The Bioprobe

The bioprobe is an electrical device for tissue diagnosis of the cervix. The invention consists of a set of electrodes which directly contact the cervix, stimulate it with low voltage electrical signals, and measure the response. This response is used to analyze and classify the tissue on a detailed basis over the entire cervix. The bioprobe disposable tip is similar in shape to cryotips which are used to destroy abnormal cervical tissue by freezing

the contacted tissue.  The bioprobe will be positioned in the cervical canal like a cryotip and will then be moved under precise stepper motor control to make contact over the entire surface of the cervix. Several patentable features of this device solve problems in present screening techniques. One great advantage of the bioprobe over the Pap test is that the bioprobe uses electrical measurements to provide signals to the operator that proper contact has been made. This feature of the device remedies weaknesses of the Pap test by providing immediate feedback to guide the examiner in sampling the cervix completely, including the cervical canal. The benefit in contacting the cervix in such a controlled manner is that the cervix is not only sampled comprehensively and a map of the cervix obtained, but that the information from neighboring tissue on the surface and below the surface can be used

to refine the analysis of tissue at a sampling point.

The electrical data will be presented to the operator in a color-enhanced screen display which is easily understood. The bioprobe will control the depth of tissue which is probed. Since the abnormal tissue originally appears below the surface and develops outward, the depth information will provide early detection of changes in the cervix and better diagnose the state of the tissue. The tissue maps will be stored for each patient and can later be referenced to monitor the progress of suspect tissue as it undergoes normal repair or progresses to a state where intervention is indicated.

The fine graphic detail of the display will provide evidence both to the doctor and the patient that the exam has been thorough. It will also encourage the patient to repeat the exam on a regular basis. Patients who have a continuing relationship with a personal physician, studies show, have greater survival rates and lower health costs. The bioprobe system concentrates information at the place of the primary physician rather than by referral. The system allows the practitioner to use an expert system inexpensively. Diagnostic workup will be reduced and surgical intervention will be minimized. The actual time of the examination using the bioprobe will less than one minute.