Surgery – Diagnostic testing – Temperature detection
Reexamination Certificate
2000-11-09
2002-07-16
Shaver, Kevin (Department: 3736)
Surgery
Diagnostic testing
Temperature detection
C600S388000, C600S386000, C600S382000, C600S372000
Reexamination Certificate
active
06419636
ABSTRACT:
FIELD OF THE INVENTION
The present invention is in the field of biotechnology and specifically relates to the field of breast assessment and breast cancer screening in women.
BACKGROUND TO THE PRESENT INVENTION—THE RELATED ART
For well over twenty years, thermometric assessment of the human female breast surface has been under investigation as a tool in the armamentarium of those concerned with the detection and treatment of breast cancer.
GB 1,490,803 (expired) and U.S. Pat. No. 4,055,166 (expired), both granted to Simpson and Green and of substantially identical content, describe a garment which is a brassiere upon and within which is mounted a plurality of sensors for the purpose of measuring breast temperature over the menstrual cyde. They referred to a menstrual cycle of breast heat amounting to a variation in surface temperature of about 1° C. which is maximal about three days before the onset of menstruation. In the preamble, it is made clear that the intention is to detect the presence of actual cancers based on the observation that areas adjacent to a cancerous growth may be “slightly warmer (say 1 or 2° F.) than unaffected areas of the other breast” and that comparison of the 24 hour temperature variation (circadian variation) between normal and cancerous breasts have shown clear differences in time structure.
In a subsequently abandoned application publication number GB 2,203,250 A, Simpson again teaches a garment in the form of a brassiere with a miniaturized electronic heat measuring device which has a number of cup temperature sensors. In a further embodiment there is disclosed another brassiere “having a single sensor net of high thermal conductivity wire centered on the nipple and extending for a few centimeters around each nipple”.
In these disclosures Simpson and his colleagues make an important structural distinction between their brassiere device and the earlier breast surface measurements which had been made in hospital environments with sensors fixed on the skin. They taught the provision of a garment which would allow temperature measurements to be recorded over relatively long periods while the subject lives normally. They provide “apparatus for measuring surface temperatures at points in the region of the human body, including a garment having a plurality of temperature sensors located therein at spaced apart positions, and means for so storing signals representing output signals from the sensors that the relationship of each signal time of occurrence can be retrieved”.
In particular, they indicate a preference for the storage means to be mounted on the garment. According to claim 1 of U.S. Pat. No. 4,055,166, the garment and the means for storing signals are integral. In Claim 1 of GB 1,490,803, the apparatus includes a garment and Claim 4, as well as other various other dependent Claims, describes a brassiere which includes sampling and storage means being integral with the brassiere.
Simpson and Green make it clear that, in relation to measurements of temperature on the breasts, the garment may be a brassiere. They teach a brassiere for measuring surface temperatures of the breasts at predetermined points, including a plurality of temperature sensors positioned in each cup of the brassiere, the sampling and storage means being integral with the brassiere.
Their underlying contention is that “The circadian rhythm of breast temperature is regarded as a normal feature of the mammary tissue differentiation—a response possibly of a target organ to tides of hormones in the circulation (e.g., 24-h variations in prolactin; menstrual variations in oestrogen). Consequently alterations of the circadian rhythm characteristics occur in breast pathology of which cancer is one example. In this situation the rhythm is sometimes absent and often of altered level and phase. It follows that monitoring breast temperature rhythm over daily and perhaps monthly intervals will be valuable in detection and characterization of disease, e.g. cancer.” From this, and other statements in the specification, it is clear that these authors did not contemplate the application of their invention in the assessment of the future risk of developing cancer and that it was limited to detection of and characterizations of actual lesions.
The Simpson and Green patents teach a brassiere fitted with temperature sensors positioned at points where tumors have been shown to occur most frequently—at the one, two and three o'clock positions, over the nipple, and at the nine o'clock position on the left breast, and on the right breast there is a similar disposition of sensors over the upper outer quadrant, that is at nine, ten and eleven o'clock positions with a sensor over the nipple and one at the three o'clock position. They do contemplate different positioning of the sensors and that a different number may be deployed.
What is quite clear, however, is that their device, as described, is a garment fitted with temperature sensors and having means for storing signals from the sensors included with or integral with the garment. It is also quite clear from the detailed descriptions and claims that, when the apparatus is to be used on the human breast, the garment is to be a brassiere. They also clearly describe, in Claim 6 of each patent, the use of a heat shield to prevent outward heat flow through the sensor.
Simpson has since suggested that the device, which is the subject of the test described in the two patents, is subject to ‘noise’ and that this is due to other vasomotor phenomena. He has suggested that “The problem with the method is not the signal, but the noise from these sources.”
Sir James Young Simpson Memorial Lecture, J. R. Coll. Surg. Edinb
., 41, June 1996. He goes on to suggest that future developments could include Doppler ultrasonography applied to the internal mammary artery and volumetric analysis of the breast and its component tissue using magnetic resonance imaging.
In the source quoted above, Simpson makes it clear that his developments are nowadays directed at trying to predict, from temperature measurements, which breasts may develop cancer later.
Although Simpson and Green appear possibly to have been the first workers to make serious attempts at detecting breast cancer by observing breast surface temperatures, theirs is not the only work. Detectors for actual cancer lesions based on breast surface temperature are still being developed and this is somewhat surprising since most authorities believe that tumors large enough to find by this method are already likely to have progressed so far as to carry with them fatal consequences.
One example is BreastAssure™ made in the USA by HumaScan Inc of Cranford, N.J. The makers claim that this device is the subject of two US patents which expired on May 22
nd
1998 and a Canadian patent which expired on Aug. 24
th
1999; these are all believed to be to Z. L. Sagi. Financial literature on the company states the product “ . . . consists of a pair of mirror-image, non-invasive, lightweight, disposable soft pads, each of which has three wafer-thin segments containing columns of heat sensitive chemical sensor dots that change color from blue to pink reflecting an 8.5° temperature range from 90° to 98.5° F. When placed over a woman's breasts, inside her brassiere for a period of 15 minutes, the device registers skin temperature variations due to heat conducted from within the breast tissue to the surface of the skin. By comparing the mirror-image temperature differences between the two breasts registered by the device, the physician can objectively quantify if there is abnormal unilateral breast thermal activity, which is considered significant if there is a 2° F. or more temperature difference between each breast in the same mirror-image location. Based on clinical studies at major medical centers, the threshold tumor size that resulted in significant skin temperature differences detectable with the device was as small as 5 mm in size.” It may be worth noting that, according to some authorities, cancers of th
Jenkins Kevin
Young Colin Alfred
Young David Ernest
Marshall Gerstein & Borun.
Natnithithadha Navin
Shaver Kevin
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