Abstract:
A drug delivery device for holding sterile medicaments, vitamins, nutrients, and the like to animals. The delivery device comprises a flexible sealed bag having at least two attachment points which serve as openings for tubing, at least two flexible lengths of tubing connected to the attachment points of the bag at one end, and adapters attached to an opposite end of each tube wherein said adapters are complementary of one another and detachably connect thereto. A method of filling and using the drug delivery device is also contemplated by the present invention.

Description:
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&#39;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&#39; rapid growth. Without parenteral iron supplementation, signs of deficiency develop because of normal physiological utilization of this element. Thus, piglets need to be injected every 2 to 3 weeks with iron dextran supplements. With such frequent injections, it is important that the injections be accomplished efficiently and without introducing contaminants to the pigs. Moreover, when injecting baby pigs, one will usually only need one-third of the materials. Thus, a system which maintains the sterility of the materials during the use of the materials and the ability to store the remaining, unused materials in a sterile environment is provided. 
     From the foregoing discussion, it is apparent that there still remains a long-felt, but unfulfilled need to provide an acceptable device which allows a user to carry or transport sterile medicaments to the animals for injection. The fluid storage and dispensing apparatus of the present invention avoids the above-mentioned disadvantages which are characteristic of the prior art. 
     SUMMARY OF THE INVENTION 
     The fluid storage and dispensing apparatus of the present invention comprises a flexible, collapsible fluid storage and dispensing apparatus with multiple ports for filling and dispensing fluid to animals. The apparatus does not require the use of discs or valves in order to regulate the flow of fluid from the apparatus to the animal. The apparatus may be connected to a pistol grip syringe or syringe gun for the delivery of fluids to animals. 
     In addition, the pre-filled bag provides the user with a flexible, collapsible fluid storage and dispensing apparatus with multiple ports for filling and dispensing fluid to animals. 
     In the preferred embodiments of the present invention, the flexible, sturdy, collapsible fluid storage and dispensing apparatus comprises additional elements that facilitate the convenience, ease of operation and cleanliness of the apparatus. 
    
    
     Numerous objects, features and advantages of the present invention will be readily apparent to those of ordinary skill in the art upon a reading of the following disclosure when taken in conjunction with the accompanying drawings. 
     BRIEF DESCRIPTION OF THE DRAWING 
     FIG. 1 is a perspective view of the drug delivery bag, including the tubes and stopper which are interfaced with the drug delivery bag. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     With reference to FIG. 1 there is shown an animal drug delivery device or “bag system”  1 . The bag  2  is lightweight, collapsible and inexpensive. The sealed bag  2  is made of suitable material that is inert and biocompatible. The preferred material is plastic. More preferably, the material is composed of a thick vinyl material. One such plastic material is poly vinyl chloride, manufactured by the Plasco Co., in Chicago, Ill. The material is thicker than conventional vinyl bags so that it will substantially reduce the introduction of air into the bag  2 . 
     Another important feature of the bag  2  is the thick vinyl will hold up better in the field than typical IV bags that are being used today. For example, the thickness and strength of the bag  2  is such that a handle  3  is incorporated into the bag so that the bag  2  can attach to a cart or other holding device. 
     The thickness of the bag  2  can vary depending on the plastic material that is used. Typically, the thickness of the bag  2  will be between about 6 to about 12 mils. Preferably, the bag  2  has a thickness of about 6 mils. Additionally, the bag  2  will be colored to meet USP specifications so as to prevent light from penetrating the bag  2  and affecting the contents (i.e., fluid) within the bag  2 . The bag  2  will typically be opaque. 
     The bag  2  contains a first end  28  and at least one opening  20 , which is configured and dimensioned to receive a tube, such as filling tube  4 . The opening  20  is used for the passage of materials into and/or out of the bag  2 . The opening  20  can be formed in a multitude of ways. Typically, the opening  20  is formed during manufacture of the bag  2  by standard and well-known techniques (i.e., cutting out a portion of the bag, die cut, etc.). Preferably, filling tube  4  is used for transporting sterile fluid from a port or supply source of desired materials into the bag  2 . 
     Tube  4  has one end  10  connected to opening  20  of bag  2 . More preferably, the bag opening  20  is constructed such that it supports the attachment of the tube  4  to the bag  2 . This is accomplished by having a rigid like support  21  at the interface between the opening  20  and tube  4 . Preferably, support  21  is a thicker portion of the plastic material used to make bag  2 . By manufacturing bag  2  with thick supports  21  made of the same plastic material, an additional part that other bags in the art require is eliminated. When manufacturing the bag  2 , tubes ( 4 ,  5 , and  6 ) are typically heat sealed or solvent sealed to the bag  2 . This will cause tube  4  to be permanently fixed into the bag  2  itself. In the alternative, tube  4  is fixedly attached to bag  2  by known means in the art. Preferably, the support  21  is rigid enough to maintain the integrity of tube  4  in opening  20  so that tube  4  will not collapse or cinch in a manner that will constrict the flow of materials from the supply source to bag  2 . 
     At the opposite end  11  of tube  4 , there is a detachable complementary adapter  12  for sealing tube  4  from outside contaminants and/or connecting to one of the other tubes. The adapter  12  is such that it has a cap  14  to close adapter  12  from the outside. All the adapters will have a removable cap so as to close off the adapters and maintain the sterility of the system. 
     Preferably, detachable complementary adapter  12  is attached to tube  4  and will have a male or female part that can optionally interface with another detachable complementary adapter  13 . Adapters,  12  and  13 , are standard fittings which can be purchased from any number of suppliers. One common manufacturer of such adapters is Qosina. The adapters,  12  and  13 , are typically heat sealed to the particular tube. When the caps of the respective adapters  12  and  13  are removed, tubes  4  and  5  are open to the outside environment. This allows adapters  12  and  13  to communicate with one another so that there is a passageway for fluid flow into and out of them so that if desired, the fluid can run through the respective tube and adapter and into the adjacent adapter and tube. 
     In a preferred embodiment, the detachable complementary adapters  12  and  13  which when inserted into their respective tubes and closed with caps  14  and  24  will prevent air, fluids or other contaminants from entering the particular tube. Ideally, a preferred embodiment of the detachable complementary adapters  12  and  13  will include one adapter with a threaded female opening, while the other adapter will include a threaded male end such that the two adapters  12  and  13  can be connected with one another, via a screwing means. For example, adapter  12  will include a male end and adapter  13  will include a female end. The interface between the two adapters  12  and  13  is such that contamination of the bag  2  will be substantially eliminated. 
     Although it is possible to only have one opening with one tube attached, it is preferable that the bag  2  will include a second opening  22  which is also fitted with a rigid support  21  to secure and maintain the integrity of second tube  5  in opening  22 . The second tubing  5  has first end  23  connected to the bag  2  in opening  22 . At an opposite end  18  of tube  5 , there is an adapter  13  for communicating with complementary configured adapters. In addition, adapter  13  includes a cap  24  for closing and/or sealing the tube  5  from contaminants. Preferably, this adapter  13  has a fitting whose configuration is such that it can fixedly attach to the fitting of adapter  12 . A preferred embodiment of these adapters is a male/female configuration such that the adapters  12  and  13  can be detachably connected to one another by screwing them together. 
     By including adapters  12  and  13 , with connection means (i.e., threaded adapters), tubes  4  and  5  can be connected to one another when the bag  2  is or is not in use. In addition, the connection means allow the user to easily attach the delivery tube  5  to the automatic syringe system. 
     Similarly, the connecting means allow the user to quickly disconnect the syringe or gun from the bag system  1 . This provides a significant advantage over other devices, in that if the whole volume of material in the bag  2  is not used, the bag  2  can be placed back into a storage facility, such as a refrigerator. Moreover, the tubing  5  can quickly detach from the gun without having to detach the tubing  5  from the bag  2 . This also allows the user to maintain sterility in the bag system  1  because the fluid is only flowing in one direction, towards the gun or syringe. 
     A preferred embodiment of the bag system  1  includes a system where the material inside the bag  2  flows unidirectional out of the bag  2 , out to the adapter system (male and female adapters  12 ,  13 ) and then, into the gun or syringe itself. There are a large number of quality syringe guns on the market, for all injectables (i.e., medicaments) used with poultry, pigs, cattle, sheep, fish, etc. Generally, when using the syringe guns, the doses range from 0.1 ml to 10 ml. One common syringe is the Ovijector. Typically, these guns are one-way systems, where they automatically pull material one dose at a time up to the “injection” system. This embodiment results in a system without back flow. To further insure that there is no back flow, a clamp  16  can be utilized on the delivery tubing  5  that is connected to the injection system for the injection of the desired materials into the particular animal. The injection system is understood to mean the gun or syringe. 
     Furthermore, clamp  16  is used so that the injection system can be shut off before the injection system is disassembled. Accordingly, when the injection system (gun or syringe) is shut down (i.e., the gun is detached from the bag), clamp  16  will prevent any flow back into the bag  2 . This is one of the means for maintaining the sterility of the product in bag  2 . By closing off the bag system  1 , there is little or no opportunity for germs, dirt or other contaminants to travel into bag  2 . This is one of the many advantages of using a closed system. In the present invention, the user is able to maintain sterility of the product in bag  2  itself since there is no need to puncture the system. 
     This is particularly important because the present system allows the user to discontinue use of bag system  1  for a period of time and store bag system  1  until needed again. Once the material in bag  2  is needed again, the user can re-assemble the system  1  and use the stored material without compromising the sterility of the system  1 . This is a substantial advantage over other systems which are unable to remain sterile. This is particularly important when providing medicine such as vaccinations or vitamins to livestock. Typically when providing medicine to the livestock, the entire contents of the bag  2  are not used at one time. This is routine, for example, when providing iron dextran to baby pigs. Using a bag system  1  that allows the user to only use a portion of the contents is of particular concern for the users. Due to the conservation of materials by using these large bag systems, the user is able to reduce expenses and drastically cut down on the waste that is generally associated with the products currently on the market. Just as important, this invention prevents the contamination of the contents of the bag and this substantially reduces the incident of infection at the site of injection due to use of contaminated products. 
     Generally, when filling the bag  2  with a particular medicament or fluid, the desired fluid is automatically pumped from a storage container through filling tube  4  and into bag  2 . Alternatively, the desired fluid can be introduced into bag  2  by using a hand automated pump to control the flow of material through the filling tube  4  and into the bag  2 . Once the sterile fluid is delivered to the sterile bag  2 , tube  4  can be heat sealed or clamped so as to keep the contents of the bag  2  in a sterile environment. (See severing/sealing point  30 .) After the tube  4  is heat sealed, the remaining portion of tube  4  is severed at a position below the point in which the tube  4  is sealed. The severed section  29  is then attached to the gun or syringe and used as the connecting piece to a second tube  5 . This severed section  29  includes adaptor  14 , enabling it to be connected to tube  5  when the user is finished using the bag  2 , but has remaining medicaments in the bag  2 . The user will close tube  5  by first detaching adapter  13  from adapter  12  and then closing adapter  13  with cap  24 . Similarly, severed section  29  will be closed by sealing adapter  12  with cap  14 . The severed section  29  that is on the syringe is then used when the remaining contents of bag  2  are retrieved from storage. 
     In addition, once the bag  2  is filled it will reach the user as a pre-filled bag  2 . This allows the user to utilize the bag  2  without having to fill the bag  2  before using it, thus eliminating the usual problems associated with adding or filling a medicament bag or bottle out in the field, just prior to when the animal(s) will be injected. 
     A typical gun/syringe will include a serrated attachment point. The severed portion  29 , of tube  4 , will then slide over the serrated edge of the injection system, creating a tight and secure fit. Tube  4  will typically have a male adapter  14  which will then connect with the female adapter  13  of delivery tube  5 , thus allowing for the gun/syringe to pull one dose of material from the bag  2  at a time. 
     More preferably, the bag  2  will have a third opening  25  which is configured and dimensioned to receive a first end  26  of tube  6 . First end  26  is connected to opening  25  and buttressed by support  21 . Although tube  6  may be connected to bag  2  by any means, tube  6  is typically heat sealed or solvent sealed to the bag  2 . This will cause the tube  6  to be permanently fixed into the bag  2  itself. Tube  6  has a second end  19  that contains a stopper  15  for preventing contaminants from entering the bag system  1 . Preferably, this opening  25  is not utilized since it may compromise the sterility of the bag system  1 . Nevertheless, in some situations, the user may need to add additional items to the bag  2 , such as additional vaccine or vitamins. This can be accomplished by inserting a syringe or needle through the stopper  15  and discharging the additional vaccine or vitamin into the bag  2 . The stopper  15  is configured and dimensioned to interface with the opening  25  in the bag  2  so that the opening  25  is substantially sealed from outside contaminants. Similar to the other openings, it is preferred that opening  25  is constructed by having a rigid like support  21  at the interface between the opening  25  and tube  6  to insure a proper attachment of stopper  15 . 
     Any material may be used for the stopper  15 . Preferably, the stopper  15  will be made of a material that allows a syringe to penetrate through the stopper  15  and introduce the desired substances into the bag  2 . A preferred material of the stopping device  15  is rubber or similar material (i.e., a rubber stopper). 
     In a preferred embodiment of bag  2 , there is a seam  8  on the opposite end  27  of the bag  2  as openings  20 ,  21 , and  22 . The seam  8  separates the fluid storage capability of the bag  2  from a holding means  3  of the bag  2 . The holding means  3  (also called a slot) is used for holding the bag  2  in an upright position. Slot  3  is such that there is an ample opening for a hook or similar device which can be positioned through the slot  3 , thus maintaining the bag  2  in a desired position. 
     In a preferred embodiment, the bag  2  will contain a slot  3  and additional opening(s)  7  along the periphery of the bag  2  in order for the device to be hung or attached for support. Although it is not necessary to have openings  7  in the bag  2 , one or more holes/openings  7  can serve as additional means to support, position, or hold the bag  2  in a manner desired by the user. Moreover, the holes  7  can serve as a means of attachment to a support when moving the bag  2  to sterilize or treat the animals. In addition, the holes  7  can serve as a means of attachment when storing the bag before or after use. 
     The slot  3  can be located anywhere within the bag  2 . It is preferable if the slot(s)  3  is located on the opposite end  27  of bag  2 , away from tubes  4 ,  5 , and  6 . This way, the means by which the bag  2  is held or hung for support will be conveniently and safely out of the way from the end  28  where the gun or syringe is connected to the bag  2 . 
     Although not necessary, a seam  9  is on end  28 , near the openings  20 ,  21 , and  22  of the bag  2 . Seam  9  separates the fluid storage capability from the rest of the bag  2 , so that if desired by the user, additional holes  17  can be added to the bag  2 . These holes  17  can be used for a variety of means, however, the main use of these holes  17  will be for the user to further secure the bag  2  during use or storage. The holes  17  are of a size sufficient to secure the bag, for example, in a hanging arrangement. 
     Often times many animals need to be inoculated or provided with minerals and vitamins. Attempting to provide the particular fluid system to a few or large number of animals can take a considerable amount of time. Accordingly, carrying bag  2  around by hand can be very cumbersome, especially for the larger bag systems. The ability to strap bag  2  to a person or attach bag  2  to a more convenient portable means is clearly an advantage over traditional methods of delivering the fluids to animals. For example, securing bag  2  to a vest or pack would allow the user to carry the bag on the user&#39;s back. In another means, bag  2  may be secured to a portable apparatus such that the user does not have the strain of carrying bag  2  on his or her person. Furthermore, bag  2  has a capacity large enough so that the user can make numerous injections of the particular animal. 
     A benefit to the current invention is that it utilizes a system where the gun is attached to a hose or tube  5  which is itself connected to bag  2  that is holding the medicine, vaccine, vitamins etc. If a portion of the contents of bag  2  remains after the user is done treating the animal, the user can disengage tube  5  from the gun and place bag  2  in a storage facility, such as a refrigerator, and then retrieve the system when the need arises. 
     The size of the bags will also vary. Bag systems can comprise many different sizes, for example, ranging from about 1,000 ml to about 5,000 ml units. The typical bag system can hold around 2000 milliliters of material. However, the capacity of the bag systems will vary depending on the dosage necessary and the number of livestock. Any number of materials can be placed inside the bag. The desired materials may include any number of vaccines, medicaments, or vitamins that are necessary for the particular animal. Some materials include iron dextran, ampicillin, gentocin, B Vitamins, and many others. 
     While the preferred embodiments of the invention have been particularly described in the specification and illustrated in the drawings, it should be understood that the invention is not so limited. Many modifications, equivalents, and adaptations of the invention will become apparent to those skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims.