摘要:
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. When the syringe components are manufactured at different locations, each component is tripled-bagged to maintain the component substantially free from contaminants, and transported to an assembly site where the components are unpackaged and assembled into the barrel/tip seal combination and plunger. When filling and final assembly of the barrel/tip seal combination takes place at a location separate from its assembly site, the barrel/tip seal combination is tripled-bagged to maintain it substantially free from contaminants, and transported to a filling and final assembling site for filling and final assembling into a prefilled syringe.
摘要:
Systems, devices, and methods towards improved diagnosis and therapy in connection with central venous catheters (including PICC lines). Included among the many improvements broadly contemplated herein are: arrangements via which a venous catheter can move passively into position in central venous circulation; arrangements via which a catheter can be actively guided without the use of a needle or guide wire; arrangements via which a catheter can be packaged to facilitate easy, rapid, and positionally accurate deployment by medical personnel while maintaining device sterility; and arrangements via which a catheter tip can be imaged during and after insertion.
摘要:
A system for delivering a fluid comprising cells to tissue of a patient, includes: a least a first container for holding an injection fluid in which the agent is carried; a first powered drive in operative connection with the container, the first powered drive being operable to pressurize contents of the container; a control system in operative connection with the first powered drive and operative to control the first powered drive; a fluid path in fluid connection with the container, the fluid path including a patient interface adapted to deposit the cells within tissue of the patient; a sensor system; and a communication system in connection with at least the control system and the sensor system. The communication system is adapted to provide information to the control system. The control system in adapted to transmit a control signal to at least the first powered drive based at least in part on information provided to the control system. The cells can for example be pregenitor cells or stem cells.
摘要:
A method and device for the simultaneous or sequential introduction of multiple fluids into the bloodstream including a multiple lumen catheter with corresponding multiple hole sets. By introducing a second fluid such as saline, the concentration and bolus of a first fluid, such as a contrast agent, can be controlled and optimized.
摘要:
A front-loading syringe which comprises a movable plunger for injecting liquid contrast media, is rotatably mountable on a front wall of an injector housing with an interference fit and in sealed relationship with respect thereto, with or without a pressure jacket, by a first-quick release mechanism. At the same time, the plunger is connected to an injector drive mechanism by a second readily releasable mechanism. During the mounting operation, a sensor reads injection information from an indicator device on the syringe and feeds it to an injector control. An audible-and-tactile indicating mechanism also is activated when the syringe is essentially in the desired mounted position. The syringe may include reinforcing ribs which also function as volumetric gradations, and liquid media presence-or-absence indicating dots which appear circular against a liquid media background and oval-shaped against an air background. An injection end of the syringe comprises an injector portion of reduced diameter inside a screw-threaded attachment portion of larger diameter, and may include loop-shaped reinforcing handle portions.
摘要:
A front-loading syringe which comprises a movable plunger for injecting liquid contrast media, is rotatably mountable on a front wall of an injector housing with an interference fit and in sealed relationship with respect thereto, with or without a pressure jacket, by a first-quick release mechanism. At the same time, the plunger is connected to an injector drive mechanism by a second readily releasable mechanism. During the mounting operation, a sensor reads injection information from an indicator device on the syringe and feeds it to an injector control. An audible-and-tactile indicating mechanism also is activated when the syringe is essentially in the desired mounted position. The syringe may include reinforcing ribs which also function as volumetric gradations, and liquid media presence-or-absence indicating dots which appear circular against a liquid media background and oval-shaped against an air background. An injection end of the syringe comprises an injector portion of reduced diameter inside a screw-threaded attachment portion of larger diameter, and may include loop-shaped reinforcing handle portions.
摘要:
A method and device for the simultaneous or sequential introduction of multiple fluids into the bloodstream including a multiple lumen catheter with corresponding multiple hole sets. By introducing a second fluid such as saline, the concentration and bolus of a first fluid, such as a contrast agent, can be controlled and optimized.
摘要:
An injector system includes a syringe and an injector. The syringe includes a body portion and a plunger movably disposed within the body portion. The injector includes a housing defining a front opening therein, a drive member extendible through the front opening of the housing for imparting motive force to the plunger disposed within the syringe, and a pressure jacket assembly associated with the housing for substantially enclosing the syringe during an injection procedure. The pressure jacket assembly includes a jacket cylinder having an open front end for receiving the syringe and a front member associated with the housing. The front member is pivotable between a closed position for retaining the syringe within the jacket cylinder and an open position for allowing the syringe to be inserted into and removed from the front end of the jacket cylinder.
摘要:
An injection apparatus for use with a syringe is provided. The injection apparatus includes an injector and a pressure jacket assembly. The injector preferably includes a housing defining a front opening and a drive piston extendible through the front opening for imparting motive force to a plunger disposed within the syringe. The pressure jacket assembly preferably includes a jacket cylinder having a rear end coupled to the injector housing and an open front end for receiving the syringe therethrough, a support member having a rear end pivotally coupled to the injector housing and a front end, and a front member pivotally coupled to the front end of the support member. Preferably, the front member is pivotable between a closed position for retaining the syringe within the jacket cylinder and an open position for allowing the syringe to be inserted into and removed from the front end of the jacket cylinder.
摘要:
A front-loading syringe which comprises a movable plunger for injecting liquid contrast media, is rotatably mountable on a front wall of an injector housing with an interference fit and in sealed relationship with respect thereto, with or without a pressure jacket, by a first-quick release mechanism. At the same time, the plunger is connected to an injector drive mechanism by a second readily releasable mechanism. During the mounting operation, a sensor reads injection information from an indicator device on the syringe and feeds it to an injector control. An audible-and-tactile indicating mechanism also is activated when the syringe is essentially in the desired mounted position. The syringe may include reinforcing ribs which also function as volumetric gradations, and liquid media presence-or-absence indicating dots which appear circular against a liquid media background and oval-shaped against an air background. An injection end of the syringe comprises an injector portion of reduced diameter inside a screw-threaded attachment portion of larger diameter, and may include loop-shaped reinforcing handle portions.