Abstract: A voice prosthesis insertion device includes an elongated body having an aperture therein extending axially along the elongated body. The elongated body includes a ring member at one end that is supported by a pair of straps. The elongated body has at least one region that is increasing in cross section. The elongated body further having a collapsible portion defined by a pair of openings in the elongated body. A rod is disposed in the aperture of the elongated body and including a peg adapted to be inserted into an aperture of a tether of a voice prosthesis device. The collapsible portion of the elongated body is flexible to allow the collapsible portion to be longitudinally collapsed to expose the peg of the rod for easy engagement with the strap of the voice prosthesis and the collapsible portion is extendable from the collapsed position to extend over the peg.

Abstract: A twist to lock heat and moisture exchanging device includes a housing having a first opening that is adapted to open to a tracheostoma and a second opening that opens to ambient. A foam filter is disposed in the housing and a closure member is mounted to the housing and adapted to close a passage between the first opening and the second opening. A locking mechanism is engageable to prevent movement of the closure member to close the passage and disengageable to allow movement of the closure member to close the passage. The twist to lock tracheostoma heat and moisture exchanger allows a user to protect from accidental closure during activities when it would be preferred like sleeping and exercising.

Abstract: A handle assembly for controlling a steerable catheter includes a handle extending about a longitudinal axis from a proximal end to a distal end. A lumen extends through the handle to a distal tip extending outwardly from the distal end of the handle and a pair of control wires are interconnected to the distal end of extend the lumen. A lever assembly is disposed within the handle and includes a lever rotatable about a lever axis to control deflection of the distal end of the lumen. The lever assembly includes a first and second gear assembly disposed in opposing relationship to one another and offset relative to the longitudinal axis for allowing the lumen to pass therebetween. Each of the gear assemblies are interconnected to one of the pair of control wires to individually pull a respective one of the control wires in response to rotation of the lever.

Abstract: A medical valve assembly includes a tube extending between proximal and distal tube ends. A plunger plate extends radially from the distal tube end, and a valve housing surrounds the tube and extends between proximal and distal valve housing ends. The valve housing includes a flange extending radially inwardly from the distal valve housing end and disposed in spaced relationship with the plunger plate to define a distance dimension D extending therebetween. An elastomeric seal is compressed between the plunger plate and the flange to establish a closed condition of the medical valve assembly. The elastomeric seal axially moves one of the valve housing and the tube relative to the other when a medical device is inserted into the medical valve assembly to automatically increase the distance dimension and establish an open and sealed condition of the medical valve assembly with the inserted medical valve.

Abstract: An adjustable tracheostoma valve includes a housing having a first opening that is adapted to open to a tracheostoma and a second opening that opens to ambient. The housing includes a lower housing portion defining the first opening and an upper housing portion movably attached to the lower housing portion and defining the second opening. A closure member is disposed in the housing and adapted to close the second opening. A flexible membrane includes a first region connected to the closure member and a plurality of spiral shaped legs extending from the first region and connected to the housing. The upper and lower housings are axially adjustable relative to one another to adjust an amount of air flow through the valve that would cause closure of the closure member. A heat and moisture exchanger is disposed in the housing between the first opening and the second opening.

Abstract: An expandable introducer assembly for use in inserting a medical device into a body vessel of a patient includes an expandable sheath subassembly including a sheath hub and an expandable sheath extending from the sheath hub for initial insertion into the body vessel of the patient. The expandable introducer assembly also includes introducer subassembly including a hemostasis valve and an introducer sheath extending from the hemostasis valve and axial advanceable through the sheath hub and into the expandable sheath for radially expanding the body vessel. A coupler is releasably connected to the sheath hub and disposed in interlocked relationship with the hemostasis valve when the hemostasis valve is axially advanced with the introducer sheath towards the sheath hub for allowing serial retraction of the introducer sheath and the expandable sheath out of the body vessel of the patient.

Abstract: A modular handle assembly includes a dial rotatably connected to a handle and rotatable about a first rotary axis. A first gear arm extends from the dial and terminates at a first traction surface. A second gear arm is connected to the handle and rotatable about a second rotary axis that is parallel to the first rotary axis. The second gear arm terminates at a second gear tip that presents a second traction surface disposed against the first traction surface such that rotation of the dial in a first rotary direction effectuates rotation of the second gear arm in an opposite direction. A cam is coupled with at least one of the first and second gear tips and presents at least one deflection surface for deflecting a deflection wire during rotation of the dial to steer a distal end of a steerable catheter containing the deflection wire.

Abstract: A medical valve assembly includes a tube extending between a first and second tube end along an axis, and a plunger plate extends radially from the second tube end. A valve housing surrounds the tube and includes a radially inwardly extending flange. A compression member is biased against the plunger plate and compresses an elastomeric seal from a non-compressed condition to a compressed condition to establish a sealed condition of the medical valve assembly. An inner surface of the elastomeric seal in the non-compressed condition has a plurality of planar portions and a plurality of radiused portions, with adjacent planar portions interconnected with one of the radiused portions to improve a closure of the elastomeric seal during compression. The inner surface preferably includes three planar portions and three radiused portions to define a generally triangular-shaped inner surface as viewed in cross section in the non-compressed condition.

Abstract: An expandable introducer assembly includes a dilator subassembly extending from a proximal end to a distal end. The dilator subassembly includes a dilator having an insertion portion disposed adjacent the distal end, an expansion portion disposed adjacent the distal end, and a tapered transition portion disposed between the insertion and expansion portions. The dilator subassembly includes a distal sheath disposed in overlaying relationship with the insertion portion of the dilator. An introducer subassembly is disposed in coaxial relationship with the expansion portion of the dilator, and includes a valve disposed adjacent the proximal end and an introducer sheath extending from the valve in overlaying relationship with the expansion portion of the dilator.

Abstract: A modular handle assembly for supporting and controlling a steerable catheter having at least one deflection wire includes a handle portion which extends along an axis for being secured about a portion of the steerable catheter. The modular handle assembly includes at least one barrel that is rotatably connected to the handle portion for rotation about said axis and at least one actuation screw shaft that is disposed within said handle portion and which extends through the barrel for connection with the deflection wire of the steerable catheter. At least one pinion gear is disposed radially between the actuation screw shaft and the barrel and is threadedly interconnected with the actuation screw shaft and the barrel for translating rotational movement of the barrel about the axis into axial movement of the actuation screw shaft to provide for movement of the deflection wire to curl the steerable catheter.

Abstract: An adjustable base plate for use with a tracheotomy stoma includes a flexible membrane and a base component having an accessory mounting portion disposed in a center of the flexible membrane and adapted to mount a tracheostoma accessory. The base plate defines a conically shaped region formed by a plurality of conforming members extending radially from the accessory mounting portion that are laterally spaced from one another and connected to one another by a plurality of web portions formed by the flexible membrane. An adhesive material is applied to the flexible membrane.

Abstract: A medical valve assembly includes a tube extending between a first tube end and a second tube end to define a passageway extending along a longitudinal axis between the ends. A plunger plate extends radially from the second tube end of the tube, and a valve housing surrounds the tube about the second tube end and extends from a first valve housing end to a second valve housing end. The valve housing includes a housing flange extending radially inwardly from the second valve housing end and disposed in spaced relationship with the plunger plate to define a distance dimension D extending therebetween. An elastomeric seal is compressed between the plunger plate and the housing flange, and one of the valve housing and the tube is axially movable relative to the other to vary the distance between said plunger plate and said housing flange and adjust an inner diameter of the elastomeric seal.

Abstract: A medical valve assembly includes a tube extending between proximal and distal tube ends. A plunger plate extends radially from the distal tube end, and a valve housing surrounds the tube and extends between proximal and distal valve housing ends. The valve housing includes a flange extending radially inwardly from the distal valve housing end and disposed in spaced relationship with the plunger plate to define a distance dimension D extending therebetween. An elastomeric seal is compressed between the plunger plate and the flange to establish a closed condition of the medical valve assembly. The elastomeric seal axially moves one of the valve housing and the tube relative to the other when a medical device is inserted into the medical valve assembly to automatically increase the distance dimension and establish an open and sealed condition of the medical valve assembly with the inserted medical valve.

Abstract: An expandable sheath assembly includes a support body extending from a proximal end to a distal end. A guide rod is interconnected to the support body and extends between the ends along an axis. A dilator extends from the guide rod for insertion into a body vessel, and a hub is releasable connected to the distal end of the support body. A distal sheath overlays the dilator, and a hemostatic valve is slidably disposed along the axis. A proximal sheath extends from the hemostatic valve and is disposed in surrounding and coaxial relationship with the guide rod. The proximal sheath is concurrently slidable with the hemostatic valve along axis to advance the proximal sheath through the hub and interleave the proximal sheath between the dilator and the distal sheath for lifting the distal sheath from the dilator and effectuating an expansion of the body vessel.

Abstract: An expandable introducer sheath for use in inserting a medical device into a body vessel of a patient includes a body which extends from a proximal end to a distal end along an axis. The body includes an inner layer, an outer layer, and an expandable reinforcement member which is disposed between said inner and outer layers. The expandable reinforcement member is configured to radially expand as the medical device is axially advanced or retracted through said introducer sheath. Once the medical device has exited the introducer sheath, the expandable reinforcement member facilitates a return of the introducer sheath to its original or unexpanded condition.

Abstract: A modular handle assembly for supporting and controlling a steerable catheter having at least one deflection wire includes a handle portion which extends along an axis for being secured about a portion of the steerable catheter. The modular handle assembly includes at least one barrel that is rotatably connected to the handle portion for rotation about said axis and at least one actuation screw shaft that is disposed within said handle portion and which extends through the barrel for connection with the deflection wire of the steerable catheter. At least one pinion gear is disposed radially between the actuation screw shaft and the barrel and is threadedly interconnected with the actuation screw shaft and the barrel for translating rotational movement of the barrel about the axis into axial movement of the actuation screw shaft to provide for movement of the deflection wire to curl the steerable catheter.

Abstract: A modular handle assembly for supporting and controlling a steerable catheter having at least one deflection wires includes a handle extending along an axis for being secured about a portion of the steerable catheter. The modular handle assembly includes at least one barrel rotatably connected to the handle for rotation about the axis, and at least one spindle disposed in and connected with said barrel for rotation about the axis with the barrel. At least one guide cable extends from an anchored end being anchored to the spindle to a distant end for connection with one of the deflection wires of the steerable catheter. The guide cable is wrapped about the spindle for axially moving the deflection wires in response to rotation of the first spindle about the axis by the barrel to curl the distal tip of the elongated body of the steerable catheter.

Abstract: A medical valve assembly includes a tube extending between a first tube end and a second tube end to define a passageway extending along a longitudinal axis between the ends. A plunger plate extends radially from the second tube end of the tube, and a valve housing surrounds the tube about the second tube end and extends from a first valve housing end to a second valve housing end. The valve housing includes a flange extending radially inwardly from the second valve housing end and disposed in spaced relationship with the plunger plate to define a distance dimension D extending therebetween. An elastomeric seal is compressed between the plunger plate and the flange, and one of the valve housing and the tube is axially movable relative to the other to vary the distance between said plunger plate and said flange and adjust an inner diameter of the elastomeric seal.

Abstract: A therapy device is provided for trismus prevention and treatment, and includes a first arm hingedly connected to a second arm, and a spring device disposed therebetween to press the first and second arms apart. A pair of bite pads are provided at the ends of each of the first and second arms and are designed to be engaged by a user's teeth or gums in order to bite down on the device to exercise the user's jaw, and more specifically, the muscles of mastication.