Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2001-08-17
2003-07-08
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S340000
Reexamination Certificate
active
06589172
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a switching device for manually or automatically selecting a certain signal among a plurality of signals generated by a plurality of medical sensors. In certain situations, a patient may be simultaneously monitored at various locations for the same physiological information. The switching device of this invention allows the attending medical staff to read the various outputs from the various sensors by selecting the desired information source.
BACKGROUND OF THE INVENTION
The use of multiple sensors is conventional in the medical field. Usually each sensor has it's own discrete instrument for reading or otherwise obtaining the information produced by the sensor. In one situation several physiological parameters are being measured simultaneously and in a second situation the same parameter is measured at various points on the patient's body for comparison. In a third situation there may be multiple sensors collecting the same information simultaneously with other sensors collecting different information. Conventionally, in these situations there are lines from each sensor to each monitor. This quickly deteriorates into confusion and clutter about the patient.
Exemplary of this invention are transcutaneous oxygen (O
2
) and carbon dioxide (CO
2
) sensors, pulse oximetry sensors, such as disclosed in Ser. No. 09/586,925, incorporated herein by reference, blood pressure cuffs, arterial pressure lines (A lines), and airway pressure lines. Each of these different sensors has a particular lead for presenting the specific data in a standard form. The switching device has at least two ports for each of these leads.
Any or all of these sensors may be used in the operating room (OR) and the intensive care unit (ICU), as well as, in other applications, to provide information regarding the oxygen and/or carbon dioxide levels in a patient's blood, temperature, blood pressure, airway pressure and arterial pressure.
In transcutaneous sensors, for example, gas exchange between the blood and the skin results from oxygen diffusing out of capillaries and migrating outwardly through the stratum corneum to the atmosphere. The partial pressure of oxygen can be measured, noninvasively, at the skin surface.
A conventional transcutaneous oxygen sensor is made up of a modified polarographic Clark electrode which includes an anode and cathode of noble metals, an electrolyte, a semipermeable membrane, and a heating element. The heating element increases skin temperature and increases blood supply thereby increasing oxygen diffusion. The heating element may be controlled by thermistors set for high and low temperatures.
As the oxygen passes through the skin, it diffuses through the semipermeable membrane and dissolves in the electrolyte. The voltage between the cathode and anode converts the oxygen to hydroxyl ions. The current generated by this reaction is directly proportional to the partial pressure of oxygen in the underlying tissues. A processor receives the current and converts it to millimeters of Mercury, line graph, bar graph or other symbols and displays it on a monitor or print out.
Carbon dioxide is generated in the tissues adjacent the surface of the skin as a by-product of cellular metabolism and diffuses across the skin. The partial pressure of the carbon dioxide can be measured by a transcutaneous sensor. A conventional carbon dioxide sensor is made up of a Severinghaus pH electrode, a reference electrode, an electrolyte solution, a semipermeable membrane and a heating unit. The diffusing carbon dioxide passes through the semipermeable membrane adhered to the skin and into a dilute bicarbonate solution. The pH of the solution is lowered by the CO
2
and the glass electrode measures the change. The electrode output is processed to a signal recorded directly as the partial pressure of CO
2
. The monitor shows the value on a digital display or other recording devices.
There are conventional transcutaneous sensors that measure both O
2
and CO
2
. Such sensors are associated with monitors/processors that measure both O
2
and CO
2
. Usually, these sensors and monitors are composites of each of the devices described above incorporated into one shell or one cabinet.
Conventionally, one transcutaneous sensor, whether an O
2
or CO
2
sensor, is associated with a single monitor as a single system. If a problem occurs in either the sensor or the processor, the entire system is replaced with another system. The same is true of the other sensor/monitor combinations mentioned above.
It is especially important to maintain a sterile field in the OR and the ICU. The equipment used in these locations should be sterile, also. The oxygen and carbon dioxide levels in the patient's blood are constantly monitored, along with blood pressure, temperature and breathing to determine the patient's well being in both these settings.
In certain situations in the OR, during surgery, blood flow in a particular part of the body may be interrupted or shunted into other fields. Such an event may cause the interruption of the sensor readings, if the system is located on an extremity in the affected part of the body. To immediately reestablish this vital information, the sterile field may be invaded to place another system on the body or to move the affected system to another suitable location on the patient. Using the switching device of this invention, another sensor, already in place, is selected without disturbing the sterile field.
This situation may also occur in the ICU. Also, in the ICU the patient may cause the sensors to become dislodged through body movement. Of course, there are other mechanical reasons that a system may malfunction and require replacement. This important information concerning the patient's vital signs is lost during the period of time required to position a new system. Using the switching device of this invention the flow of information can be re-established by moving a selector.
In wound care situations, for example, multiple sensors are used to map the O
2
levels in particular areas of the body. For example, if there are sores or wounds that are slow to heal, due in part to poor circulation, the blood oxygen level is useful in determining the ability of the wounds to heal. Normally 3 to 5 sites are used to give an indication of the situation in the particular area of the body and to compensate for any anomaly at any sensor. Conventionally, this mapping requires 3 to 5 processors. With the present equipment, readings from the various locations may be gathered and compared by moving the selector.
One side effect of the transcutaneous sensors, in particular, results from the use of the heating ring which increases blood flow at the sensor. Varying degrees of burns may result in thin skinned infants and adults with peripheral vascular impairment. Frequent sensor relocation, as recommended by the manufacturer, alleviates this side effect. However, relocation may require recalibration and there may be a 30 minute period necessary to stabilize the sensor on the new site. By rotating the activation of the sensors, the heat build-up at each sensor is shortened.
Thus, what is needed in the art is an apparatus that will provide continuous readings of several vital signs without disturbing the patient or the sterile field when blood flow to a particular part of the body is interrupted or a sensor fails. Also, when mapping an area of the body, different sensors, already in place, may be sampled sequentially or in a random fashion and displayed on a single monitor.
DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 5,957,854 issued to Bessom et al, Sep. 28, 1999, teach the conventional use of multiple sensors wired to a monitor for EKG readings. The patent replaces the multiple wires with wireless sensors having antennae.
U.S. Pat. No. 5,279,297, issued to Wilson et al, U.S. Pat. No. 5,501,225 issued to Wilson Mar. 26, 1996 and U.S. Pat. No. 5,593,899 issued to Wilson et al on Jan. 14, 1997 all teach the use of a phosphorescent dye in
Williams Bill
Williams Glenn
Kremer Matthew J
Larson James E.
Larson & Larson, PA
Winakur Eric F.
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