Abstract: A vaginal speculum includes a frame and a first handle assembly pivotally mounted to the frame. The frame defines an opening between a first blade that is attachable to the frame and a second blade that is attachable to the frame opposite of the first blade, and a hinge assembly configured to flex the frame to selectively change a size of the opening. The first handle assembly includes a lever portion and a blade portion coupled to the lever portion. The blades have a proximal end attachable to the blade portion and a distal end portion spaced from the proximal end. When in a first collapsed insertion state, the hinge assembly collapses the frame and the first blade contacts the second blade. When in a second deployed state the hinge assembly expands the frame and the first blade is spaced apart from the second blade.

Abstract: A method of simultaneously collecting exocervical and endocervical cells from a female patient, includes providing a combination exo-endocervical sampling device including a sampler having a pair of opposing wings and a prominence extending from the wings. The opposing wings include a sampling surface and the prominence includes a multiplicity of endless looped fiber pairs distributed axially along a distal end section of the prominence. Each looped fiber pair includes a first loop extending transverse from the shaft and a second loop extending transverse from the shaft. The loops define a void space therebetween configured to capture exo-endocervical cells. The method includes placing the sampling device in contact with a cervix of the female patient, collecting exocervical cells with the opposing wings of the sampling device, and simultaneously collecting endocervical cells with the prominence.

Abstract: A combination exo-endocervical sampling device includes a shaft that includes a first end opposite a second end, and a combination exo-endocervical sampler configured to simultaneously collect endocervical cells and exocervical cells. The combination exo-endocervical sampler is coupled to the second end and includes a pair of opposing wings disposed transverse to the shaft and a brush extending from the wings along a central axis of the shaft. Each of the opposing wings includes a plurality of flexible loops configured to collect exocervical cells.

Abstract: A combination exo-endocervical sampling device includes a pair of opposing wings disposed transverse to a shaft, and a brush that extends from the wings along a central axis of the shaft. In this regard, each of the opposing wings includes a sampling surface having a staggered array of beads, and the brush includes a multiplicity of looped fibers, where each looped fiber includes a first closed end opposite a second closed end such that the closed ends extend transverse from the central axis of the shaft.

Abstract: A cap for a container is described that is configured to retain a gynecological sample collected with a sampling device. The cap includes a peripheral wall extending between a base and a flange opposite the base, and a diaphragm extending from the base of the peripheral wall. The flange projects beyond the peripheral wall and is configured to seat against a rim of the container. The diaphragm defines a first open area communicating with a second open area that is smaller than the first open area and includes a boundary spaced from the peripheral wall that is configured to detach the distally located sampler from the sampling device.

Abstract: A suture fixation system that is configured to secure a suture includes a pad and a suture fixation device configured to clamp and retain at least one end of a suture. The pad includes a suture surface opposite a tissue surface and defines an opening formed through the suture and tissue surfaces that is sized to provide a margin around a tissue lesion to be sutured. The suture is employed to stitch the tissue lesion closed, the suture having at least one free end that is held in place by the suture fixation device, and the pad configured to elevate a portion of the suture away from the tissue.

Abstract: An amniotomy device includes a shaft having a rupture crown disposed along a distal end portion of the shaft. The rupture crown includes a distal end defined by at least two leading bite wings and a recess formed in the distal end of the rupture crown between the leading bite wings. The leading bite wings are configured to engage amniotic membrane when the shaft is rotated and rupture the amniotic membrane.

Abstract: An amniotomy assembly includes an amniotomy device including a shaft having a rupture crown and a tubular sleeve disposed over at least a portion of the shaft and selectively lockable to the shaft. The rupture crown is disposed on a distal end portion of the shaft and includes a first set of leading bite wings formed on a distal end of the rupture crown and a second set of trailing bite wings formed on a side of the rupture crown adjacent to a side of the shaft. The tubular sleeve is movable relative to the rupture crown between a first position in which the rupture crown resides within the tubular sleeve and a second position in which the rupture crown extends from the tubular sleeve.

Abstract: A vaginal speculum includes a frame and a first handle assembly pivotally mounted to the frame. The frame defines an opening between a first blade that is attachable to the frame and a second blade that is attachable to the frame opposite of the first blade, and a hinge assembly configured to flex the frame to selectively change a size of the opening. The first handle assembly includes a lever portion and a blade portion coupled to the lever portion. The blades have a proximal end attachable to the blade portion and a distal end portion spaced from the proximal end. When in a first collapsed insertion state, the hinge assembly collapses the frame and the first blade contacts the second blade. When in a second deployed state the hinge assembly expands the frame and the first blade is spaced apart from the second blade.

Abstract: A disposable speculum blade cover includes a longitudinal body including a proximal end portion spaced from a distal end portion, where the body includes a first wall and an opposing second wall, and the first and second walls coupled to opposing sides of the body to define a pocket configured to receive a speculum blade. Each of the first and second walls extends along a longitudinal axis between the proximal end portion and the distal end portion, and the distal end portion curves away from the longitudinal axis to define a retention lip at a distal end of the cover.

Abstract: A sexually transmitted infection (STI) sampling device includes an elongated shaft that defines a first end separated from a second end, and an absorbent sampler coupled to one of the first and second ends. The absorbent sampler includes an absorbent core disposed on a longitudinal axis of the elongated shaft, and a plurality of fibers extending from the absorbent core. The plurality of fibers is configured to exfoliate and capture cells from a tissue surface of a patient, and the absorbent core is configured to absorb exfoliated cells not captured by the fibers.

Abstract: A combination exo-endocervical sampling device includes a pair of opposing wings disposed transverse to a shaft, and a brush that extends from the wings along a central axis of the shaft. In this regard, each of the opposing wings includes a sampling surface having a staggered array of beads, and the brush includes a multiplicity of looped fibers, where each looped fiber includes a first closed end opposite a second closed end such that the closed ends extend transverse from the central axis of the shaft.