Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-03-14
2002-05-07
Sykes, Angela D. (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S212000, C222S094000
Reexamination Certificate
active
06383166
ABSTRACT:
FIELD OF THE INVENTION
The instant invention is directed to instrumentalities for therapeutic infusion. More specifically, the invention is directed to a plungerless syringe which is prefilled and delivers sterile fluid for therapeutic administration, and a method therefore.
BACKGROUND OF THE INVENTION
The following invention chronicles the ongoing evolution of applicant's further insights with respect to the following patents:
Farris
5,102,398
Issued April 7, 1992
Farris
5,370,626
Issued December 6, 1994
Farris, et al.
5,538,506
Issued July 23, 1996
While these three technologies enumerated immediately hereinabove provide excellent therapeutic benefits, all have been shown to be quite excellent in respect of treatment of air entrained within a fluid during the Blow/Fill/Seal process. All of these patents sequester air from the fluid and excise the air from the fluid within the plungerless syringe prior to administration to a patient.
An additional nuance involves the recognition that when these syringes dock with other related infusion apparatus, such as a needle or catheter, the area of interconnection between the needle and/or catheter involves communication between these two elements at an interface. It has been observed that although a friction-type coupling will have been effected, the potential for minuscule albeit discernible quanta of air exists at the juncture between the infusion apparatus and the plungerless syringe. Although minuscule, microscopic or visible inclusions of air may have no discernible effect with respect to the vast majority of recipients of the infusion, applicant has developed further structure and method that treats the presence of this visible minute amount of air. Moreover, even small bubbles can be dangerous in very young, old or ill patients. For example, please see the appended article
Principals and Practice of Intravenous Therapy
at pages 53, 55 (Little, Brown and Company—fourth ed. 1987).
SUMMARY OF THE INVENTION
One salient attribute of the instant invention involves its contemplation of the small amount of air that can be found between a syringe needle or catheter juncture and its docking with the pre-filled plungerless syringes set forth above. Accordingly, an air chamber, partially filled with liquid, is provided extending from a back wall of a plungerless syringe. When the syringe is oriented in a vertical position with the air chamber at a highest elevation, after it has been docked with either a syringe needle or catheter, by vibrating the plungerless syringe (perhaps when coupled with first squeezing some liquid from the air chamber drawing some liquid into the coupling), any minute amounts of air encountered at the coupling situs will encourage the “coupling” air to migrate upwardly through the liquid filled major body portion of the plungerless syringe and into the air chamber along with the other air that has been sequestered which offsets the effect of the Blow/Fill/Seal process.
OBJECTS OF THE INVENTION
Accordingly, it is a primary object of the present invention to provide a new and novel apparatus for the safe infusion of liquids.
A further object of the present invention is to provide an apparatus as set forth above and a method associated therewith for manipulation of the syringe.
A further object of the present invention is to provide devices and methods as characterized above which take into account any small visible amounts of air which may initially exist between a syringe needle or catheter and a plungerless syringe.
A further object of the present invention is to provide a device as characterized above which is economical to manufacture and extremely safe to use.
A further object of the present invention is to provide device as characterized above and a method associated therewith which sequesters air from the juncture between a syringe and catheter or needle and allows the air to migrate to other air previously sequestered which was introduced during the Blow/Fill/Seal process.
Viewed from the first vantage point it is an object of this invention to provide a prefilled plungerless syringe comprising, in combination: a body having a back wall, a fluid outlet in fluid communication with an interior of the body, and a gas trap disposed on the back wall at an opposite end of the body from the fluid outlet, whereby any air existing at an interface with an infusion connector adapted to be coupled to the fluid outlet is to be received in the gas trap.
Viewed from a second vantage point it is an object of this invention to provide a method for sequestering gas from therapeutic fluid in a plungerless syringe having an air trap remote from a fluid exit, the steps including: docking the syringe with an infusion device at the fluid exit, orienting the syringe so that the air trap is at a higher elevation than the fluid exit, urging any gas from the infusion device and the syringe into the air trap, and injecting the therapeutic fluid.
These and other objects will be made manifest when considering the following detailed specification when taken in conjunction with the appended drawing figures.
REFERENCES:
patent: 5102398 (1992-04-01), Farris
patent: 5370626 (1994-12-01), Farris
patent: 5509906 (1996-04-01), Poynter
patent: 5538506 (1996-07-01), Farris et al.
Principals and Practice of Intravenous Therapy, 1987, pp. 53 and 55, Little Brown and Company—Fourth ed.
Cove Zephyr
Kreten Bernhard
Stright Ronald
Sykes Angela D.
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