Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-05-10
2003-11-04
Huson, Gregory L. (Department: 3751)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S065000, C604S132000, C604S133000, C604S246000
Reexamination Certificate
active
06641562
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to administration of a medicinal fluid to a patient and, in particular, to low-cost, easy-to-use infusion systems for the intravenous dispensing of a fluid prescription.
2. Description Relative to the Prior Art
A wide variety of infusion systems are presently known in the medical art, particularly within the field of technology directed towards therapies requiring the use of intravenous medication. The administration of medication by intravenous delivery as prescribed by a medical doctor may be dispensed to the patient by an infusion system for certain therapies. The prescribed therapeutic liquid is referred to as the prescription or “Rx”, and is usually supplied by a pharmacist in a container such as a disposable plastic bag for use with an infusion system. The plastic bags usually have attached to them various components or elements which are useful in the infusion process such as various tubes and elements to secure the bag in place, to transport liquids (e.g., prescriptions, water, nutritional supplements, analyze solutions, etc.) with respect to the patient, to support the elements of the container, etc. This composite arrangement is usually referred to in the medical art as a “set”. The set is then loaded into a fluid delivery device called the “pump” either by a nurse or by the patient himself. Once the pump is connected to the patient, the device pumps the Rx through the conveying tubes of the set to infuse the patient.
The assembly of an infusion system, as presently known in the art, requires a certain degree of skill and manual dexterity. In some conventional infusion systems, the tubing of the set must be loaded into the pump, the set cleared, the set tubing meshed between rollers, and the roller gate closed. In a hospital setting, a nurse or medical technician is generally available to perform these dexterous steps and to instruct and/or supervise the patient in the loading and operation of the pump. It is also necessary for the physician, nurse or patient to program the rate of pump operation to control the fluid flow rate of the medication to the patient. Written records of the infusion system parameters must be generated and maintained for various medical reporting reasons. In the present day medical setting, many ill people are out-patients who must set up and operate their infusion system at home without the services of a knowledgeable practitioner to oversee proper assembly and performance of the system. Some patients may have debilitating illnesses or impacted conditions of memory dysfunction which leave them too weak or too forgetful to carry through complex assembly and programming procedures. With a rapidly growing aging population, many out-patient seniors may not have either the manual dexterity, physical strength, or mental acuity needed to cope with the demands of setting up and using current infusion systems. Additionally, with the downward economic pressures on all medical costs, and especially those of Medicare and Medicaid, a need exists for reducing the costs of these therapeutically essential infusion systems and minimizing the cost of technical assistance personnel.
U.S. Pat. No. 5,935,099 describes a menu driven reprogrammable drug pump is provided with a memory, such as flash memory, a display, a keyboard, and a communications port to allow a generic pump to be programmed with a desired pump application (therapy) program and patient specific settings. Programming and data transfer with another pump or a computer to and from the patient pump is by the communications port that allows local and/or remote communications with the pump. Flash memory stores the pump application program during use. Patient safety is provided by a cassette identification system, an occlusion detection system, and a latch/lock detection system. Automated testing of the pump is by a closed loop testing system. This system does not provide for unique pump identification, in combination with unique patient and therapy information. A limited range of pumping systems is also disclosed.
The present invention alleviates problems present in the prior art by providing a simplified, low-cost infusion system adapted for use both by in-patients in hospitals and by out-patients at home.
SUMMARY OF THE INVENTION
A therapy infusion apparatus for delivery of medicinal fluid to a patient may comprise:
a) a flexible therapy bag,
b) a movable surface which can apply force to an outside surface of the therapy bag to increase fluid pressure within said therapy bag,
c) an exit port in the therapy bag which will allow fluid to exit in a delivery direction from the flexible therapy bag under fluid pressure,
d) an adjustable, fluid control element located along the delivery direction, after the exit port.
The therapy infusion apparatus may be constructed with the therapy bag having at least one major face which comprises at least 25% of the total surface area of the therapy bag, and the movable surface can be moved into contact with the at least one major surface so that contact between the at least one major surface and the movable surface covers at least 50% of the surface area of the at least one major surface by the time that the movable surface is fully extended. The therapy bag may comprise at least two fluid flow ports within a fluid control element, one of the ports comprising the exit port, and adjacent to at least one of the ports is an element which has a storage area for a memory unit and access ports to the memory unit. The memory unit may comprise, for example, a chip (e.g., intelligence chip), and the access ports enable electronic connection from an outside memory reading or memory writing apparatus to the chip. The chip may be present within the storage area, and the chip preferably contains electronically readable information relating to at least two different topics selected from the group consisting of the prescription; the name of an active ingredient in the prescription; the chemical name of a prescription carrier; additives in the prescription; volume of the prescription; expiration date; name of a prescribing doctor; name of a private loader; name of a local supplier/manufacturer of ingredients of the prescription; source of at least some materials in the prescription; a name of a therapy bag manufacturer; a name of a pharmacist; a patient name; patient information relating to at least one of age, allergies, address, frequency of prescription refill, weight, chemical intolerances, instructions for a flow control module with respect to desired flow rates; intervals for delivery; rate and volume of delivery; and drip rate.
The therapy infusion apparatus preferably provides the movable surface as an extendable bladder which is expandable or inflatable by a fluid (e.g., liquid or gas) to move a surface of the bladder against a surface of the therapy bag.
A therapy bag for use in the infusion of liquids to a patient is described comprising a flexible bag having a storage area and a delivery end, the delivery end comprising at least two fluid ports, at least one port capable of allowing fluid from within said storage area when pressure is applied to liquid within the storage area, and the delivery end also having a storage area for storage of a memory element, the storage area having access ports for electronically accessing the memory element. The storage area preferably contains a memory storing element such as a chip and there are electronic access ports oriented in the storage area to allow external electronic access to the chip so that information on the chip may be accessed. The storage area may be asymmetrically located along the delivery end. At least two liquid flow ports may be located to one side of the asymmetrically located storage area. A battery may be located on the same side or the other side of the ports as the storage area for the memory unit. The battery may provide power to any electrical or electronic element on the pump or apparatus, such as at least one electrically powered
HPS Medical, Inc.
Huson Gregory L.
Mark A. Litman & Assoc. P.A.
Nguyen Tuan
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