Animal drug delivery device

Details Animal drug delivery device Animal drug delivery device

2000-03-24

2004-04-20

Hayes, Michael J. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S408000

Reexamination Certificate

active

06723076

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a collapsible apparatus for storing and dispensing fluids. More specifically, the invention relates to a pre-filled, portable, and collapsible bag for the storage and delivery of fluid medications, such as vitamins, vaccines, and nutrients to animals, that is designed to prevent contamination.
DESCRIPTION OF THE PRIOR ART
In administering parenteral medications such as vaccines, vitamins, and nutrients to animals, such as pigs and cattle, it is convenient to have a large reservoir of the medication to facilitate the rapid administration of the medication to many animals. The veterinarian or farmer (“user”) uses bottled materials since most of the materials are currently packaged in glass containers. Having obtained the bottled material, the user takes a long needle and inserts the needle into the bottle to extract a desired amount of material. This, however, results in contamination of the whole bottle. In addition, if the needle is introduced to manure or other contaminants, or the needle is not clean or sterile (typically it is not sterile), then the next time the needle is used there is a high possibility that Clostridium, Streptococcus or Staphylococcus could be introduced into the bottle. Clostridium, Streptococcus or Staphylococcus are just three of the common things (virus, contaminants, bacteria, fungi, etc.) in the environment that can be introduced into the bottle. Many other contaminants or diseases can be introduced into the bottle. Once these bacteria or contaminants are located in the bottle, they can grow and cause disease in the animal that was injected with the particular vaccine, vitamin or other material. Therefore, once the traditional bottle systems are opened and used, they will invariably begin to accumulate bacteria growth.
Another method utilizes a dispensing system similar to an IV bag. One disadvantage with the current IV bag systems is that it includes intricate fluid flow mechanisms which require discs and valves to properly regulate the flow of fluids. The high level of sophistication and large number of parts used to regulate the flow of fluid from the IV bags (dispensing systems) can also lead to increased maintenance problems when attempting to interface the systems with syringes or guns.
Another disadvantage is that these systems require the user to take and puncture the primary IV bag, bottle or other means (“material system”) with an object such as a syringe or IV simplex. The requirement to puncture a bag, for example, leads to the introduction of contaminants into the bag, thus destroying the sterility of the system.
Another conventional method involves the use of a rigid plastic container that serves as a reservoir to an animal dosing syringe or gun. Examples of dosing syringes and gun can be found in U.S. Pat. No. 4,020,838 to Phillips et al. and U.S. Pat. No. 4,816,741 to Cesaro. Such a container usually holds up to approximately three quarts of medication, which is usually poured into the plastic container and capped with a lid. The container is then connected to the dosing syringe or gun with plastic hosing through the lid of the container or the container itself. Many animals can then be treated with the same needle or dosing apparatus without having to refill the rigid plastic reservoir. Another example is U.S. Pat. No. 5,154,324 to Stratford, which discloses a portable dispensing system for administering fluids to livestock.
Unfortunately, there are many problems with the above-described devices, such as the conventional uses of a rigid plastic reservoir. One problem is that a vacuum is frequently formed in the container because it is typically airtight and the rigid plastic container does not collapse. As the medication is removed from the container, a vacuum is created and the syringe tends to draw air into the container because the passage through the needle constitutes the only vent in the system. As a result, the amount of medication to be administered can be adversely affected. More importantly, air and other contaminants may be inadvertently injected into the animal. Typically materials that are poured into the these containers are of reused medicaments and the like. This leads to undesirable sterilization problems.
A further problem with the use of rigid plastic containers is that they are frequently refilled and reused without proper cleaning. Often at the site at which the inoculation or treatment of the animals is taking place, there is little regard for or effort taken to ensure sanitation, prevent contamination, and promote cleanliness. After the last animal is treated, it is a common practice to leave any left-over medication in the containers until the next use. Thus, future uses of the container may be tainted with medications that have exceeded their shelf life, or if the container is being used to deliver a different medication, the remaining medication may contaminate the newly-added medication and adversely affect the treatment.
A further disadvantage with the use of reusable containers as a reservoir for the delivery of medications to animals is contamination in general. When the containers are refilled at the site of the treatment, impurities from the outside air may contaminate the medications while the container is being refilled. The contamination from outside air can also cause oxidation of the medication over time. This contamination may lead to a greater number of cysts and lesions found on the carcasses after slaughter and a significantly higher risk of injection abscesses and secondary infection, often resulting in death, impaired weight gain, and poor meat quality.
Although some medications are delivered to the user in a sterile form, the transition from the package to the container will compromise the sterility of the medication. Medications are packaged at the pharmaceutical companies in 100 cc-500 cc glass or plastic containers sealed with rubber stopper seals in quantities of usually ten to one hundred doses. At the farm, the user will transfer the medication from the package to the syringe, many times without the use of appropriate sterilization equipment or techniques. Consequently, the medications are easily contaminated by the outside air and non-sterile syringe parts, such as the needles used to pierce the rubber seal of the medication container, the contaminated syringe barrel, the seals at each end, and the plunger of the syringe.
Contamination also occurs during the refilling of the syringe as a contaminated needle is pierced through the rubber seal of the standard medication bottle and a charge of contaminated air is forced into the bottle to provide back pressure to refill the syringe. The user may reinsert the needle into the vaccine bottle five to ten times, for example, for refilling before the bottle is empty. It is not uncommon to vaccinate 100 or more animals with the same needle before switching to a clean needle. The more times the bottle is reentered and the longer the same needle is used, the greater the contamination to the product and to the animals being treated. In addition, cross contamination may occur due to the large number of times the same needle is used. The cross contamination will then cause the rapid spread of many other diseases within herds.
One animal that has been particularly prone to disease resulting from the aforementioned bacteria is the pig. A common parenteral treatment is the administration of iron dextran to pigs. It is well-known that pigs are born with a limited supply of iron (approximately 50 mg) and that a sow's milk contains an inadequate amount of iron (about 1 mg per day) to meet the continuing requirements (7-11 mg per day) of the rapidly growing piglet. The iron deficiency is caused by an imbalance between nutrient needs and availability. Deficiency occurs in nursing pigs due to minimal body stores at birth, low availability from colostrum and milk, confinement rearing and the animals' rapid growth. Without parenteral iron supplementation, signs of deficiency develop because

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