Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2000-03-22
2002-08-27
Smith, Ruth S. (Department: 3737)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S316000, C600S319000, C600S407000, C600S473000, C600S476000, C128S899000
Reexamination Certificate
active
06442409
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to devices and methods for testing an animal for the existence of a biomedical condition and more particularly to a system for testing an animal for the existence of a biomedical condition, such as hyperglycemia, hypoglycemia or other disorders in the body, using radiant energy either emitted by an implanted vertical-cavity surface-emitting laser or reflected by a mirror.
BACKGROUND OF THE INVENTION
Many medical diagnostic techniques project radiant energy into the body of an animal for testing for the existence of a biomedical condition. For example, the integrity of the skeletal structure may be examined by passing X-rays through the body. The dense bony material substantially blocks the passage of the X-rays, permitting a doctor or other medical care provider to visually inspect for fractures or other defects in the skeletal structure.
X-rays are also used in mammography to detect tumors in the breast. In this technique, the X-rays are passed through the breast such that they do not travel through any bony structure. The X-rays are hindered by tumors in the breast which show up as dark spots on the X-ray film. Although under this technique tumors may be detected earlier than by physical examination, the technique is difficult to administer due to the angle that the X-rays must be passed through the breast.
To examine the soft tissue of the body, other techniques are available. These include, among others, CAT scans and magnetic resonance imaging. Both project radiant energy onto the body for obtaining information about the physical structure of the body. Although these techniques are highly accurate and provide detailed information, they are time consuming to administer and costly to perform.
Further, measurement of the level of certain chemicals or compositions within the body is a diagnostic test of particular interest. Radiant energy may be used in these applications as passage of the radiant energy through particular chemicals or compositions often alters the radiant energy in a manner that can be measured and analyzed. For example, the monitoring of the glucose level of the blood is of particular importance to diabetics. One method of measuring the person's glucose level involves projecting polarized radiation into the body and measuring the optical rotation of the radiation that passes through the body. This optical rotation corresponds to the concentration of the glucose within the body. To be effective, however, the radiation must be passed through a relatively thin area of the body. Thus, the technique is usually performed on a person's earlobes or fingers. However, the skin and other tissue through which the radiant energy passes can interfere with the accuracy of the test.
To overcome the inaccuracies associated with passing the radiant energy through the tissue, attempts have been made to project the radiant energy through the cornea and aqueous humor of the eye. This is done because the concentration of glucose, oxygen and other chemicals in the cornea and aqueous humor, for example, reflects the concentration generally throughout the body. However, several problems are associated with this technique as well. For example, in Quandt U.S. Pat. No. 3,963,019, radiant energy is projected into the eye and reflected off the iris. The reflected radiation is detected and the optical rotation caused by passage of the reflected radiation through the cornea and aqueous humor is determined. However, this method suffers from poor sensitivity, in part because it relies on reflecting the radiant energy off the iris. Other attempts, as shown in March U.S. Pat. No. 3,958,560 and March U.S. Pat. No. 4,014,321, project the radiant energy at a shallow angle into the cornea on one side of the eye, through the aqueous humor, and out the cornea on the opposing side of the eye. Although this test achieves high accuracy, it is difficult to administer because of the shallow angle at which the radiant energy must be passed through the eye. Furthermore, as shown in Peyman U.S. Pat. No. 5,560,356, the disclosure of which is herein incorporated by reference, radiant energy is reflected on a mirror implanted in the eye. This test is also relatively accurate, however, the beam of radiant energy must pass through the aqueous humor and/or cornea of the eye twice, once traveling through the aqueous humor and then reflected off the mirror and again through the aqueous humor out of the eye, each step, including the reflective step, deteriorating the beam of radiant energy and making measurement less accurate.
Thus, there has been a continuing need for a device and method for reliably and easily performing tests using radiant energy for detecting the existence of biomedical conditions. More particularly, there has been a continuing need for a device and method for reliably and easily measuring the level of a substance in the body using radiant energy.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide a system for use in testing for the existence of a biomedical condition using radiant energy that passes through the aqueous humor in the eye once, thereby resulting in a highly accurate measurement device.
Another object of the present invention is to provide a system for use in testing for the existence of a biomedical condition using radiant energy that is easily administered without compromising accuracy.
Still another object of the present invention is to provide a system for use in testing for the existence of a biomedical condition using radiant energy that utilizes a known focused wavelength of light emitted from within the body of a test subject, resulting in a highly sensitive and accurate measurement device.
Yet another object of the present invention is to provide a system for use in testing for the existence of a biomedical condition using radiant energy that repolarizes a light beam as it is reflected off a mirror.
The foregoing objects are basically obtained by providing a system for testing for the existence of a biomedical condition using radiant energy, the combination comprising a radiant energy source for projecting radiation into and through the tissue of a portion of an animal test subject, a light emitter for implantation in the body of the animal test subject for emitting a known wavelength of light through the body when activated by the projected radiation of the radiant energy source, a receiver including a detector positionable relative to the light emitter for detecting the known wavelength of light, and a processor in communication with the detector for calculating changes in the known wavelength of light after passage through the body of the animal test subject to determine the existence of a biomedical condition.
The foregoing objects are also obtained by providing a system for testing for the existence of a biomedical condition using radiant energy, the combination comprising an intraocular lens system having a lens portion and haptics for implantation in an eye of an animal test subject, a radiant energy source for projecting radiation into and through the cornea of the eye of the animal test subject, a reflective device configured and sized for implantation in the body of the animal test subject for reflecting the radiation out of the eye, a receiver including a detector for detecting the reflected radiation, and a processor in communication with the detector for calculating changes in the reflected radiation after passage through the body of the animal test subject to determine the existence of a biomedical condition.
REFERENCES:
patent: 3958560 (1976-05-01), March
patent: 3963019 (1976-06-01), Quandt
patent: 4014321 (1977-03-01), March
patent: 4878910 (1989-11-01), Koziol et al.
patent: 4949350 (1990-08-01), Jewell et al.
patent: 5560356 (1996-10-01), Peyman
patent: 5570697 (1996-11-01), Walker et al.
patent: 5754578 (1998-05-01), Jayaraman
patent: 5933444 (1999-08-01), Molva et al.
patent: 6253097 (2001-06-01), Aronow et al.
Goodman Alfred N.
Howell Jeffrey J.
Smith Ruth S.
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