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The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that is used for standard intestinal endoscopic visualization and has a compatible instrument channel as defined in the instructions for use)

The modified NaviAid™ ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine. The modified NaviAid™ ICVI Device comprises a disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the ICVI disposable is to facilitate advancement of a standard endoscope into the small intestine. The modified NaviAid™ ICVI disposable includes the ICVI Balloon and the ICVI inflation tube. The balloon is inflated by ambient air. Either the Air Supply Unit ("ASU") or Single Balloon Air Supply Unit ("SB ASU") may operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU. The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon. The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The ICVI disposable can be pulled back at any time during the procedure in order to allow use of therapy tools. The NaviAid™ ICVI disposable is intended for-single use, while the ASU and SB ASU are re-usable.

The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).

The modified NaviAid™ BGC is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small and large intestine. The modified NaviAid™ BGC system comprises a disposable balloon system and an Air Supply Unit ("ASU") or a Single Balloon - Air Supply Unit ("SB ASU") for inflating and deflating the balloon system. The role of the BGC disposable is to facilitate advancement of a standard endoscope into the small and large intestine. The NaviAid™ BGC disposable includes the BGC Balloon and the BGC inflation tube. The balloon is inflated by ambient air. The ASU or SB ASU operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU. The BGC balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the BGC inflation tube at its proximal side, outside the patient's body. When the BGC balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the BGC inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring BGC balloon. The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the BGC disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools. During the procedure the disposable can be removed from the instrument channel of the endoscope and a therapy tool may be inserted instead. The NaviAid™ BGC disposable is intended for single use, while the ASU and SB ASU are re-usable.

The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that has an instrument channel that is at least 3.7mm and is used for standard intestinal endoscopic visualization).

The NaviAid™ ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine. The NaviAid™ ICVI system comprises a disposable balloon system and an Air Supply Unit ("ASU") or a Single Balloon - Air Supply Unit ("SB ASU") for inflating and deflating the balloon system. The ICVI disposable includes the ICVI Balloon and the ICVI inflation tube. The balloon is inflated by ambient air. The ASU or SB ASU operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU. The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon. The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. though not simultaneously while the device is applied. The NaviAid™ ICVI disposable is intended for single use, while the ASU and SB ASU are re-usable.

The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).

The NaviAid™ BGC Disposable is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to ensure positioning of a standard endoscope during endoscopy of the large or small intestine (standard endoscope - i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ BGC system comprises a disposable balloon system and an Air Supply Unit for inflating and deflating the balloon system. The role of the BGC disposable is to facilitate advancement of a standard endoscope into the large and/or small intestine. The NaviAid™ BGC Disposable includes the BGC Balloon and the BGC inflation tube. The balloon is inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the balloon through a footpedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU. The BGC balloon can be advanced ahead of the endoscope tip or pulled back by pushing/pulling action on the BGC inflation tube at its proximal side, outside the patient's body. When the BGC balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the BGC inflation tube serves as a "guide wire" that leads the endoscope as it is pushed towards the anchoring BGC balloon.

The NaviAid ™ BGE device is an accessory to an endoscope and is intended to ensure complete positioning of a standard endoscope in the small intestine (i.e., an endoscope that is 10-13 mm in diameter and is used for standard intestinal endoscopic visualization).

The NaviAid™ BGE affords deep access into the small intestine, while maintaining all the advantages of an endoscopic procedure, such as back-and-forth navigation, stopping propagation if needed, real-time operation, video imaging, working channel including biopsy and treatment. The NaviAid™ Balloon Guided Endoscopy (BGE) system comprises an accessory kit containing the disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the Balloon Guided Endoscopy (BGE) disposable accessory kit is to facilitate advancement of a standard endoscope deeper into the small intestine. The NaviAid™ BGE system "upgrades" standard endoscopes to a double balloon endoscopy system. The NaviAid™ BGE accessory kit includes two balloons - the Guiding Balloon for Small Intestine ("GBS") and the Stabilizing Balloon ("SB"). Both balloons are inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the two balloons through two foot-pedals. Each balloon is connected to a dedicated tube that runs along the endoscope, and is connected at its proximal (user) end to the ASU. The balloon tubes are attached to the endoscope with clips and silicon bands. The NaviAid™ BGE accessory kit is mounted (deflated) on the tip of the endoscope, and is inserted with the endoscope into the gastrointestinal tract of the patient. The SB is the proximal balloon that is used to anchor the endoscope (near its tip) to the intestinal wall. The GBS is the distal balloon that can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the GBS inflation tube at its proximal side, outside the patient body. When the GBS balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip (now with a deflated balloon) is advanced, and the GBS inflation tube serves as a "guidewire" that leads the endoscope as it is pushed towards the GBS anchoring location. The sequence of inflation and deflation of the balloons enables "pleating the small intestine on to the endoscope" or forming a rail on which the endoscope can be guided and advanced towards the GBS anchoring location. The balloons and tubes do not compromise the endoscope's flexibility, although its field of view may be reduced by up to 8%. Additionally, the balloons do not significantly compromise the maneuverability of the endoscope's tip and do not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The NaviAid BGE accessory kit is disposable and intended for single use, while the ASU is re-usable.