Method and device for use in the diagnosis of inflammatory state

Surgery – Diagnostic testing – Sampling nonliquid body material

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A61B 500

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active

061496065

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BRIEF SUMMARY
FIELD OF THE INVENTION

The present invention relates to a novel method in the diagnosis of inflammatory states in inner organs, such as the urogenital organs, for example the urinary tract, uterus and oviducts. The present invention further relates to a new device and method for collecting endogenous gaseous nitric oxide (NO), in inner organs, such as the urogenital organs, for example the urinary tract, uterus and oviducts.


DESCRIPTION OF THE BACKGROUND OF THE INVENTION

Inflammatory conditions of the urogenital organs, for example in the urinary bladder (cystitis) and in the urethra (urethritis) often give rise to subjective symptoms, such as general discomfort, but also clinical symptoms, including urgency, dysuria, stricture and enuresis. In many cases the underlying causes are difficult to diagnose objectively. Patients with urgency symptoms from the lower urinary tract are very common. These symptoms may be due to inflammatory diseases or non-inflammatory functional disorders, and bladder biopsies are often required to distinguish between the two groups of patients. Inflammatory conditions in the uterus and oviducts are likewise often difficult to diagnose. A distinction between salpingitis and appendicitis may sometimes be practically impossible without preforming a diagnostic laparotomy. It is also of great importance to be able to rule out the occurrence of bacterial or viral infections, tumours or other pathological conditions, which untreated could have very severe consequences. Traditionally the investigation of previously mentioned symptoms has been performed through chemical and microbiological analyses of urine and discharge from said areas, ocular inspection e.g. urethroscopy and laparoscopy, the previous two often together with biopsy, followed by cultivation and/or studying the sample under microscope. Characteristic for many of said methods is, that they are time consuming, often require hospitalization and cause considerable discomfort to the patient.


STATE OF THE ART

It is previously known that NO is excreted into the airway lumen and is increased in exhaled air of asthmatic patients (Alving, K. et al., Eur Resp J. 6 (1993) 1386-70). Nevertheless large concentrations of NO are normally present in the nasal airways, without being a positive indication of any abnormal state (Lundberg, J. O. N. et al., Eur Resp J, 7 (1994) 1501-04). The role and occurrence of NO in the human body is still not conclusively investigated and many theories, often more or less incompatible, are presented. Further, greatly increased concentrations of NO have been measured in luminal gas sampled from the colons in patients with active ulcerative colitis (Lundberg, J. O. N. et al., Lancet, 344 (1994) 1673-4). NO has been found to be a clinically relevant marker for inflammatory conditions in the intestines and a patent application (SE 9404161-3) concerning a method for diagnosing such conditions, based on this finding is currently pending. Another related patent application, filed by the present inventors, concerns the collection of endogenous NO in the upper airways of tracheostomized or intubated patients and re-administration of the same gas in the inhaled airflow provided by the ventilator (SE 9502442-8). Said application is currently pending.
Tonometry, i.e. the measurement of the pressure inside a organ, has also been adapted to the sampling of gases in the gastrointestinal tract. Using a commercially available apparatus known as a Tonomitor.RTM., CO.sub.2 can be sampled in the gastrointestinal tract. The Tonomitor.RTM. consists of a silicone balloon, permeable to gases but not to liquids, attached to a sampling tube. The device is inserted in the lumen of the gut and the balloon is filled with saline. Over time the pCO.sub.2 of saline infused into the balloon equilibrates with the pCO.sub.2 of fluid in its proximity. The pCO.sub.2 in the lumen equilibrates with the pCO.sub.2 in the superficial layers of the mucosa with which it is in contact. The pCO.sub.2 of saline aspirated from a Tonomitor.RTM. pr

REFERENCES:
Alving, K., et al., "Increased amount of nitric oxide in exhaled air of asthmatics"; Dialog Information Service; File 154; (1994) Dialog Access. No. 07832223.
Lundberg, J.O.N., et al., "Primarily nasal origin of exhaled nitric oxide and absence in Kartagener's syndrome"; Eur. Resp. J., 7 (1994) 1501-04.

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