Abstract:
A multiple dose syringe has a first valve defining a first valve opening pressure and a second valve defining a second valve opening pressure. A storage chamber in fluid communication with the second valve stores multiple doses of a substance therein and includes an outlet for dispensing multiple doses of the stored substance therethrough. A compression surface is movable between first and second positions and defines a compression chamber between the compression surface and the first valve. Movement of the compression surface in a direction from the first position toward the second position dispenses substance in the compression chamber through the first valve and out of the syringe. Movement of the compression surface in a direction from the second position toward the first position causes substance to flow from the storage chamber through the second valve and into the compression chamber.
Abstract:
An injection member penetrates an elastic septum of a device defining a sealed, empty, sterile chamber in fluid communication with the septum. During penetrating, an annular interface is formed between the septum and the injection member extending axially between a penetration point on an interior surface of the septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member. The injection member is de-contaminated by (i) friction between the septum and injection member at the annular interface, and (ii) elongation of the septum at the annular interface. A substance is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.
Abstract:
An aseptic fluid connector having a male connector and a female connector engageable to aseptically transfer fluid therethrough. The male connector includes a closure and a piercing member comprising a hollow shaft for receiving fluid therein, a tip, and at least one port in fluid communication with the interior of the hollow shaft for passage of the fluid therethrough. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s). The female connector includes a pierceable septum. The male and female connector are engageable such that the piercing member pierces the pierceable septum. Only when the pierceable member has fully penetrated the pierceable septum can the closure and/or the shaft move from the first position, to the second position to aseptically transfer fluid therethrough.
Abstract:
A vial for storing multiple doses of a substance to be dispensed into one or more syringes or other delivery devices. The vial has a body, a storage chamber within the body for storing multiple doses of the substance therein, a sterile filter configured to sterilize air or other gas flowing into the storage chamber through the filter, and a one-way valve connectable in fluid communication with a syringe or other delivery device. The one-way valve is moveable relative to the body between first and second positions (i) one of which permits the valve to open so that substance from the storage chamber can flow therethrough and into the syringe or other delivery device connected in fluid communication therewith, and (ii) one of which prevents the valve from opening.
Abstract:
An aseptic fluid connector having a first connector including a first fluid passageway for receiving a fluid therein; a first port in fluid communication with the first fluid passageway for passage of the fluid therethrough; and a first deflecting member. The first deflecting member includes a first engaging portion radially spaced relative to the first port, and a first valve movable between a closed position and an open position with movement of the first engaging portion between a non-deflected position and a deflected position, respectively. In the non-deflected position, the first valve is located in the closed position forming a fluid-tight seal between the first valve and first port and preventing the passage of fluid therethrough, and in the deflected position, the first valve is located in the open position allowing the aseptic passage of fluid through the first port.
Abstract:
An injection member penetrates an elastic septum of a device defining a sealed, empty, sterile chamber in fluid communication with the septum. During penetrating, an annular interface is formed between the septum and the injection member extending axially between a penetration point on an interior surface of the septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member. The injection member is de-contaminated by (i) friction between the septum and injection member at the annular interface, and (ii) elongation of the septum at the annular interface. A substance is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.
Abstract:
A device that has a device body defining an opening at one end thereof, a storage chamber within the device body for storing multiple doses of a substance therein, and a sliding stopper, sealing engageable with the device body, through which the chamber is filled. The stopper has a body and a flexible portion, which may be in the form of a plurality of flexible members, extending therefrom. The flexible portion or members are movable between first and second positions. In the first position, during filling, the portion or members are substantially laterally extending from the stopper body and engaging the opening of the device body. Accordingly, the axial position of the stopper with respect to the device body is secured during filling of the chamber therethrough. In the second position, after filling, the portion or members are substantially axially-extending from the stopper body and disengaged from the rim or opening of the device body. Accordingly, the stopper is axially slideable through the body.
Abstract:
A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other.
Abstract:
A device includes a first part having a co-molded first support, valve cover and elastic actuator, and a second part having an injection molded second support, valve seat, and variable-volume storage chamber pre-form. The pre-form is blow molded into a flexible pouch defining the variable-volume storage chamber. The one-way valve includes a semi-annular, curvilinear, relatively rigid valve seat defining axially-extending, opposing first marginal portions, and an axially-extending first mid-portion angularly extending between the opposing first marginal portions. A flexible valve member is superimposed on the valve seat and defines axially-extending, opposing second marginal portions fixedly secured on or adjacent to respective first marginal portions of the valve seat, and an axially-extending second mid-portion angularly extending between the opposing first marginal portions and superimposed onto the first mid-portion of the valve seat. The flexible valve cover and valve seat form a normally closed axially and angularly extending valve seam therebetween.
Abstract:
An apparatus and method for sterile filling comprises de-contaminating a needle penetrable surface of a device including a needle penetrable septum and a sealed chamber in fluid communication with the needle penetrable septum. A filling needle penetrates the needle penetrable septum, introduces substance through the filling needle and into the chamber and is, in turn, withdrawn from the septum. A liquid sealant is applied to the penetrated region of the septum. Radiation or energy is applied to the liquid sealant to cure the liquid sealant from a liquid phase to a solid phase.