Dispensing – Outlet element operated by pressure of contents – Spring form – resilient or compressible flow controller or...
Reexamination Certificate
2000-02-23
2001-03-20
Rivell, John (Department: 3753)
Dispensing
Outlet element operated by pressure of contents
Spring form, resilient or compressible flow controller or...
C222S546000, C137S859000
Reexamination Certificate
active
06202901
ABSTRACT:
BACKGROUND
The field of the invention relates generally to devices for delivering fluids having a broad range of viscosities, such as solutions, dispersions, suspensions, gels, pastes, powders such as talc, or other like materials.
In particular, the field of the invention relates to a modular cap delivery system for attachment to or integration into the neck of a container for multiple-dose, contamination-free delivery of flowable materials. A modular cap protects the constituent parts while providing for controlled, unidirectional, laminar flow to increase the rate of delivery over a wide range of applied pressures. At the same time, the modular cap system prevents backflow of matter into the flowable material within the container, thereby protecting the flowable material from contact contamination and from air and airborne contaminants. The flowable material within the container is also protected from contamination if immersed in concentrated suspensions of viruses, bacteria, molds or yeast. The system thereby maintains the sterility and integrity of a flowable material without the need for preservatives, antioxidants or other additives.
The dispensing of flowable materials in a contamination-free manner, especially over prolonged periods of time or in a repetitive manner, such as delivery of multiple doses, presents many difficulties. A major problem to be overcome concerns precise flow control and the prevention of backflow or reflux. External contaminants easily can enter a container through the backflow effect at the end of a delivery cycle.
Many fluids including viscous solutions are delivered through a collapsible or volumetrically reducible container that has a discharge port, such as a hole, nozzle, spout, or other type of opening. The contents of the container, such as a viscous paste, liquid, or other solution are delivered through the discharge port by internal pressure or by squeezing the container. Such a conventional method of dispensing a viscous material is imprecise and fails to prevent the entry of external contaminants into the container due to a backflow or reflux effect. That is, a conventional system for delivering a fluid typically allows air to replace the fluid that is expressed. In addition, as the volume of fluid in the container is reduced through successive delivery, flow becomes inaccurate, uneven and difficult to control. Such a conventional delivery system is highly undesirable when being used to administer a flowable material that needs to be closely controlled. In addition, if the discharge port is used in a contaminated environment, the entry of air, dust, filaments, airborne pathogens or microbes, quickly can damage the integrity of the contents of the fluid.
For example, many flowable materials are highly labile. Labile substances are difficult to preserve and break down quickly due to oxidation or hydrolysis. Many medications lose their effectiveness quickly when exposed to repeated influx of air or external contaminants in the course of regular use. In addition, many medications lose their effectiveness when combined with antimicrobial agents.
Thus, what is needed is a system for delivering a labile, flowable material, such as a medication, without danger of external contamination or loss of integrity due to exposure to air, dust, filaments, airborne pathogens, or antimicrobial agents. Such an improved delivery system would enhance the effectiveness of a labile medication, such as an ophthalmic solution, and would be capable of maintaining sterility throughout many uses over long periods of time. Such an improved delivery system also would effectively maintain the integrity of a fluid throughout its period of use and would extend the fluid's use life to that of its shelf life.
It has been found that the addition of some antimicrobial agents to labile medications not only can shorten overall use life and effectiveness, but also may produce deleterious side effects on a patient, such as delaying post-surgery healing rates. Conventional approaches to dispensing a flowable medium while alleging to prevent air, airborne pathogens or microbial contaminants from degrading the integrity of the flowable medium have not demonstrated they can do so, nor prevent viruses or bacteria from entering the dispensing container through contact or immersion. Therefore, it would be advantageous to develop a system for delivery of a flowable medication without contamination, even on direct contact with viruses or bacteria. Such a system would enable the medication to be delivered free of antimicrobial agents and therefore would achieve an enhanced therapeutic effect and a substantially prolonged use life.
It also would be advantageous to provide a system for delivery of a fluid, even a highly viscous material at an improved flow rate, such that the unit dosage delivered remained constant over time.
It also would be advantageous to provide an improved system for delivering a viscous material, such as a paste, gel, or other viscous substance, in a highly controlled, constant manner, irrespective of the change in volume of the volumetrically reducible container through repeated usage.
It also would be advantageous to provide a system for delivering a highly viscous material with a constant laminar flow and a simplified unidirectional flow path which could be completely cut off after each use, preventing the entrapment of material and providing a complete seal against contamination even by air or when in direct contact with microbes.
What is also needed is a system for delivering a fluid, such that a predetermined cracking pressure is achieved. The cracking pressure advantageously could be optimized for ease of flow and ease of use. Alternatively, it would be desirable if the cracking pressure also could be made higher, such as for impeding flow for safety considerations.
The foregoing and other disadvantages of conventional contamination-free delivery systems may be seen with reference to
FIGS. 1A-1D
. Referring to
FIG. 1A
, Gerber, U.S. Pat. No. 4,846,810 and Pardes, U.S. Pat. No. 5,092,855 disclose generally a valve or delivery system with central body core, delivery block or seat as shown. The arrows indicate the flow of a flowable material into and through the seat to its exit port. It is assumed that the container of flowable material is attached to the entrance port of the valve and flowable material passes through the valve in the path shown by the arrows. The container is not shown for the sake of simplicity. As is well understood by those skilled in the art, an enclosing sleeve (not shown) surrounds the valve body and constrains the flow of material in the direction shown by the arrows. The enclosing sleeve retains an elastomeric sheath or seal against the valve body, thereby providing a seal between the sheath and valve body. Note that this design produces generally a convoluted flow path having at least four changes of direction for the flowable material (please refer to FIG.
1
A).
In accordance with
FIG. 1A
, each delivery system or valve operates through two sets of ports within the valve body, thus rendering the flow path unnecessarily complex and unsuitable for viscous applications. For example, viscous material may become lodged or retained between the valve body and the enclosing sheath after use of the valve, thereby creating avenues for the entry of airborne pathogens. In addition, the complex flow path constrains the optimized delivery of a viscous material. In contrast, what is needed is a contamination-free delivery system which not only prevents contamination or degradation of the flowable material, but which also accelerates the flow rate of a viscous substance at low applied pressures.
Another conventional delivery system is shown in FIG.
1
B. Haviv, U.S. Pat. No. 5,080,138, discloses a valve assembly relying on a sleeve valve and consisting of multiple components. Backflow is prevented by a sheath which permits flowable material to flow out of the valve and attempts to prevent backflow into the container. This device is not
Deb Jyotirmay
Gerber Bernard R.
Rivell John
Waterfall Company, Inc.
Woodside Intellectual Property Law Group
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