Surgery – Diagnostic testing – Measuring anatomical characteristic or force applied to or...
Reexamination Certificate
1999-06-07
2001-02-13
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Measuring anatomical characteristic or force applied to or...
C600S300000, C128S903000, C128S904000, C340S573100
Reexamination Certificate
active
06186962
ABSTRACT:
INTRODUCTION
1. Technical Field
The field of this invention is diseases characterized by edema.
2. Background of the Invention
Edema is defined as the abnormal accumulation of fluid in connective tissue. Edema typically results from a combination of passive venous congestion and salt and water retention, and may be systemic or localized to a particular region of the body. Dependent edema, in which fluid accumulates in the tissues of the limbic extremities, e.g. ankle, foot and the like, is a physical manifestation of a number of different human disease conditions. Dependent edema first appears in the feet and ankles of the ambulatory patient, and in the posterior surface of the calves and skin overlying the sacrum in the bedridden patient. Disease conditions characterized by the presence of dependent edema include local venous or lymphatic obstruction, cirrhosis, hypoalbumenia, and congestive heart failure.
In congestive heart failure, the presence of edema in the lower extremities is a valuable diagnostic marker for the presence of the disease. In addition to serving as a marker for the presence of congestive heart failure, the progression of the edemic state can be monitored over time and the progression of the edemic state related to the progression of the disease.
One way of detecting the presence of edema is to determine fluid volume change of the patient. A number of different technologies have been developed to identify the volume change, and include those based on the use of water or air-filled cuffs, mercury strain gauge, fiber optic strain gauge, and airborne ultrasound. Such technologies have principally been employed to measure venous blood flow and to sense the volume pulsations created by the heart.
Another way of detecting the presence of edema is the “pitting” method. In this method, a physician's thumb or finger is pressed into the patient's skin next to a bony surface (e.g., tibia, fibula, or sacrum). When the physician's finger is withdrawn, an indentation persists for a short time. The depth of the “pit” is estimated and generally recorded in millimeters, although subjective grading systems (e.g. “+++”, etc.) have also been described. In general, the distribution of edema is also noted, as the amount of fluid is roughly proportional to the extent and the thickness of the pit.
Because dependent edema is a physical manifestation of a number of different disease conditions, the development of accurate methods for the detection of edema is of interest. Of particular interest is the development of methods which are sufficiently inexpensive and simple so as to be amenable to use in both conventional and out-patient health-care settings.
Relevant Literature
Scientific American Medicine (Dale & Freeman eds)1:II provides a review of congestive heart failure, physical manifestations and methods for the treatment thereof.
Lindahl & Omata, Med. Biol. Eng. Comput. (1995) 33:27-32 provide a description of methods of assessing edema.
Other references of note include U.S. Pat. Nos. 3,791,375; 3,890,958; 3,974,491; 4,144,749; 4,383,533; 5,052,405; 5,323,650; and 5, 385,069; as well as Swedborg, Scand. J. Rehab. Med. (1977) 9:131-135; Mridha & Odman, Scand. J. Rehab. Med. (1989)21:63-39; Mridha & Odman, Med. Biol. Eng. Comput. (1986) 24: 393-398; Kushner et al., Am. J. Clin. Nut. (1986) 44: 417-424; Breytenbach, Int. J. Oral Surg. Bozicevic & Reed Ref: ALE-4P (1978) 7:386-392; Davies et al., Med. Biol. Eng. Comput. (1971) 9:567-570; Lindhal et al., Med. Biol. Eng. Comput. (1991) 29: 591-597; Iwakura, Med. Biol. Eng. Comput. (1978) 16:429-436; and Starr, BPR (1980) 17:98-102.
SUMMARY OF THE INVENTION
Methods and devices for measuring the presence of and/or monitoring the progression of edema in a host are provided. In the subject methods, an extremity of a host is first contacted with a force sensor means comprising a planar surface and a probe element extendable therefrom. The probe element is then extended from the planar surface into the tissue of the extremity to produce a depression or pit. A plurality of force measurements are then taken over a period of time to obtain a force profile. The resultant force profile is then related to the presence or absence of edema in the patient. The subject methods find use in a variety of applications, particularly in the detection and management of cardiac associated diseases where edema serves as a symptom.
REFERENCES:
patent: 3791375 (1974-02-01), Pfeiffer
patent: 3850034 (1974-11-01), Tsuchiya et al.
patent: 3890958 (1975-06-01), Fister et al.
patent: 3974491 (1976-08-01), Sipe
patent: 4132224 (1979-01-01), Randolph
patent: 4144749 (1979-03-01), Whitmore
patent: 4159640 (1979-07-01), Leveque et al.
patent: 4383533 (1983-05-01), Bhagat et al.
patent: 4611487 (1986-09-01), Krenn et al.
patent: 4838275 (1989-06-01), Lee
patent: 4951671 (1990-08-01), Coan
patent: 5027828 (1991-07-01), Kovacevic et al.
patent: 5052405 (1991-10-01), Batchelder
patent: 5323650 (1994-06-01), Fullen et al.
patent: 5373730 (1994-12-01), Kovacevic
patent: 5385069 (1995-01-01), Johnson, Jr.
patent: 5433215 (1995-07-01), Athanasiou et al.
patent: 5551437 (1996-09-01), Lotscher
patent: 5590649 (1997-01-01), Caro et al.
patent: 5671750 (1997-09-01), Shinoda
Boland, R. et al., “Development and Evaluation of a Precision Forearm and Hand Volumeter and Measuring Cylinder,”J. Hand Ther(1996), vol. 9, No. 4:349-358.
Breytenbach, H.S., “Objective Measurement of Post-Operative Swelling,”Int. J. Oral Surg.(1978) vol. 7:386-392.
Dramaix, M. et al., “Serum Albumin Concentration, Arm Circumference, and Oedema and Subsequent Risk Of Dying In Children In Central Africa,”BMJ(1993) vol. 307:710-713.
Kushner, Robert F., et al., “Estimation of Total Body water By Bioelectrical Impedance Analysis1-3,”The American journal of Clinical Nutrition(1986) vol. 44:417-424.
Lindahl, O.A., et al., “Impression Technique for the Assessment of Oedema: Comparison With A New Tactile Sensor That Measures Physical Properties Of Tissue,”Med.&Biol. Eng.&Comput., (1995) vol. 33:27-32.
Miyazaki, S., et al., “Foot-Force Measuring Device For Clinical Assessment of Pathological Gait,”Med.&Biol. Eng.&Comput.(1978) vol. 16:429-436.
Mridha, M. et al., “Fluid Translocation Measurement,”Scand j Rehab Med(1989) vol. 21:63-69.
Mridha, M., et al., “Noninvasive Method For The Assessment of Subcutaneous Oedema,”Medical&Biological Engineering&Computing(1986) vol. 24:393-398.
-., “An Automatic Device For The Measurement of Oedema In The Feet Of Rats and Guinea Pigs,”Med.&Biol. Enging.(1971) vol. 9:567-570.
Starr, Thomas W., “A Computerized Device for the Volumetric Analysis of the Residual Limbs of Amputess,”Bulletin of Prosthetics Research BPR 10-33(1980) vol. 17, No. 1,:98-102.
Swedborg, Iwona, “Voluminmetric Estimation of the Degree of Lymphedema and its Therapy By Pneumatic Compression,”Scand J Rehab Med(1977) vol. 9:131-135.
Lloyd Lester John
Wyer Jorah
Alere Incorporated
Bozicevic Karl
Bozicevic Field & Francis LLP
Marmor II Charles
O'Connor Cary
LandOfFree
Method and device for detecting edema does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method and device for detecting edema, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method and device for detecting edema will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2576202