Piston-actuated attachable topical fluid delivery system

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

Reexamination Certificate

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C604S207000, C604S186000

Reexamination Certificate

active

06224572

ABSTRACT:

BACKGROUND OF THE INVENTION
1. The Field of the Invention.
The present invention relates generally to fluid delivery systems, and more particularly to lightweight, miniaturized fluid transport systems suitable for a variety of uses including topical and intravenous fluid delivery.
2. The Background Art.
The administration of fluids to patients is a well-known medical procedure for, among other things, administering life sustaining nutrients to patients whose digestive tracts are unable to function normally due to illness or injury, administering antibiotics to treat a variety of serious infections, administering analgesic drugs to patients suffering from acute or chronic pain, administering chemotherapy drugs to treat patients suffering from cancer, etc.
The intravenous administration of drugs frequently involves the standard syringe and needle. This simple method is not conducive to a progressive and systematic delivery of multiple doses of fluid over a longer time period. It is known to meet such needs with the use of an IV pump connected or built into a so-called IV administration set including, for example, a bottle of fluid to be administered and typically positioned upside down, a sterile plastic tubing set, and a pump for pumping fluid from the bottle through the IV set to the patient. Other mechanisms may be included to manually stop the flow of fluid to the IV feeding tube and possibly some monitoring devices.
Current IV pumps generally are of two basic types: electronic pumps and disposable non-electronic pumps. Although the electronic pumps have been significantly miniaturized and do include some disposable components, they are nevertheless generally high in cost, require frequent maintenance with continued use, and may be difficult for a layman to operate if, for example, self treatment is desired.
The disposable non-electric pumps generally consist of small elastomeric bags within a hard shell container, in which the bags are filled with IV solution under pressure. The pressure generated by the contraction of the elastomeric bag forces the IV solution through a fixed orifice at a constant flow rate into the patient's vein. Although these pumps are much less expensive than the electronic pumps and eliminate the need for maintenance (since they are discarded after every use), their drawbacks include the lack of monitoring capability, the lack of the ability to select different flow rates, limited fluid capacity, and still relatively high cost for a disposable product.
It is often desirable to accomplish fluid delivery by a topical administration of the fluid to allow the fluid to drift into the skin by osmosis. The HARTS COLLAR™ is known in the art to include a porous fluid holder for strapping around the neck of a patient, usually a dog. The porosity of the collar is designed to release the contained fluid from the collar at a desirable rate onto the skin of the patient to enable the skin to gradually absorb the fluid. The drawbacks include nonuniform application due to movement of the patient, nonuniform delivery rates, and the lack of ability to select different flow rates.
OBJECTS AND SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a fluid delivery system which is especially suitable for use in topical administration of fluids to a patient, either human or animal.
It is another object of the invention to provide such a fluid delivery system which utilizes a pump structure to pump multiple fluid doses of predetermined volume to the patient.
It is a further object of the invention to provide such a fluid delivery system which is easy to manufacture and which utilizes low cost parts.
It is an additional object of the invention to provide such a fluid delivery system which is efficient and reliable.
It is another object of the invention, in accordance with one aspect thereof, to provide such a fluid delivery system having a pump structure which is configured to sweep bubbles from a pumping chamber during operation.
It is still another object of the invention, in accordance with one aspect thereof, to provide such a fluid delivery system having a readily changeable flow rate.
It is yet another object of the invention, in accordance with one aspect thereof, to provide such a fluid delivery system which is portable and miniaturized so as to be carryable by the patient.
It is an additional object of the invention, in accordance with one aspect thereof, to provide such a fluid delivery system which delivers doses of fluid to the patient according to a timed sequence.
The above objects and others not specifically recited are realized in a specific illustrative embodiment of pumping apparatus in combination with valved guide channels. A piston-actuated pump utilizes a simple circumferential polymeric seal, or sphincter seal, to retain and prevent loss or leaking of the fluid being pumped. A housing defines an elongate cavity with an opening formed in a first side of the housing, and an opposing second side of the housing is closed. A resilient sheet of material is disposed over the opening in the housing, with the sheet including an aperture positioned in alignment with the cavity at the first side. An elongate shaft is slidably disposed in the aperture so that one end of the shaft extends into the cavity and the other end extends out of the housing. The aperture has substantially the same cross-sectional shape as that of the shaft, and the same cross-sectional dimensions or smaller. An inlet is provided in the housing, through which fluid from a fluid source may flow into the cavity, and an outlet is also provided in the housing, through which fluid may flow from the cavity to a fluid sink. The resilient sheet of material surrounds and grips the shaft at the aperture in the sheet to provide a sphincter seal which prevents fluid from flowing through the aperture but allows the shaft to slide longitudinally therein.
When the shaft is moved in a direction outwardly of the housing, a negative pressure is produced in the cavity to draw in fluid through the inlet, and when the shaft is moved inwardly into the cavity, a positive pressure is produced in the cavity to force fluid from the cavity through the outlet. Check valves may be provided in or near the inlet and outlet to allow fluid only to flow into the cavity through the inlet and out of the cavity through the outlet.
A variety of driver mechanisms and control methods may be provided to cause the shaft to reciprocate within the cavity to produce the pumping action, including ratchet drives, magnetic linear step motors, rotary-to-linear crank drives, and screw drive mechanisms. A variety of valves using sphincter seals and similar mechanisms may be provided to control fluid flow in the pump, among other mechanisms.
Additional objects and advantages of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by the practice of the invention. The objects and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims.


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pa

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