Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
1999-10-14
2002-01-29
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S310000
Reexamination Certificate
active
06343224
ABSTRACT:
BACKGROUND OF THE INVENTION
Heretofore the use of pulse oximeter probes has been limited to the use of a costly reusable probe, which is contaminated by use on a patient, or cheaper, single-use probes, which, in the aggregate, amount to a considerable expenditure for a health care institution. The present invention relates to a method of making and affixing a reusable probe to a patient by means of disposable bandage apparatus so that there is no contact between the costly, reusable portion of the probe and the patient. The contaminated bandage apparatus, which is relatively inexpensive, can then be discarded after single patient use and the probe can be reused with a new bandage apparatus. that process, the original adhesive material is removed from the original manufacturer's sensor. The sensor is then laminated in a plastic sheath and the entire sheath is then inserted into a transparent, adhesive-backed sleeve, which is then adhered to a patient. After use, the probe can then be extracted from the sleeve and inserted into a new sleeve for use on another patient.
There are certain disadvantages to this method. Firstly, it is difficult to insert the flexible laminated sensor into a long sleeve. Secondly, the thickness of a laminated sensor inside of a sleeve makes it difficult to bend around, and to stick properly to, a human appendage. Thirdly, transmission and reception of infrared light can be affected by extraneous light entering from the sides of the sleeve. And, Fourthly, there is some dispute as to the affect on infrared light transmission when passing through the sleeve and the adhesive material coupled thereto.
THE PRESENT INVENTION
The present invention not only solves the problems outlined above, but offers an alternative that is cheap to manufacture and easy to use.
In detail, the present invention is a method for improving the form and affixation method of a reusable pulse oximeter sensor. It comprises a reusable pulse oximeter probe with at least one light-emitting diode and one photocell detector wherein the emitter and detector are enclosed in plastic housings, one housing having an aperture or radiation transparent window aligned with the emitter, and the other housing having an aperture or radiation transparent window aligned with the detector. Also included is a disposable bandage apparatus which is a bandage strip having adhesive on at least a portion of at least one face thereof and at least two plastic receptacles mounted thereon, each receptacle having at least one aperture or radiation transparent window located therein. The probe housings can matedly engage the bandage receptacles and transmit and receive light through the apertures or radiation transparent windows of the mated housings and receptacles, and through the appendage of a patient. The apertures of the receptacles are large enough to accept the tubular protrusions of the housings for the purpose of concentric location and alignment of the housings to the receptacles and the proper transmission and reception of light therethrough. Sandwiched between the adhesive strip and the receptacles attached thereto, are translucent silicone windows or windows of another radiation transparent material for isolation of the reusable probe assembly from the patient. The bandage apparatus may be discarded after single patient use and the reusable probe may be used again on another patient in conjunction with another bandage apparatus. Additionally, the receptacles of the bandage apparatus may have a concave surface on one side thereof in order to seat conformably on a human digit, or they have a flat surface on at least one side thereof in order to attach conformably to a human foot, nose,or ear. The housings and receptacles also contain “mushroom hook” type hook and loop material for the purpose of adhering and detaching the housings to and from the receptacles. Additionally, the housings and receptacles have recessed areas for adhesion of the “mushroom hook” hook and loop material.
In another embodiment of the invention, the receptacle of the disposable bandage apparatus may be the mushroom hook material itself which may be attached directly to the adhesive strip for the selective engagement of the housings of the probe assembly.
Finally, and in the preferred embodiment of the invention, the light-emitting diode and photocell detector of the probe assembly may be mounted in modular housings with locking levers which can engage an indentation or slot in the receptacles and securely lock the housings into proper position within the receptacles, thus allowing the transmission and reception of infrared light through the mated housings and receptacles and through the appendage of a patient. In this embodiment, the silicone, or other radiation transparent windows, may be mounted against the skin of a patient, and may be used to secure the receptacles on the opposite side of the bandage strip. This is accomplished by the use of locking levers which are pushed through holes or slots in the bandage and engage the receptacles mounted on the opposite side of the bandage, thus sandwiching the bandage in between.
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Sensidyne Inc.
Winakur Eric F.
Zegeer Jim
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