand alone device or alternately integrated into existing off the shelf and currently available vascular devices.