Abstract: This invention relates to a process for manufacturing prefilled syringes where at least one of the syringe components is manufactured in at least a class 100 environment. The process includes the steps of manufacturing syringe components, such as the barrel and plunger substrate, within at least a class 100 and MCB-3 environment; manufacturing syringe components, such as the plunger cover and tip seal in an environment less clean than a class 100 environment; decontaminating the plunger cover and tip seal; lubricating at least one of the barrel, plunger substrate, plunger cover and tip seal; assembling the barrel and tip seal to form a barrel/tip seal combination; assembling the plunger cover and plunger substrate to form a plunger; filling the barrel/tip seal combination with a predetermined amount of fluid; and final assembling of the prefilled syringe by inserting the plunger into the barrel/tip seal combination.

Abstract: The plunger systems for use in an injector-actuated syringe of the present invention include a dynamic wedge seal which improves the sealing engagement between the plunger cover and syringe barrel, and flexible capture members extending from the rear surface of the plunger which permit the engagement and disengagement of the plunger from the injector drive means at any plunger position within the syringe. Further, the plunger systems include a contrast saving tip which expells the injection liquid from the syringe tip.

Abstract: The present invention provides a connection mechanism adapted to make a releasable connection between a syringe plunger and a drive member of an injector. The drive member is preferably movable in a generally reciprocal linear manner to control movement of the plunger within the syringe. The connection mechanism comprises at least one capture member attached to the plunger. The capture member forms a releasable connection with the drive member upon contact of the drive member during linear forward motion of the drive member when the capture member is rotated relative to the drive member to an engagement position. The capture member is further adapted to disconnect from the drive member upon rotation of the capture member relative to the drive member to a disengagement position.

Abstract: The present invention provides prefillable syringes and injectors for use therewith that expand and/or facilitate a variety of medical procedures involving the injection of a liquid medium. In several embodiments, the present syringes and injectors enable the use of current syringe materials at higher pressures than previously attainable or the use of other materials not previously usable with current high pressure-syringe and injector designs. In one embodiment, a syringe comprises an elongated cylindrical main body having a first pair and a second pair of mounting flanges encompassing collectively an arcuate length equal to at least approximately 180.degree. of the circumference of the rear portion of the cylindrical main body for releasably mounting the syringe in a desired position relative to the front wall of the injector housing.

Abstract: The plunger systems for use in an injector-actuated syringe of the present invention include a dynamic wedge seal which improves the sealing engagement between the plunger cover and syringe barrel, and flexible capture members extending from the rear surface of the plunger which permit the engagement and disengagement of the plunger from the injector drive means at any plunger position within the syringe. Further, the plunger systems include a contrast saving tip which expells the injection liquid from the syringe tip.

Abstract: An insertable intracavity probe for use in magnetic resonance imaging of an area of interest in a relatively inaccessible region of the body particularly the cervix is disclosed. The probe has an inflatable balloon structure with an internal pickup coil carried at the distal end of a shaft for rectal insertion of the coil and an inflatable anti-migration cuff to hold the probe in position and prevent outward migration thereof during a procedure. The balloon structure has an outer balloon shaped to facilitate insertion and accommodation of the coil to areas of the anatomy adjacent the cervix. Internally, the balloon structure has an inflatable balloon which can be used to adjust the shape of the coil to accommodate uniquely shaped anatomical areas.

Abstract: An insertable intracavity probe for use in magnetic resonance imaging of an area of interest in a relatively inaccessible region of the body is disclosed. The probe has an internal pickup coil carried at the distal end of a shaft for rectal insertion of the coil and an inflatable anti-migration cuff to hold the probe in position and prevent outward migration thereof during a procedure. The anti-migration cuff is carried on an outer sleeve which is slidably and rotatably mounted on the shaft. The coil is carried on a resilient tip structure at the distal end of the shaft which is flexible in the plane normal to the plane of the coil. Deflection of the coil assembly is controlled by a pair of control lines attached to the distal end of the tip structure. The lines may be selectively tensioned to deflect the coil in the direction of tension by a thumb wheel control at the handle of the probe.

Abstract: An insertable pickup probe and interface network for magnetic resonance imaging and spectroscopy. The pickup probe in the preferred embodiment is for use in imaging the male prostate and comprises an elongated shaft supporting a patient interface balloon at its distal end which contains a RF receiving coil. The interface balloon comprises an inflatable inner balloon enclosed by a flexible outer balloon. The receiving coil is positioned between the inner and outer balloons and placed intimately adjacent the region of interest by inflating the inner balloon to expand outwardly against the outer balloon. In addition, a non-stretchable planar material is provided on the surface on the inner balloon adjacent the receiving coil for ensuring that the receiving coil is placed adjacent the region of interest. The inner balloon is inflated by an inflator cuff connected to the shaft and communicated to the inner balloon by a first lumen in the shaft.

Abstract: An insertable pickup probe and interface network for magnetic resonance imaging and spectroscopy. The pickup probe in the preferred embodiment is for use in imaging the male prostate and comprises an elongated shaft supporting a patient interface balloon at its distal end which contains a RF receiving coil. The interface balloon comprises an inflatabe inner balloon enclosed by a flexible outer balloon. The receiving coil is positioned between the inner and outer balloons and placed intimately adjacent the region of interest by inflating the inner balloon to expand outwardly against the outer balloon. In addition, a non-stretchable planar material is provided on the surface on the inner balloon adjacent the receiving coil for ensuring that the receiving coil is placed adjacent the region of interest. The inner balloon is inflated by an inflator cuff connected to the shaft and communicated to the inner balloon by a first lumen in the shaft.

Abstract: An insertable intracavity probe for use in magnetic resonance imaging of an area of interest in a body cavity particularly the colon, has an elongate shaft with a handle at its proximal end and an inflatable balloon structure at its distal end. The balloon structure has an outer balloon containing a loop-type pickup coil for connection to an interfacing network. The coil is sandwiched between two internal separately inflatable balloons, and when the probe is inserted, the coil can be optimally positioned relative to the area of interest by controlled differential inflation of the balloons. The probe also has an insertable rod-like mandrel for providing twisting orbital-type movement of the balloon structure on the shaft, by rotation of the mandrel, useful to steer the probe along curves or bends in the body cavity when it is being inserted.

Abstract: A device for selectively providing precise incremental joint movement in a patient in either of two opposite directions with a tactile and audible feedback "click", includes first and second spaced disposable retractors for engaging respective parts of the patient adjacent the joint. One of the retractors is mounted on a fixed, inverted, U-shaped support member, and the other retractor is mounted on a movable actuating rod slidably mounted in the support member. The device is formed entirely of non-magnetic material and is readily operable by the patient, making the device especially useful in magnetic resonance imaging procedures. An operating mechanism for the actuating rod includes a pivoted operating handle having an integral drive pawl, and a retaining mechanism for the actuating rod includes a pair of resilient retaining or holding pawls pivoted on the support member adjacent opposite sides of the drive pawl.

Abstract: A device for providing precise incremental joint movement in a patient, includes first and second spaced retractors for engaging respective parts of the patient adjacent the joint. One of the retractors is mounted on a fixed support assembly and the other retractor is mounted on a movable actuation rod slidably mounted in the support assembly. The device is formed entirely on non-magnetic material and is readily operable by the patient, making the device especially useful in magnetic resonance imaging procedures. The retractors are of a construction such that they can be snapped onto the support assembly and the actuating rod, respectively, and then ruptured upon being removed therefrom, so as to prevent inadvertent use of the retractors on another patient.