Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-01-20
2003-07-29
Hayes, Michael J. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S246000, C604S411000, C604S905000, C604S256000, C251S149100
Reexamination Certificate
active
06599273
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a device for transferring medication or another fluid from one location to another. This device eliminates the need for handling needles by medical personnel during the administration of medication.
2. Background Discussion
The manipulation of fluids for parenteral administration in hospital and medical settings routinely involves the use of syringes to facilitate the movement of a fluid between two points. Many syringes have needles attached which are used to pierce the seal or septum of a medicament container, or a septum in fluid communication with sterile tubing. Fluid then passes from the container or tubing into the syringe and is transferred from the syringe to an installed intravenous line (IV) or other fluid delivery system. Additionally, needles are often used to transfer fluids from one fluid line to another.
In some instances, the fluid is withdrawn from a single-dose medication container and injected into an IV system, supplementing the fluid already being administered through the IV line. These single-dose medication containers are then typically discarded. Commonly, these single-dose medication containers are “drip bags” for intravascular use, or vials bottles, or test tubes.
Intravenous tubing sets also commonly incorporate “y-connectors” having a septum which, when penetrated, allows access to the fluid flowing within the tubing set. Syringes are often used to penetrate the septums and add or withdraw fluid from the tubing set.
The sharp needles employed with conventional syringes used to draw or introduce fluid from containers or tubing sets introduce the risk of puncture wounds to the user or patient, with a concurrent risk of exposure to a direct dose of medication which can be, in extreme instances, fatal.
A medication transfer system that is easy to use and eliminates the threat posed by exposed needles would therefore be of great benefit to the medical community.
SUMMARY OF THE INVENTION
One embodiment of the present invention is a medication transfer device which eliminates the risk of accidental needle sticks during the handling of fluid-filled syringes having attached needles. As will be discussed in detail below, the device assists in the transfer of fluid from a sealed container to a syringe or vice versa.
The present invention comprises a piercing device used to access fluid in the interior of a vial through a pierceable seal located at the top of the vial, and facilitate the transfer of the fluid into a syringe. The device comprises a piercing element, having a hollow tube with an exterior surface, an interior bore, and at least one hole in the piercing element through which fluid flows into the interior bore of the piercing element. The device also comprises a locking structure projecting outward from the exterior surface of the piercing element. This locking structure permits penetration of the pierceable seal by the piercing element, but prohibits withdrawal of the piercing element back through the pierceable seal. A connecting portion adapted to connect the device to a syringe allows fluid from the interior of the vial to pass through the device and into the syringe. In a preferred embodiment, the device also comprises a stop which limits the extent of penetration of the piercing element into the interior of the vial. This stop may be a round disk, or a tab, located on the piercing element. Preferably, the locking structure is at least one barb, which extends at an angle away from the piercing element. The connecting portion preferably forms a substantially fluid-tight seal with the syringe.
In accordance with another aspect of the present invention, a method of accessing and transferring fluid inside a vial through a pierceable seal on the vial, using a syringe, is provided. The method comprises the steps of connecting the syringe to a device having a piercing element. This piercing element has a hollow tube having an exterior surface, an interior bore, a distal end and at least one hole proximal to the distal end. The piercing element also includes a locking structure projecting outward from the exterior surface of the piercing element. This locking structure permits penetration of the pierceable seal by the piercing element, but prohibits withdrawal of the piercing element back through the pierceable seal. The piercing element is used to pierce the seal on the vial, and is inserted into the vial until the hole proximal the distal end of the piercing element contacts the fluid inside the vial. The desired amount of fluid is withdrawn from the vial through the internal bore in the piercing element and into the syringe. The syringe is then separated from the piercing element, such that the locking structure on the piercing element prohibits the withdrawal of the piercing element through the pierceable seal. In a preferred embodiment, the syringe and the piercing element are connected before the piercing element is inserted into the vial. Alternatively, the piercing element can be inserted into the vial prior to connecting it to the syringe. The method of the present invention further comprises connecting a second syringe to the piercing element which remains in the vial, and repeating the withdrawing and separating steps to fill the second syringe. In a preferred embodiment, the syringe forms a substantially fluid-tight seal with the piercing element.
In yet another embodiment of the present invention, the piercing device is used in conjunction with a medical valve to provide a resealable fluid pathway between a vial and a syringe. In accordance with this embodiment, the valve preferably comprises a hollow housing having a spike with a seal mounted thereon located within the housing. A first end of the housing allows a syringe or other medical implement to access the seal, which may be pressed over the spike to allow fluid flow therethrough. A second end of the housing allows access to the end of said spike opposite said seal. Threads are preferably located within the second end of the housing for securing a medical connector to the free end of the spike.
In operation the piercing device described above is pressed through a seal on a vial. The connecting end of the piercing element is then connected to the free end of the spike. Threads are preferably located on the outside of the connecting end of the piercing element for locking engagement with the threads located on the housing.
A syringe may then be pressed against the seal on the other end of the valve. At that time fluid may be withdrawn from the vial through the piercing element and valve and into the syringe. This system advantageously allows disconnection of the syringe from the valve, at which time the seal reseals the spike of the medical valve, thereby sealing the passage to the vial and protecting the integrity of the fluid therein.
Another aspect of this invention is an adaptor for use with medicament containers such as a drip bag. The adaptor has a medical valve as described above, which may be removably attached by a locking mechanism to a second tubular body having a tubular spike. The spike is in fluid communication with the medicament container. Alternatively, the second body and valve may be formed integrally. In use, the valve is attached to the medicament container and then the tip of an ANSI standard connector, such as an IV set or syringe, is pressed into the valve, depressing the seal and exposing the spike within the valve. The large tubular spike on the second body is then used to penetrate the seal or septum of the medicament container, and fluid is withdrawn through the valve. The aspect of this invention related to an adaptor for use with medicament containers also relates to the following embodiments:
A medical valve adaptor for use with containers of fluid, said valve adaptor comprising:
a first body having proximal and distal ends, and a cavity therein;
a first spike located within said cavity and attached to said proximal end;
a seal located on said first spike;
one or more tabs c
Hayes Michael J.
ICU Medical Inc.
Knobbe Martens Olson & Bear LLP
Rodriguez Cris L.
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