Fluid delivery device with temperature controlled energy source

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S095030

Reexamination Certificate

active

06245042

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to fluid delivery devices. More particularly, the invention concerns a device for the delivery of beneficial agents to ruminants.
DESCRIPTION OF THE PRIOR ART
It has long been recognized that the delivery of various types of nutrients, drugs, dietary supplements and trace elements for grazing animals, such as sheep and cattle is highly beneficial to the well being and growth of the animal. By way of example, delivery to the grazing animal of various types of antiparasitics can be used to control mange mites, sucking lice, cattle grubs, fly larva, ticks and the like. Similarly, delivery of anti-bacterials such as sulphonamides has proven effective for disease control. In like manner, the delivery of monesin sodium as an anti-bacterial agent has proven effective as a growth promotion in cattle and sheep and the delivery of S-methoprene has been shown to be effective to control pupa of the horn fly in the manure pat.
Commonly, grazing animals such as cattle and sheep are turned out in the spring to spend much of the spring, summer and autumn season grazing the open range. With such animals the periodic administration of drugs is complicated by the need to retrieve the animal and then, after retrieval, to effectively administer the nutrient or drug to the animal. For example, one of the principal problems involved in the control of livestock pests has not been the unavailability of effective toxicans, instead it is the relatively short duration of effectiveness of the available compounds due to photodecomposition, evaporation, and absorption of the materials, and due to mechanical losses caused by rubbing of the animal, muscular contractions and the like. Additionally, repeated treatment of livestock is expensive in terms of both labor and insecticides. To compensate for the rapid degradation of the pesticides on animals, the producer must apply larger quantities than are necessary for control of the immediate population if toxic levels are to be maintained for any length of time. Such a practice is wasteful of insecticides, results in greater contamination to the environment and increases the probability of toxicity to animals and the residues in animal products.
In light of the foregoing, for many years, it has been an objective of the industry to develop techniques that would make it possible to maintain the minimum effective level of toxicans in livestock over an extended period and thereby increase the efficiency and safety of livestock pest control. Additionally, the cumbersome and labor intensive process of introducing any drug, medicament or other substance into the daily food supply, which is ingested orally by the ruminant, provides little or no assurance that the required amount of agent will have been administered as food intake will vary with each feeding. The use of a controlled-release drug delivery device is an attractive alternative because such an approach has the significant advantage of providing the animal with nutrients and medicaments, which will be released in a controlled manner into the body over a period of time.
It is known that the rumen is a suitable site for the administration of drugs to a ruminant. The drug formulation can be injected directly into the rumen through the flank of the animal. Alternatively, a controlled release drug delivery device can be introduced via the mouth of the animal in which case it is desirable for the device to be retained within the reticulo-rumen for controlled release of the drug formulation thereafter. One method of retaining the device within the rumen is to arrange for its geometry to alter once it is in the rumen. For example, wings extended laterally from the main body of the device can retard or prevent regurgitation thereof by the animal. Alternatively, the device may be made sufficiently dense for it to be retained in the rumen simply by the force of gravity. For example, prior art experimentation has shown that retention in the rumen can be achieved by providing a device having an overall device density greater than 2.0.
The prior art drug delivery devices for use in rumens typically fall into the classes of erodible devices, reservoir devices, osmotic devices, and pulsatile devices. Erodible devices are designed to dissolve or abraid as a result of solutions within the rumen or due to mechanical action of the rumen. Exemplary of one prior art erodible system is that described in U.S. Pat. No. 3,056,724 issued to H. R. Marsten. Marsten discloses an erodible bolus, which is, provided in the form of a pellet containing cobalt oxide and other diluents that function to produce a product that releases cobalt to the animal for the full grazing season. Another example of a prior art erodible bolus is that described in U.S. Pat. No. 4,166,107 issued to Miller et al. Miller et al discloses a sustained release bolus containing compositions of insect regulators to control the larval activity of arthropods in the manure of livestock.
Exemplary of a prior art reservoir type device is the device described in U.S. Pat. No. 4,959,218 issued to Eckenhoff et al. This patent describes a delivery device comprising a housing having an internal space, a beneficial agent in the space, expandable means in the space for causing the beneficial agent to be delivered from the device and means in the space for shielding the beneficial agent from fluid. An earlier Eckenhoff et al U.S. Pat. No. 4,595,583 discloses a somewhat similar reservoir device comprising a semipermeable housing defining an internal space, a dense member in the space, a heat responsive composition containing a beneficial agent in the space, an expandable member in the space, and a passageway in the semipermeable housing for delivering the beneficial agent from the dispensing device. The heat-responsive composition comprises a heat sensitive, hydrophilic or hydrophobic material that exhibits solid-ike properties at room temperature and exhibits a melting point that approximates mammalian body temperatures of 37 degrees centigrade. When administered to the ruminant, this heat responsive composition, which contains the beneficial agent, is heated by the animal's body and becomes liquid through phase change, thus allowing it to flow outward of the device.
The prior art osmotic devices take several forms. One such device is described in U.S. Pat. No. 3,845,770 issued to Theeuwes et al. This device comprises a wall surrounding and forming a compartment for containing a useful composition of matter and has a passageway for dispensing the composition. The wall is comprised, in at least a part, of a material permeable to an external fluid. The composition is soluble in the fluid and exhibits an osmotic pressure gradient against the fluid or the composition has limited solubility and is admixed with an osmotically effective compound soluble in the fluid that exhibits an osmotic pressure gradient against the fluid. In operation, the composition is dispensed from the device by fluid permeating into the compartment producing a solution of the soluble composition or a solution of the osmotically effective compound containing the composition, which solution in either operation is released through the passageway to the exterior of the device at a rate controlled by the permeability of the wall and the osmotic pressure gradient across the wall of the device.
Pulsatile systems consist of systems which release multiple doses at preprogrammed intervals. The advantages of these systems are that they tend to better mimic prior art methods of administering multiple doses of immediate release products given at specific time intervals. Exemplary of one form of prior art pulsatile system is that described in U.S. Pat. No. 4,381,780 issued to Holloway. Holloway describes a system consisting of a series of degradable partitions that form compartments within a body. The partitions are made from cellulosic materials that degrade in the rumen thus releasing the drug successively from the compartments. The drug dosage is controlled

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