Surgery – Diagnostic testing – Measuring anatomical characteristic or force applied to or...
Reexamination Certificate
2002-10-09
2004-08-17
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring anatomical characteristic or force applied to or...
Reexamination Certificate
active
06776766
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates in general to a method and apparatus for characterizing gastrointestinal sounds and in particular to a method and apparatus employing a microphone array attachable to a patient's body for collecting sounds from multiple sources in the body and a computer system for receiving digitized gastrointestinal sound signals and determining the spectra and duration of the sounds and characterizing states of the gastrointestinal tract on the basis of the spectrum and duration.
It has been known in the past to employ electronic analysis of sounds from the gastrointestinal tract as an adjunct to the physician auscultating the gastrointestinal tract in an attempt to determine quickly and with a minimum of diagnostic equipment the condition of the patient. In the past, for instance, as disclosed in U.S. Pat. No. 5,301,679, a method and system was provided for providing diagnostic information for various diseases including diseases of the gastrointestinal tract by capturing body sounds in a microphone placed on the body surface or inserted orally or rectally into the gastrointestinal tract. The spectrum analyzer used a real time audio one-third octave technique using a plurality of analog filters and a peak detector provide a log calculation of envelope amplitudes. Other systems also used microphones sensitive to specific frequency ranges and are exemplified by Dalle, et al. “Computer Analysis In Bowel Sounds,”
Computers in Biology and Medicine
February 1975 4(3-4) pp. 247-254; Sugrue et al., “Computerized Phonoenterography: The Clinical Investigation of the New System,” Journal of
Clinical Gastroenterology
, Vol. 18, No. 2, 1994, pp. 139-144; Poynard, et al., “Qu'attendre des systemes experts pour le diagnostic des troubles fonctionnes intestinaux,”
Gastroenterology Clinical Biology
, 1990, pp. 45C-48C. Also of interest are U.S. Pat. Nos. 1,165,417; 5,010,889; 4,991,581; 4,792,145. Unfortunately, none of the systems relate to using specific morphological filtering and event characterization of the type which might be able to identify ileus or small bowel obstruction or the like. The prior systems seem to have suffered from the inability to cope with relatively irregular sounds and irregular signals and to pick events of detail from the signal. Many of the systems used averaging techniques on the raw signal, which would tend to obscure the event of interest in noise or other unwanted portions of the signal and thus actually work against the diagnostician attempting to characterize genuine gastrointestinal sounds as opposed to other sounds coming form the body. Thus, it would appear that despite the use of sophisticated spectral techniques and the like the prior art, having been unable to identify events, appeared to operate on relatively noisy data from which it would be difficult to extract meaningful conclusions. Accordingly, what is needed is a system which can quickly and easily identify such conditions.
SUMMARY OF THE INVENTION
The invention is directed to a method and apparatus including a microphone array including three microphones fixed on a mount for precise positioning with respect to key location of the anatomy of the patient with a fourth free microphone which may be placed adjacent to the sternum of the patient for picking up breathing, cardiac and environmental sounds and the like which are to be subtracted from the gastrointestinal sounds and are treated as noise. The microphones feed a sound equalizing system for selection of certain sound frequency ranges which in turn feeds analog sound signals representative of gastrointestinal sounds to a tape recorder. The tape recorder is connectable to a computer which includes an analog to digital converter. Digitized multiple gastrointestinal sounds may then be processed by a computer in accordance with morphological filtering algorithms which characterize both the spectra and the duration of the sounds emanating from the gastrointestinal tract. In addition, the computer can subtract out components of sounds related to the background noise from the surrounding room or from the breathing which is picked up by a free microphone. An output indication may be provided to the physician or other health care worker through a printer or a video display screen which provides an indication as to the type of sound and a characterization in some cases as to the condition of the patient such as ileus and the like.
The present system is particularly characterized by the fact that the initial processing of the digitized audio signals relates to selecting gastrointestinal events of interest from extended noisy audio signals. One way in which this has been done in the present application is to use an amplitude thresholding system to look for events of interest and then to focus additional processing on those events. This approach does not appear to have been taken in the previous systems and may have reduced their ability to extract meaningful data from the relatively noisy environments in which they operate.
Approximately ten percent of the U.S. population has gastrointestinal symptoms each year for which physician consultation is sought. The symptoms include abdominal pain, distension, diarrhea and vomiting. The causes vary from benign conditions such as irritable bowel syndrome or self-limiting viral illness to life-threatening bowel blockage. Current diagnostic methods for determining what is occurring include a host of expensive and invasive tests, including such techniques as CT scans and colonoscopy.
The instant invention provides utility for diagnostic data for conditions involving small bowel obstruction, delayed gastric emptying, inflammatory disorders and motility disorders. For instance, small bowel obstruction, which includes various types of mechanical bowel obstruction, is a common reason for emergency surgical admission to the hospital and results in over 9,000 deaths each year. Signs and symptoms of small bowel obstruction may mimic benign viral or other illnesses. Many patients, especially medically complex subjects also having cancer, diabetes, previous gastrointestinal surgery and sepsis may present diagnostic dilemma of small bowel obstruction versus non-mechanical pseudo-obstruction or ileus. It is critical to distinguish these patients promptly since small bowel obstruction patients typically require surgical intervention while ileus patients are usually managed without surgery. Delay in proper diagnosis may lead to improper and dangerous surgical intervention in the non-obstructive patient or, conversely, may lead to complications or death in those with bowel obstruction. The instant invention provides a rapid, safe, accurate, low cost, lightweight and comfortable apparatus for assisting in small bowel diagnosis.
In addition, the apparatus can determine conditions involving delayed emptying of gastric contents, a condition called gastroparesis, to which millions are subject. Symptoms of gastroparesis include bloating, heartburn, belching, decreased appetite and upper abdominal pain. The preferred diagnosis method is scintigraphy scanning, whereby a liquid or solid meal is labeled with a gamma ray emitting radioisotope, usually radioactive technetium, and counts are obtained using a gamma camera over a period of 60 to 120 minutes. The test is expensive and requires special scheduling.
Inflammatory disorders are the most common of all gastrointestinal disorders and include peptic ulcer disease, viral, bacterial and other infections and the inflammatory bowels disease such as Crohn's disease and ulcerative colitis. Inflammatory changes of the gastrointestinal tract lead to altered mechanical properties including changes in acoustic resonance and reflective characteristics. The instant invention, through the use of its sophisticated signal processing, provides pattern recognition techniques for examining patients for inflammatory disorders.
Motility disorders are a diverse set of less well-defined conditions that pertain to derangement in the control and function
Mansy Hussein A.
Sandler Richard H.
Fitch Even Tabin & Flannery
Rush-Presbyterian-St. Luke's Medical Center
Szmal Brian
Winakur Eric F.
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