Surgery – Controlled release therapeutic device or system
Reexamination Certificate
2000-08-25
2003-12-30
Hayes, Michael J. (Department: 3763)
Surgery
Controlled release therapeutic device or system
C604S131000, C604S179000, C340S573300, C340S539120
Reexamination Certificate
active
06669682
ABSTRACT:
TECHNICAL FIELD
The invention relates to a method and an apparatus for the transport of one or more fluid substances between respective reservoirs and predetermined sites in or on the body of an animal.
In particular, the invention enables one or more substances to be delivered to, and/or collected from, respective sites in or on the body of an animal. Such sites include internal sites, such as natural body cavities, e.g. vaginal, nasal and buccal cavities.
The method and apparatus is particularly suitable for unsupervised substance transport over an extended period on ambulatory animals.
The invention is suited to use on an animal and particularly to domestic cattle or other quadrupeds such as pigs, goats, sheep or deer. The invention could be adapted for use with birds. In a particular embodiment, it relates to an apparatus attached to a cow for the delivery of a substance such as a therapeutic agent, to the cow.
BACKGROUND ART
Substance delivery devices are known for administration of substances to the human body.
U.S. Pat. No. 3,547,322 discloses an apparatus for intravenous administration, to a human patient, of a fluid from a container supported by a harness and secured externally to the body of the patient. The apparatus is said to allow the patient to move about, or be moved about, during such intravenous administion. The apparatus is unwieldy and totally unsuited for unsupervised field use on freely ambulatory animals.
U.S. Pat. No. 5,728,070 discloses a portable medication dispenser system in which a harness, e.g. a waist belt and an optional shoulder strap, externally worn by a human patient supports a container holding the medication, e.g. in a pocket at one location, and a pump at another location. Tubing interconnects the container, the pump and a catheter by which medication is introduced into the body of the patient. The harness is formed from elasticized fabric. The system is not suited to the delivery and collection of substances on freely ambulatory field animals left unsupervised for an extended period.
The delivery of substances to living non-human animals has commonly involved injections or devices requiring surgical implantation or retention within a natural body cavity, for example, the rumen or the vagina. The administration of substances by injection often causes abscesses and high levels of the substances are frequently found at the injection site at slaughter. Injections also can damage the hide and are therefore restricted to particular sites, e.g. to the neck region. Many drugs do not achieve their maximum therapeutic action through conventional injection techniques. The therapeutic action of such drugs is improved considerably when delivered at a controlled rate to maintain optimum drug concentration for a specific period. In a typical drug injection, a greater drug concentration than necessary must be administered to keep the drug concentration within the effective therapeutic margin for the minimum period necessary for treatment. With controlled drug infusion, the drug can be given at a precise rate that will keep the drug serum concentration above a therapeutic minimum and below toxic levels. Many drugs reach their fill potential effectiveness only through precise delivery over extended periods of time.
In animal husbandry the administration of drugs to animals involves a great deal of handling which is laborious for the handler and stressful for the animals. Often animals must be brought in from long distances making prolonged or frequent treatment difficult if not prohibitive. In some cases the stress levels caused by handling stock can impair the performance of the treatment, this is particularly true in deer. Many drugs are given in slow release capsules that can cause problems when still remaining in the animal at slaughter.
Many formulations are designed for long release to reduce stock handling requirements but concentrations often fall below the effective therapeutic levels long before the next dose is administered thus increasing the risk of drug resistance. Bacterial drug resistance is a growing problem that affects both animals and humans and commonly arises from the ineffective administration of drug treatments. Parasite drug resistance is now a major problem particularly with anti-parasite drugs such as anthelminthics.
Devices for implantation or insertion require a means for releasing the substance into the body. This may be by controlled diffusion or by the action of a pump. Some devices incorporating pumps use a battery as a power source linked to the pump via simple electronic circuitry. Difficulties arise when internally located devices, such as surgically implanted or intra-ruminal devices, remain in animals at slaughter.
One application of such devices has been the control of the timing of oestrus of domestic animals.
U.S. Pat. No. 3,499,445 discloses the blocking of oestrus by the surgical implantation of a pellet containing a hormonal medicament, and the subsequent initiation of oestrus by the subsequent surgical removal of the pellet.
There are many disadvantages in techniques requiring surgical implantation of substance delivery devices. The device requires surgical intervention for implantation and for removal of the device. There is limited control over dose timing and dose rate. There is no interruption of the dose or variation of the dose substance without surgical intervention. There is no indication of satisfactory operation of the device and no monitoring of physiological or other animal parameters. Substances cannot be collected from the animal. There is a wide variation in the uncontrolled rate of delivery of the substance, and the volume of material that can be delivered is limited by the size of the surgical implant.
Many drug treatments on firs require the sequential and accurately timed delivery of more than one substance to achieve the desired result. This is particularly true of hard to breed stock that require treatment with up to three hormones in a precisely timed delivery programme to effect oestrus. These types of treatment require frequent visits by the veterinarian and are therefore normally reserved for valuable stock.
Some cattle problems such as facial eczema are treated with daily drenches of minerals in low amounts. This is difficult enough with dairy or milking stock but is a particular problem for dry stock, which must be yarded each day.
WO 96/00106 discloses an implantable drug delivery pump system including a sensor, a pump controller, pumps and delivery systems, all preferably implanted within a body. The pumps deliver a controlled volume or a controlled rate of two or more substances, e.g. an agent and counter-agent, to the body, in response to a body condition sensed by the sensor, e.g. temperature, pressure or the presence of glucose or other constituents. The pumps are preferably electrically controlled and may be any conventionally known pump, e.g. piston, peristaltic or centrifugal.
WO 94/01165 discloses a medication-administering device in the form of a ‘smart’ capsule for introduction into a body cavity. The capsule is said to be particularly suited to being taken orally, but may form a suppository for taking other than orally, or may be surgically introduced to a body. The capsule casing is insoluble in body cavity fluids and contains a reservoir containing the medication which is expelled into the body cavity by a pump driven by an electrolytically-generated gas. A microprocessor controls the rate of delivery of the medication which may be varied in response to body conditions, eg pH, temperature, sound or moisture, monitored by sensors included in the capsule. An electrolytic cell co-operates with body fluids surrounding the capsule to generate electrical power to supply the microprocessor and the gas generator. The capsule may also include a radio transceiver enabling the location of the capsule to be monitored, or the operation of the capsule to be controlled, from outside the body.
The insertion of a device completely within a body cavity imposes several limitations and di
Gibson David John Michael
Norris Christopher Seton
Bryher Holdings Limited
Ghafoorian Roz
Hayes Michael J.
Jacobson & Holman PLLC
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