Surgery – Container for blood or body treating material – or means used... – Bag type
Reexamination Certificate
2000-01-31
2002-12-10
Mendez, Manuel (Department: 3763)
Surgery
Container for blood or body treating material, or means used...
Bag type
Reexamination Certificate
active
06491679
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
A two-chambered receptacle for intravenous use is disclosed. Specifically, the subject receptacle comprises two pre-connected pouches linked by a connection tube that can be controlled to prevent mixing of the pouch components. More specifically, the two-chambered receptacle usually contains the components of a Total Parenteral Nutrition (TPN) solution. Usually, one pouch contains readily inactivated compounds such as lipids and the other pouch contains the remainder of the TPN solution.
2. Description of the Background Art
Complex solutions are often needed by patients undergoing varied types of medical treatments. Unfortunately, the components within the complex solutions often interact with one another when mixed. Thus, for reasons of chemical reactivity, neutralization, inactivation, precipitation, unwanted side-reactions, and the like, compartmented chemical, drug, and nutrient delivery containers need to exist and have existed for years. With these compartmented delivery systems, the components of the complex mixture are held in separate compartments, and the components are mixed immediately before usage by a patient.
Total Parenteral Nutrition (TPN) is one area in which complex mixtures of components are required. Typical components for a TPN solution are: fluids; carbohydrates; electrolytes; proteins; lipids; vitamins; and trace minerals. For diverse reasons, some patients can not be fed orally and require intravenous (IV) feeding. TPN supplies the nutrients needed by a particular patient. Usually, the nutrients are mixed by a pharmacy in a sterile IV container. Generally, the lipids should be separated from the bulk of the TPN solution until just prior to patient use. The subject invention permits such separation in an efficient, cost-effective, reliable, and easily-utilized form.
Various type of complex and costly medical solution bags have been presented in the previous literature. Most have numerous components that increase the expense of the product and augment the possibility of improper operation or wasted time in verifying that proper connections have been fashioned. One specific example of an existing two-chamber bag is one supplied by Baxter Laboratories (the All-In-One™). This bag is very similar to the one described in U.S. Pat. No. 4,458,811 referenced below, in that it contains two immediately adjacent chambers that are mixed by pulling away a “pull-tab” that separates the two chambers. Basically, a single bag is used with a rubber separator. Unfortunately, the type of arrangement with two immediately-related chambers has been found to leak during mixing and shipping (the rubber separator fails), a difficulty not found with the subject invention.
More specifically, U.S. Pat. No. 3,788,374 relates to a parenteral solution bag. Openings protrude from the perimeter of the bag for entering and exiting parenteral solution. A fused tearing tab is included with a protective closure for hermetically enclosing the protruding portion.
U.S. Pat. No. 4,198,972 discloses a blood and blood component storage bag having at least two hermetically-enclosed inlets at the top. Included is a burstable seal below at least one of the inlets.
Disclosed in U.S. Pat. No. 4,211,019 is an accommodative foot bed that has a resin storage bag that comprises two separated chambers with a jointly breakable connection. Upon breaking the connection, the resin components mix and enter a mixing chamber, thereby activating the resin for setting.
A platelet freezing bag is related in U.S. Pat. No. 4,365,629. Pull-apart seals protect as least two needle ports mounted in a flexible bag. An exit port is located near a push-apart seal formed in the body of the bag.
Described in U.S. Pat. No. 4,458,811 is a compartmented flexible solution container that has an elongated frangible member that separates the compartments. Breaking the elongated frangible member permits a user to mix the components kept within the compartments.
Presented in U.S. Pat. No. 4,507,114 is a multiple chamber container having a leak detection compartment. A leak detection pathway normally has no liquid within it, but upon leakage at the connection point between two compartments liquid appears in this leak detection pathway and a visual or similar detection system activated.
U.S. Pat. No. 4,608,043 describes an IV fluid storage and mixing system that has a two-compartment construction in which the two compartments are connected upon the application of force via a weakened section in a common wall. Once the weakened section ruptures, the solutions in each compartment encounter one another and mix when the bag is manipulated in a user's hand.
U.S. Pat. No. 4,661,100 discloses a urinary receptacle having a central bag for holding urine with least one internal container within the central bag that may be opened and the contents of the internal container mixed with the contents of the central bag.
Lastly, revealed in U.S. Pat. No. 5,394,907 is a device and method for dosing a liquid product. An enclosed bag has means for pinching off one or more compartments and means for introducing differing solutions into these pinched-off compartments. Upon removal of the pinching means, the solutions mix.
Each of the prior art inventions attempt to solve the problem of producing multi-chambered receptacles in ways that are not entirely satisfactory for IV use. For example, the prior art inventions often experience sealing problems that may cause or result in leaking between compartments. Other methods that incorporate mechanical separation do so in ways that are not entirely compatible with the size of IV equipment. In summary, there is a need in the art for improved multi-chambered IV receptacles.
The foregoing patents reflect the state of the art of which the applicant is aware, and are tendered with the view toward discharging applicant's acknowledged duty of candor in disclosing information which may be pertinent in the examination of this application. It is respectfully submitted, however, that none of these patents teach or render obvious, singly or when considered in combination, applicant's claimed invention.
SUMMARY OF THE INVENTION
An advantage of the present invention is to provide a liquid nutrient storage and delivery system that is leak-resistant and not subject to premature mixing of liquids contained within the system.
A further advantage of the present invention is to provide a method of utilizing a liquid nutrient storage and delivery system in a manner that minimizes leakage or inadvertent mixing of contained liquids.
Another advantage of the present invention is to disclose a liquid nutrient storage and delivery system that comprises relatively thin pouches that are approximately the same width as standard intravenous bags.
Yet another advantage of the present invention is to disclose a liquid nutrient storage and delivery system that contains two liquids that are stored separately from one another in the system prior to patient use, and allows for combining and mixing of the liquids prior to use.
An advantage of one embodiment of the present invention is to supply a liquid nutrient storage and delivery system that is leak-resistant and contains a connection tube that has a valve that permits mixing of two liquids only upon an irreversible breaking of a frangible member of the valve. As a further advantage, a liquid nutrient storage and delivery system is furnished that has two separate pouches connected by a valve-containing tube, thereby preventing leakage or mixing of liquids held within the pouches.
An advantage of a second embodiment of the present invention is to supply a liquid nutrient storage and delivery system that is leak-resistant and contains a connection tube with a clamp that permits mixing of the two liquids upon release of the clamp.
Yet a further advantage of the present invention is to provide a method of utilizing a liquid nutrient storage and delivery system in a manner that minimizes leakage or inadvertent mixing of contained liquid
Diamantidis Thomas G.
Okamoto Rodney
Coudert Brothers LLP
Mendez Manuel
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