The present invention generally relates to medical connectors used in conducting fluids and more specifically to self-sealing male Luer connectors.
The self-sealing Luer connectors presently known and used in the art are generally designed to be connected to a patient's intravenous (“IV”) or gas sampling line, drug or solution source, or other medical device such that the connector's seal operates to trap all fluid on the side of the connector toward the patient in the case of an IV line or other device such as a fluid bag in the case of a fluid source. In the case of some connectors, the connector has an unsealed male Luer connector on one end that remains connected to the patient's IV line, fluid source or other device and a self-sealing female connector on the opposite free end of the connector through which a syringe or other such device may be engaged. In the case of other connectors, the connector does not have a separate male connector end but is instead a permanent part of the line or source.
In use, the syringe or other device having a male connector is connected to the female end of the connector to push or pull fluids through the connector, as when medications are dispensed within a patient's IV line. The syringe or other device is configured with a male Luer connector so as to engage the self-sealing female connector and cause the male Luer's central boss to contact the female Luer's seal membrane, opening the slit formed in the membrane and creating a fluid path through the connector. After the necessary fluids have been dispensed or withdrawn, the syringe is removed and the slit in the needle-free connector's seal membrane closes to reseal the female connector and trap all bodily fluids, including any just-dispensed medications, on the patient side of the connector.
Therefore, the bodily fluids are sealed off within the self-sealing Luer connector toward the patient and away from the care giver, preventing any escape of the fluids and protecting both the patient and the care giver from possible dangerous contamination. However, the free end of the syringe and any residual fluids remaining therein are unsealed and exposed. Rather than the self-sealing, needle-free connectors known in the art remaining attached to the syringe to trap any and all residual fluids within the syringe, they remain on the destination or source connector to trap all residual fluids there instead.
While these prior art self-sealing, needle-free Luer connectors generally adequately serve their intended purpose of providing a sealed, needle-free connection that remains on a patient interface or the like and allows for the connection of a syringe or other such device to dispense or extract fluids, it is clear that these connectors are not designed to remain on and seal off the syringe itself before and after use and are not used for such a purpose. Moreover, while this function is not necessarily required in the typical drug dispensing application, there are other applications in which the fluid being dispensed from or drawn into the syringe must itself be at all times sealed off and exposure to such fluid by a care giver or patient prevented or at least minimized. For this purpose, a different self-sealing, needle-free Luer connector design is necessary.
Specifically, in the area of nuclear medicine where radioactive isotopes are administered to patients, it is critical that exposure to the isotopes be minimized for the safety of both the care giver and the patient. Yet, with the existing connectors known and used in the art, the isotope may be sealed off while still in its vial or other container prior to administration and may be sealed off on the patient side by the typical self-sealing, needle-free connector after administration, as discussed above, but the syringe or other device used to transfer the isotope from its container to the patient during administration is unsealed and allows exposure to the isotope.
Similarly, in collecting blood from a patient, the typical blood collection device known and used in the art has on one end an unsealed male Luer connector for attaching to the conventional female Luer connector on a patient's IV line. On the device's opposite end there is configured a needle having a resilient sleeve and surrounded by an elongate tubular shield. In use, the blood collection device's male Luer connector is connected to the IV line's female Luer connector, which starts the flow of blood through the connectors and into the needle. The sleeve covering the needle prevents the unwanted escape of any blood until a vacuum blood collection tube is inserted into the blood collection device's tubular shield. The collection tube is formed at its free end with a rubber stopper or septum that, upon insertion into the shield, pushes back the resilient sleeve covering the needle while the needle itself penetrates the septum and enters the tube, allowing the flow of blood through the blood collection device and into the vacuum collection tube. When the desired quantity of blood has been collected, the collection tube is removed from the device, allowing the resilient sleeve to expand back over the needle in covering relationship and to, again, prevent the further flow of blood from the patient through the connectors. As such, the blood collection device remains connected to the IV line and thereby seals off any residual blood remaining therein.
However, it is likely that at some point it will be desirable to remove the blood collection device from the IV line female connector, as when medicines are to be administered through the connector as discussed above. In this case, because the male Luer connector end of the conventional blood collection device is not self-sealing, the residual blood within the device will then be exposed to the care giver and others at the male Luer end when the device is disconnected. Moreover, there are other blood collection applications known in the art in which it is desirable to be able to leave the vacuum collection tube connected to the blood collection device, or even have the collection tube permanently mounted in the device, in which case, after the required quantity of blood has been collected, the male Luer connector end of the blood collection device must be disconnected from the female Luer connector of the patient's IV line. Again, with the typical blood collection device, this presents a hazard to the care giver, as the collection device's male Luer is unsealed and disconnection may expose the care giver to blood remaining within the device.
Yet a further example is in the oncology area where certain drugs have great beneficial effect when confined to the circulatory system of a patient, yet are harmful to the skin or other tissue of a patient. Such drugs must be carefully controlled so that they do not reach tissues that may be harmed. Transferring such drugs from one container to another or to the patient's fluid line can be hazardous if seals are not present.
Hence, those skilled in the art have recognized a need for a self-sealing male connector that may be connected to a syringe or other such device or formed on a blood collection device to seal off residual fluids therein before and after connection to a female connector. The present invention fulfills this need and others.
USPTO Backgrounds
USPTO Backgrounds