Autonomous Ingestible Probe for Diagnosis and Therapy of Gastrointestinal Lesions Using Fluorescent Molecules
The invention is a Fluoropill (FP) - a swallowable pill-sized capsule camera for internal viewing of the digestive system and for transmitting video data to a reception system located outside the patient's body. The capsule camera is designed to detect diseases of the gastrointestinal (GI) tract, such as malignant polyps, at the molecular level, and enable to treat it, as well as to provide fast and accurate information on therapeutic efficacy. This capability of detecting a disease at the molecular level is obtained by a method called fluorescence spectroscopy. Certain molecules, when illuminated by light of certain waveband, emit light at other specific wavebands and detected by the optical system of the capsule camera. The fluorescence signatures of these molecules are used by the Fluoropill to identify specific molecular structures, which are either constituents of the GI walls or fluorescent molecular probes introduced locally by the capsule itself or systemically by injection into the blood stream. A camera device, such as charge-coupled device (CCD), captures the images and transmits the data to a receiving system outside the body. A navigation device allows locating and confirming the Fluoropill's position in space and coordinates of the capsule, thereby locating abnormal cells in the intestinal tract. The capsule is equipped with magnetic coils for controlling the movement of the capsule, if necessary. The capsule is battery-less and the operation energy is supplied by radiofrequency wave charging a capacitor. The molecular camera capsule is equipped with containers for potential release of either the fluorescent probe compound or therapeutic drugs. It may also be possible to store harvested tissue samples. The quantity of drug or probe compound released is controlled by an internal injection system. The transportation of the drug/probe to the target tissue can controlled by an electric field induced by a set of electrodes. In addition, the loading and depth of penetration of the drug/probe into the tissue is controlled by very short electric pulses (less than 1/1000 sec) delivered by the electrodes. Fluoropill is equipped with a light source that can activate a therapeutic action of certain drugs released from the capsule, transported and loaded into the diseased tissue. This method of drug activation, using light of specific wavebands, can been considered a form of photodynamic therapy. Description (Set) Proposed Use (Set) Detection of gastrointestinal cancer: GI cancers (esophageal, stomach and colorectal) comprise about 25% of the total number of cancer cases. Combined publications of the National Cancer Institute and the International Agency for Research on Cancer indicate that out of 20,000,000 new cancer cases diagnosed worldwide in the year 2000, 945,000 were colorectal, 876,000 stomach and 412,000 esophageal. Two-thirds of the colorectal cancers and one-third of stomach cancers diagnosed were in developed countries. The 5-year survival rate from colorectal cancer is of the order of 50%, stomach - 25% and esophageal - 15%. These data indicate that the current number of persons with a history of GI cancer is greater than 4 million, with a majority having colorectal cancer (2.5 million). These people will undergo one or two follow-ups tests each year, usually by endoscopy and computerized tomography (CAT). Fluoropill is potent tool for detection of GI tumors as a first tier and flow-up diagnostic technology of GI cancer. Fluoropill as a screening tool for colon cancer: Screening aimed at detecting the malignant polyp at an early stage of the disease, resulting in a more successful treatment outcome than by surgery, chemotherapy and radiation, and with a reduced impact on the patient. Currently, endoscopy (e.g., sigmoidoscopy, colonoscopy) is the most common screening approach for colon cancer. According to the National Cancer Institute, every other person of 50-yr-age and older in the US undergo endoscopy for screening purposes every 5 to 10 years, culminating to about several millions of GI endoscopies per year in the US alone. Endoscopy, X-ray, CAT scan and MRI - all detect and localize malignant polyps by anatomic markers (size, shape, and location). Since advanced-stage cancers are difficult to treat effectively, it is important to detect the disease at its early stages. However, such early tumors are often difficult to detect as they occur in regions of transformed mucous on the surface of the GI tract, and are radiologically and endoscopically occult. Fluorescent imaging using the Fluoropill is a potent screening means for an early detection of malignant polyps. For example, flat adenoma - a precursor of invasive carcinoma can be identified by fluorescent imaging of certain molecules (e.g., collagen, NADH), but is invisible to white light endoscopy. The capability of the Fluoropill to treat tumor and assess the effect of treatment in a very early stage of the treatment further enhances the commercial potential of the Fluoropill in GI malignant diseases. Here, we focus on cancer diseases. However, the molecular imaging and treatment means afforded by the Fluoropill can be useful also for the care management of other GI diseases, such as Crohn�s disease, inflammatory bowel disease, motility disorders and undiagnosed bleeding.
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