Dispensing – With discharge assistant – Container with follower
Reexamination Certificate
2001-07-31
2003-05-13
Derakshani, Philippe (Department: 3754)
Dispensing
With discharge assistant
Container with follower
C222S146500, C222S263000
Reexamination Certificate
active
06561389
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to dispensers for dispensing medical grade ultrasound gel onto the body of a patient in a region which is to undergo ultrasound examination. In particular, the present invention is directed to such dispensers that effectively preclude cross-contamination whereby pathogens maybe transferred from one patient to the next as a consequence of the use of a common gel dispensing apparatus which is used for more than one patient.
BACKGROUND OF THE INVENTION
The particular purpose of the present invention is to provide a dispensing apparatus which will dispense medical grade ultrasound gel onto the body of a patient in such a manner that the risk of cross-contamination from one patient to the next is effectively precluded; while at the same time the comfort of the patient may be assured by dispensing medical grade ultrasound gel which has been warmed to above ambient or room temperature.
In particular, it is a purpose of the present invention to provide a dispenser for medical grade ultrasound gel which assures that the medical grade ultrasound gel remains uncontaminated in the same condition that it has been received from the manufacturer, until such time as the ultrasound gel is dispensed. At the same time, it is assured that harmful pathogens which might be contacted by the gel dispenser from the body of a patient are not transmitted to another patient.
When ultrasound gel is delivered to the body of the patient, it is typically spread around on the body of the patient in the area which is to receive an ultrasound examination. The purpose of the ultrasound gel is to provide coupling between the ultrasound probe and the body of the patient, since the ultrasound waves are not transmissible through air but require a more dense medium.
Typically, ultrasound gel is relatively costly, so it is desired to be able to dispense only enough gel for the ultrasound procedure to be undertaken, while preserving gel in the dispenser being used for the next ultrasound procedure on another patient. Otherwise, it would be necessary to produce single use ultrasound gel containers, probably of varying sizes depending on the amount of gel to be dispensed for any particular ultrasound procedure, and that suggestion is prohibitively expensive. Accordingly, it is most usual that an ultrasound gel dispenser shall contain more ultrasound gel than is required for any specific procedure, and typically the ultrasound gel dispenser is refillable.
However, when an ultrasound gel bottle is used to prepare a patient, which may be human or a veterinary patient, for an ultrasound procedure, the gel dispenser comes into contact with the body of the patient. Therefore, the gel dispenser maybe exposed to body fluids; and if so, the gel dispenser may become contaminated with pathogens such as bacteria, fungi, parasites, and viruses. Of course, such pathogens may then be transmitted to another patient during a subsequent procedure.
The medical grade ultrasound gel which may be dispensed in keeping with the present invention, and as it is dispensed in the prior art devices being discussed, may have differing viscosities. Typically, a gel which is used for diagnostic procedures is less viscous than a gel which is used for therapeutic ultrasound procedures. The reason is, in particular, that medical grade ultrasound therapeutic gels may be placed on a smaller area of the patient of the body than would typically be the case when an ultrasonic diagnostic procedure is to be carried out.
In any event, there is a concern that pathogens can be transmitted to another patient during a subsequent procedure, particularly if the gel dispenser has been positioned around an open wound for a given procedure. This is of even more concern when a gel dispenser may be used on a patient who is suffering from AIDS, or is otherwise immuno-comprised such as is the consequence of following an immuno-suppression drug regimen.
A recent study by a major hospital in Toronto, Canada, showed that more than 100 different kinds of bacteria may be found on a dispenser used for dispensing medical grade ultrasound gel.
Quite often, such dispensers take the form of a bottle—not unlike a ketchup bottle used in household kitchens and the like—from which the medical grade ultrasound gel is to be dispensed. If so, typically the medical grade ultrasound gel is purchased by the hospital or medical laboratory or veterinary clinic in bulk, and the dispensing bottles are filled every five to ten patients in a typical use experience.
It is usual that such gel bottles are managed by being wiped with an alcohol swab before being refilled from the bulk container, and between patients. However, particularly when the gel bottle is to be refilled, it is typically not completely empty before the new gel is to be introduced into the bottle, and therefore the new gel may be exposed to any contaminants or pathogens that are to be found within the gel dispensing bottle. This is because the bottle has only been wiped around the exterior of the cap area and not the interior of the cap or the interior of the bottle. Moreover, the process of refilling the ultrasound gel dispenser bottles is labour intensive, time consuming, difficult, and therefore costly, and it does not fully address or typically ignores the contamination problem. Even if a cleaning and disinfectant procedure has been followed, it is not always effective because it may be possible that the interior of the bottle is not clean.
The present invention presupposes the availability of a source of pressurized medical grade ultrasound gel, to which the dispenser of the present invention is connected in fluid communication with that source. However, the details of the pressurized source of medical grade ultrasound gel are beyond the scope of the present invention.
Moreover, by being in fluid communication with a pressurized source of medical grade ultrasound gel, the assurance is given that each time ultrasound gel is dispensed using the dispensing apparatus of the present invention, the dispensed volume is replaced from the external source of pressurized medical grade ultrasound gel. This assures that the gel remains uncontaminated, because there is no necessity to open the dispenser; and as will be discussed hereafter, there is no opportunity for pathogens to transfer from a patient into the dispenser because of the structure of the dispenser and also because typically a disposable cap member is employed. As will be discussed hereafter, the cap member is very inexpensive, and thus a new, sterilized or at least antiseptic cap member may be used each time the medical grade ultrasound gel is to be dispensed onto a new patient.
The present inventor has quite unexpectedly discovered that a structure for a dispenser apparatus for use in dispensing medical grade ultrasound gel onto the body of a patient, which assures hygienic conditions with respect to the medical grade ultrasonic gel until such time as it is dispensed onto the body of a patient, may be provided using a closed container having a plunger and a sealing plate which will eject the ultrasound gel from the dispensing apparatus while, at the same time, assuring that the dispensing apparatus is refilled from a source of pressurized medical grade ultrasound gel.
Because of the structure of the ultrasound gel dispensing apparatus, particularly when a cap member is employed on the apparatus, contamination of the interior of the dispenser apparatus is precluded. Additional features of the present invention optionally allow for the medical grade ultrasound gel to be heated to above ambient or room temperature, and particularly provide for the use of disposable cap members having significantly low unit costs.
Accordingly, medical grade hydraulic gel dispensers are provided by the present invention which promote at least hygienic and antiseptic conditions, preclude cross-contamination between patients, and assure comfort to the patient by dispensing ultrasound gel which has been warmed.
DESCRIPTION OF THE PRIOR ART
Kozam U.S. Pat.
(Marks & Clerk)
Cartagena Melvin
Derakshani Philippe
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