Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2000-11-02
2002-10-15
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
active
06466809
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to the field of oximeter sensors and, more particularly, to oximeter sensors having a laminated construction.
BACKGROUND OF THE INVENTION
Information on the amount of oxygen within blood or more preferably a blood flow is desirable in many instances. This is often characterized as the oxygen content or oxygen saturation of the blood. Oximeters are able to provide this type of information and are generally well known in the art. Patient data that is used by the oximeter to determine the oxygen content/saturation is monitored/measured by an oximeter sensor that operatively interfaces with the oximeter. There are at least generally two types of oximeter sensors—invasive and non-invasive. Invasive oximeter sensors are installed within the body through an appropriate aperture. Non-invasive oximeter sensors are installed on the exterior skin of an appropriate body part such as a finger or a foot.
Oximeter sensors typically employ a pair of light sources that emit light at different wavelengths, as well as one or more optical detectors. The power for the emitter and the oximeter signal from the detector are transmitted between the sensor head and the oximeter via a round multiple conductor cable. A round cable is the preferred configuration for conductor shielding and for cable manufacture. Electrical signals are provided by the oximeter to the oximeter sensor to operate the light sources in a predetermined manner (e.g., each light source is “pulsed” in accordance with a predetermined pattern). Light from each of the light sources will either be absorbed by the blood or will pass entirely through the patient's tissue and blood for receipt by the detector(s). Electrical signals from the detector(s) are provided back to the oximeter. Information on how the light sources are being operated, the wavelengths of these two light sources, and the amount of light which passes through the blood to the detector(s) are all used by the oximeter to calculate the oxygen content/saturation of the blood. This information will then typically be displayed for review by appropriate personnel.
Various factors contribute to the overall commercial success of a given oximeter sensor. One is its cost. Another is its comfort when positioned on the relevant body part. It would be desirable to have an oximeter sensor the could be made within certain cost constraints. It would also be desirable to have an oximeter sensor that provided at least a certain degree of patient comfort and would not cause breakdown of the patient's skin when worn for long periods of time. Enhanced patient comfort can be realized by things such as the size, shape, and weight of the oximeter sensor, as well as the having the oximeter sensor interface with the patient so as to at least reduce the potential for the development of “pressure points.” Uneven distribution of the forces being exerted on the patient by the oximeter sensor can contribute to the development of undesired soreness and possibly pressure necrosis on the patient's skin surface.
BRIEF SUMMARY OF THE INVENTION
The present invention generally relates to an oximeter sensor which utilizes a laminated construction and which provides a flat sensor/patient interface over at least those portions of the oximeter sensor housing which include an oximeter sensor cable. The oximeter sensor cable is used to establish an operative interface with an appropriate oximeter. Another way of characterizing the present invention is that it is directed to how a round oximeter sensor cable is interfaced with the patient's sensor site.
A first aspect of the present invention is embodied in an oximeter sensor that includes a laminated sensor housing. This laminated sensor housing is defined by first and second film assemblies which are appropriately interconnected, with the first film assembly the being that portion of the sensor housing that projects toward a body portion on which the oximeter sensor is mounted. Interconnection of the first and second film assemblies is provided by an appropriate seal, such as a heat seal or an integral adhesive film. In any case, each of the first and second film assemblies include at least one film. That is, one or both of the first and second film assemblies may in fact be defined by a plurality of individual films which may be interconnected by one or more of the above-noted techniques. It should be noted that each film within the first film assembly and each film within the second film assembly need not necessarily by of the same size, thickness, and/or shape. In one embodiment, the maximum thickness of each individual film in the first and second film assemblies is about 0.01 to about 0.04 inches.
The oximeter sensor of the first aspect of the present invention also includes an emitter assembly (e.g., one or more light sources and including a pair of light sources that emit light at different wavelengths) and a detector assembly which are each disposed between the first and second film assemblies within the oximeter sensor housing. A cable is electrically interconnected with both the emitter assembly and the detector assembly. This cable is also either connected with an oximeter or is at least interconnectable with an oximeter (directly or through one or more intermediate cables and an appropriate connector(s)). Part of this cable extends between the first and second film assemblies such that an end portion of the cable is actually disposed within the sensor housing. Notwithstanding this positioning of the cable within the sensor housing in this manner, that portion of the first film assembly which overlies this portion of the cable remains at least substantially flat. Having this type of flat profile in a laminated sensor housing construction reduces pressure concentrations and thereby enhances patient comfort.
Various refinements exist of the features noted in relation to the first aspect of the present invention. Further features may also be incorporated in the first aspect of the present invention as well. These refinements and additional features may exist individually or in any combination. The flat interface between that portion of the sensor housing which contains the cable and the body portion on which the oximeter sensor is installed is realized notwithstanding the fact that the cable is disposed within a sensor housing of a laminated construction. This cable is subject to a number of characterizations. One is that the cable is something more than a flat connector or the like. In one embodiment, the vertical extent or thickness of the cable is at least about 0.030 inches. One or more individual electrical conductors (e.g., wires) may collectively define the cable. Typically a single encasement (e.g., a piece of rubber tubing or the like) will be disposed about these plurality of individual electrical conductors, and this encasement may be of at least a generally circular cross section with a diameter that is within a range of about 0.070 inches to about 0.180 inches. The location where the cable exits the oximeter sensor housing is also relatively “close” to where the emitter or detector assembly is disposed. Consider the case where the emitter and detector assemblies are disposed along a first reference axis within the sensor housing, and where the cable extends within the oximeter sensor housing at least generally perpendicular to this first reference axis. In one embodiment, the distance between this first reference axis and the location where the cable actually exits the oximeter sensor housing, measured perpendicularly to the noted first reference axis, is no more than about 0.75 inches.
There are a number of ways of characterizing the interface between the cable and the first film assembly which again is that portion of the sensor housing which interfaces with the body portion on which the oximeter sensor is mounted. One way of characterizing this interface is that the contact between the first film assembly and the cable is at least substantially limited to
Datex-Ohmeda Inc.
Marsh & Fischmann & Breyfogle LLP
Winakur Eric F.
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