Thermal measuring and testing – Housing – support – or adjunct
Reexamination Certificate
1998-08-25
2001-05-29
Gutierrez, Diego (Department: 2859)
Thermal measuring and testing
Housing, support, or adjunct
C374S130000, C374S121000
Reexamination Certificate
active
06238089
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a probe tip for electronic thermometers. More specifically, the present invention relates to a removable titanium probe tip for tympanic thermometers. Even more specifically, the present invention relates to a removable titanium probe tip for tympanic thermometers that includes a watertight seal and related method of construction thereof.
PRIOR ART
The diagnosis and treatment of many body ailments depends upon an accurate reading of the internal or core temperature of a patient's body, and in some instances, upon a comparison to a previous body temperature reading. For many years, the most common way of taking a patient's temperature involved utilization of Mercury thermometers. However, such thermometers are susceptible to breaking and must be inserted and maintained in the rectum or mouth for several minutes, often causing discomfort to the patient.
Because of the drawbacks of conventional Mercury thermometers, electronic thermometers were developed and are now in widespread use. Typically, such electronic thermometers have a probe connected by wires to a remote unit containing electronic circuitry. The probe is sheathed in a protective, disposable cover before being inserted into a patient's mouth or rectum. Using predictive techniques, the patient's temperature reading is taken in a significantly shorter time period, for example thirty seconds, compared to several minutes required for conventional Mercury thermometers. Also, the electronic thermometers in some instances provide more accurate temperature readings than Mercury thermometers.
Although electronic thermometers provide relatively more accurate temperature readings than Mercury thermometers, they nevertheless share many of the same drawbacks. For example, even though electronic thermometers provide faster readings, a half minute must still pass before an accurate reading can be taken. Finally, electronic thermometers must still be inserted into the patient's mouth or rectum.
Tympanic thermometers provide nearly instantaneous and accurate reading of core temperature without the undue delay attendant with other thermometers. The tympanic membrane is generally considered by the medical community to be superior to oral, rectal or axillary sites for taking a patient's temperature. This is because the tympanic membrane is more representative of the body's internal or core temperature and more responsive to changes in core temperature. Tympanic thermometers, those thermometers that sense the infrared emissions from the tympanic membrane, offer significant advantages over Mercury or conventional electronic thermometers.
Recent efforts to provide a method and apparatus for measuring body temperature inside the tympanic membrane have produced several excellent tympanic thermometers. For example, U.S. Pat. Nos. 4,602,642 and 4,790,324 to O'Hara et al provide for a tympanic thermometer that measures internal body temperature utilizing the infrared emissions from within the tympanic membrane of the ear, and are herein incorporated by reference in their entirety.
The tympanic thermometer of O'Hara is comprised of a probe unit that has a handle and a probe head body terminating in a probe tip which is inserted into the external ear canal. The handle houses a circuit board that controls the operation of the thermometer and a display that displays temperature readings and other information.
The probe head body is attached to the distal end of the circuit board and houses a seal assembly, optical waveguide tube, infrared filter and thermopile detector. The probe head body further includes a first bore in fluid flow communication with a narrower second bore. The distal end of the first bore forms a tip with an opening thereto for passing infrared emissions from the tympanic membrane into the probe head body. The infrared filter is mounted in the opening and filters unwanted emissions while the optical waveguide tube conducts the infrared emissions to the thermopile detector located at the proximal end of the tube. In order to prevent contamination from entering the probe head body, a seal assembly is also provided that furnishes a watertight barrier against liquid and debris from entering through the interface between the probe tip and the infrared filter.
Before the thermometer is inserted, the metal thermopile located inside the first bore is heated to a predetermined precise temperature by resistors which are energized and controlled through the circuit board. By heating the thermopile, the thermopile is thereby calibrated to a temperature near the core body temperature and higher reading accuracy is attained. The user then operates the thermometer by inserting the probe tip into the patient's ear canal and depressing the SCAN switch once the probe tip is properly seated inside the ear canal. At this point, infrared emissions from the tympanic membrane are filtered through the infrared filter and conducted by the optical waveguide tube until detected by the thermopile detector. Actuating the SCAN switch also alerts the microcomputer that the tympanic algorithm should commence. Once the microcomputer is alerted, it starts acquiring the thermopile output level at a rate of approximately seven times per second and stores and the maximum reading.
The accuracy of any temperature reading taken by a tympanic thermometer depends a lot on preventing liquid and debris from entering the probe head body and contaminating the optical waveguide tube, thereby requiring recalibration of the tympanic thermometer. Accordingly, a seal is required in order to seal off parts of the probe head body susceptible to entry by contaminants.
U.S. Pat. No. 5,293,877 ('877 patent) to O'Hara et al discloses a probe that includes a seal for preventing fluid and debris from contaminating the probe's front end. The probe seal recited in the '877 patent relies on the mechanical fit between the tube, IR filter and the probe tip to provide a dust-proof seal. The seal functions to isolate the probe from contaminants that might enter through the probe tip by seating the infrared filter against the lip of the probe tip opening and utilizing the tube stabilizer located at the distal end of the tube to press against the IR filter, thereby creating a seal about the probe head body. During manufacturing, the seal is formed by applying a predetermined compressive force to the proximal end of tube which compresses the tube against the IR filter seated against the probe tip opening, thereby sealing off the probe head body from dust or other contaminants.
However, the seal configuration and the probe tip of the '877 patent has several drawbacks. One drawback is that mating surfaces of the tube, IR filter and probe tip cannot be manufactured perfectly flat, therefore fluid is able to seep through these interfaces and possibly compromise the watertight integrity of the probe head body whenever the thermometer is cleaned with fluid cleaners. Another drawback with the '877 patent is that the probe tip, which is integral to the probe head body, is made of hard plastic and is susceptible to deformation when dropped. Such deformation of the tip may change the field of view of the probe and take the device out of calibration, thus requiring the probe head body to be replaced and the thermometer to be recalibrated.
As of yet, nothing in the prior art has addressed the problem of developing a watertight seal, preferably in conjunction with a strengthened removable probe tip that does not suffer from the particular drawbacks cited in the aforementioned system.
Therefore, there exists a need in the medical art for an improved watertight seal configuration for tympanic thermometers probes which can include a removable hardened probe tip if desired.
SUMMARY OF THE INVENTION
In brief summary, the present invention relates to an improved watertight seal for tympanic thermometers and related method of construction thereof which may also include a removable
Davis Mark A.
Korff John J.
O'Hara Gary J.
Schweitzer, Jr. Frederick F.
Vodzak John
Brown Rudnick Freed & Gesmer
De Jesus Lydia M.
Gutierrez Diego
Leonardo Mark S.
Sherwood Services AG
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