Abstract: A medical device for the treatment and irrigation of a sinus opening is described. The device allows for single-handed operation to access, dilate and irrigate a sinus opening. The device includes a sinus guide catheter, a guiding element, a balloon dilation catheter, a balloon catheter movement mechanism and a guiding element movement mechanism. A method for treating a sinus opening and irrigating a sinus is also described.

Abstract: A sub-assembly of a medicament delivery device, the sub-assembly including a housing for containing a propellant source, and a locking ring for attachment to the housing. The housing is configured to receive a flange of a syringe, the locking ring is configured to retain a syringe flange received in the housing between the locking ring and the housing when the locking ring is attached to the housing.

Abstract: The present invention relates to a shell assembly for a medicament delivery device, which shell assembly comprises at least one first shell section provided with an entry passage and designed such that at least a major part of a medicament delivery device entered through said entry passage is accommodated inside said at least one first shell section, a closure element operably arranged to said at least one first shell section for closing said entry passage, and fixation elements arranged for fixating said medicament delivery device in relation to said at least one first shell section and said closure element.

Abstract: In a general aspect, a syringe terminates the dispensing of a fluid based on a force applied to a plunger member of the syringe. In some aspects, a plunger member of a syringe includes a top portion, a bottom portion, and a contact portion. The top and bottom portions are in contact with the contact portion, and the bottom portion has a length greater than or equal to a length of the top portion. The contact portion permits the top portion to move independent of the bottom portion in response to a stress in the contact portion exceeding a critical stress. The stress in the contact portion is based on a first force applied to the top portion and a second force opposite the first force applied to the bottom portion.

Abstract: A dilation catheter system includes a body, a guidewire, and a dilation catheter having an elongate shaft. The dilation catheter system may include a locking mechanism to prevent the guidewire from moving relative to the elongate shaft or to lock the guidewire to the dilation catheter to form a fixed wire unit. The dilation catheter system may include a stabilizing tube extending from an actuator, to provide rigidity to the guidewire. The dilation catheter may include a grip element having a plurality of grip features disposed thereon. The dilation catheter may include a cap biased toward a first longitudinal position and movable to a second longitudinal position. A guide catheter secured to the cap is prevented from changing angular orientation in the first longitudinal position and is free to change angular orientation in the second longitudinal position.

Abstract: An intranasal occlusion device having an inflatable balloon within a sponge that is used to prevent drainage of fluid, such as blood and other fluids into the airway during sinus and nasal minor procedures or surgeries, and methods of using the device to occlude an intranasal cavity of a patient. The device provides for suction to remove the fluid and may facilitate office-based minor procedures or surgeries.

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: Various embodiments provide a device comprising a balloon assembly including a balloon, a film template, and a rigid element. The film template may have a fixed upper distension limit and may include at least one aperture. The rigid element may lay substantially flush with an outer surface of the balloon at a first inflated state of the balloon. The first upper distension limit of the balloon may be greater than the fixed upper distension limit of the film template and the balloon may outwardly protrude through the at least one aperture at a second inflated state. The rigid element may be extended in a radial direction away from the outer surface of the balloon as the balloon outwardly protrudes through the at least one aperture relative to the outer surface of the film template.

Abstract: A reservoir for liquid medicament includes a first boundary portion and a second boundary portion forming at least one cavity to receive the medicament. The first boundary portion is flexible, while the second boundary portion is rigid. At least one of the first and second boundary portions is a transparent boundary portion covered by an opaque cover which is at least partially detachable from the transparent boundary portion.

Abstract: A closed loop catheter useable for heat exchange is manufactured by forming a plurality of generally transverse bore holes though a flexible, multilumen catheter body, lacing a tube trough the bore holes so that loops of the tube protrude from the catheter body, connecting one end of the tube to an inflow lumen of the catheter and connecting the other end of the tube to an outflow lumen of the catheter. A heated or cooled heat exchange medium may then be circulated through the tube while the catheter is inserted in the vasculature of a subject, thereby resulting in heat exchange between the subject's flowing blood and the heat exchange medium being circulated through the tube.

Abstract: 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.

Abstract: An obturator provides access to a joint through a capsule surrounding the joint. A distal end of the obturator has a first distal location with a first width dimension and a second distal location with a second width dimension, wherein the second distal location is proximal to the first distal location and the second width dimension greater than the first width dimension. A retractable blade can extend from the obturator to be exposed between the first distal location and the second distal location.

Abstract: A fluid injection system that includes an injector head having a syringe for delivering a fluid to a patient; a mounting structure pivotally connected to the injector head and configured to support the injector head above a surface; and a control system operationally coupled to the injector head for controlling an injection procedure is disclosed. The fluid injection system is provided with various sensors to control various aspects of the fluid injection system, such as the establishment of a reference plane, the determination of a tilt angle of the injector head, and the determination of a temperature of an actuation system of the injector head.

Abstract: A surgical access assembly and method of use is disclosed. The surgical access assembly comprises an outer sheath and an obturator. The outer sheath and obturator are configured to be delivered to an area of interest within the brain. Either the outer sheath or the obturator may be configured to operate with a navigational system to track the location of either device within the brain.

Abstract: A system (5, 405) for infusing medication into a subject is provided. The system (5, 405) includes an injection system (50, 450) for controlling fluid flow from a fluid reservoir to a needle. A sensor (20) detects a characteristic indicative of fluid pressure in the needle. The injection system (50, 450) controls the flow of fluid to the needle in response to the characteristic detected by the sensor (20), which continuously detects the characteristic as the needle is inserted into the subject. The system may include a light assembly (100) connected with the injection system. The light assembly (100) may provide a continuously variable signal indicative of the fluid pressure in the needle. The system (5, 405) may further provide a mechanism that provides cues to the operator to insert the needle at a particular rate. The system may further include a conductive element (334) for providing electric nerve stimulation.

Abstract: A drug delivery device is provided having a housing, a lead screw that is rotatably fixed with respect to the housing during dose setting and during dose delivery and that is axially moveable in a delivery direction relative to the housing for dose delivery, a number sleeve threadedly engaged with the housing to be screwable relative to the housing, and a dial link which is axially moveable and rotatable with respect to the housing for dose setting and which is prevented from rotation with respect to the housing for dose delivery. The dial link is rotatably fixed with the number sleeve when the dial link and the number sleeve are in a first arrangement, and the number sleeve and the dial link are rotatable with respect to one another when the dial link and the number sleeve are in a second arrangement.

Abstract: A medical tube including a flexible tube-shaped main body, a hub connected to the proximal portion of the tube-shaped main body, and a strain relief member supported at a distal portion of the hub. The strain relief member surrounds a predetermined portion of the proximal portion of the tube-shaped main body. The tube-shaped main body includes a flexible portion which possesses increased flexibility for bending. The flexible portion includes at least one groove extending in a circumferential direction in the outer circumferential surface of the tube-shaped main body over a predetermined range in an axial direction of the tube-shaped main body from a position distal of the distal-most end of the strain relief member to a position proximal of the distal-most end of the strain relief member.

Abstract: The invention is a device for transmitting acoustical energy through the surface of the skin of a patient, coupled with the administration of a compound, for example an acne medication, for the purpose of temporarily expanding the patient's pore size and enhancing the delivery of the compound to the patient's pores. The ultrasonic transducer emits a sonic transmission of variable intensity and frequency for the purpose of enhancing the absorption of compounds that have first been deposited onto the surface of the skin and into skin pores that have been expanded by the ultrasound transmission.

Abstract: The invention is a single use delivery device configured to enable reconstitution of a lyophilized agent (e.g., vaccine, drug, medicament, etc.) stored within for subsequent delivery of the reconstituted fluid agent to a patient in a controlled manner and without requiring specialized skill in reconstituting the agent or administering delivery of such agent. The delivery device is prefilled with an individual dose of a lyophilized agent and configured to be filled on-site and in the field with a dose of diluent for reconstitution of the lyophilized agent, while remaining sterile and preventing the potential for contamination during the filling process. The delivery device is further configured to be rendered incapable of reuse followings its intended use of delivering the fluid agent to a patient, thereby preventing reuse of the device and reducing the risk of the spreading blood-borne diseases through reuse.

Abstract: A microneedle array is provided for administrating a drug or other substance into a biological tissue. The array includes a base substrate; a primary funnel portion extending from one side of the base substrate; and two or more solid microneedles extending from the primary funnel portion, wherein the two or more microneedles comprise the substance of interest. Methods for making an array of microneedles are also provided. The method may include providing a non-porous and gas-permeable mold having a two or more cavities each of which defines a microneedle; filling the cavities with a fluid material which includes a substance of interest and a liquid vehicle; drying the fluid material to remove at least a portion of the liquid vehicle and form a plurality of microneedles that include the substance of interest, wherein the filling is conducted with a pressure differential applied between opposed surfaces of the mold.