Suction evacuation sheath

A method for removing a stone, a stone fragment or a foreign body from a patient using a suction evacuation assembly comprising the steps of:

• providing a suction evacuation assembly which includes:
• a primary sheath which has a proximal end, a distal end and an outer surface wherein the distal end is flexible, allowing the distal end to be actively or passively deflected;
• a handle chamber located at the proximal end of the primary sheath, the handle chamber including a proximal end, a distal end, a lumen, an arresting wall and a color band which is located on the outer surface;
• an obturator which is inserted into the proximal end of the sheath and which extends beyond the distal end of the sheath and is releaseably secured to the sheath;
• a side arm emanating from the outer surface of the primary sheath, the side arm having a lumen which opens into the lumen of the primary sheath, an outer surface and a pressure regulating mechanism (PRA) in the form of a slit or hole which passes from the outer surface of the side arm through to the lumen of the side arm;
• wherein when minimum negative pressure is required, the PRA is left open or minimally occluded and when additional negative pressure is required, the PRA is further or completely occluded;
• a deflection mechanism secured to the primary sheath which is operationally associated with the flexible, distal end which will enable the user to adjust the direction of the distal end of the sheath to aid with the direction of suction, irrigation, instrument placement, or removal of a stone, stone fragment or any other foreign body or tissue from a patient;
• and
• a secondary sheath which has a proximal end, a distal end and an outer surface, designed to be inserted into the primary sheath, the secondary sheath has a dual lumen with an oblong shape wherein the dual lumen allows passage of surgical instruments and irrigation fluid and wherein the oblong shape provides for adequate space for the egress of stone fragments and fluid through the primary and/or secondary sheath;
• wherein the secondary sheath further includes an insertion handle with a proximal end and a distal end and wherein the insertion handle is inserted into the handle chamber until the proximal end engages the arresting wall of the handle chamber to stabilize the secondary sheath when engaged within the primary sheath;
• wherein the distal end is flexible, allowing the distal end to be actively or passively deflected and wherein the secondary sheath is longer than the primary sheath allowing the distal end of the secondary sheath to extend beyond the distal end of the primary sheath in order to allow irrigation, a catheter, a foreign body basket, a backstop, an instrument or device to be passed to or beyond a stone, a stone fragment or other foreign body during a procedure to remove them;
• inserting an obturator into the proximal end of the primary sheath which extends beyond the distal end of the primary sheath and releaseably securing the obturator to the sheath;
• inserting the distal end of the primary sheath into a patient's body containing one or more stones or foreign bodies;
• positioning the distal ends of the primary sheath and the obturator in a position in close proximity to the stones or foreign bodies;
• disengaging the obturator from the proximal end of the primary sheath and removing the obturator from the primary sheath;
• the insertion handle is inserted into the handle chamber until the proximal end engages the arresting wall of the handle chamber to stabilize the secondary sheath
• inserting the secondary sheath into the proximal end of the primary sheath and extending the distal end of the secondary sheath beyond the distal end of the primary sheath and inserting the insertion handle into the handle chamber until the proximal end engages the arresting wall of the handle chamber to stabilize the secondary sheath releaseably securing the secondary sheath to the primary sheath;
• connecting one end of a primary tube to the side arm and connecting the other end of the primary tube to a collection bottle;
• connecting one end of a secondary tube to the collection bottle and connecting the other end of the secondary tube to a negative pressure system;
• inserting a scope into either the primary sheath or the secondary sheath and into the patient;
• adjusting the direction of the deflectable tip of the distal end of the primary and secondary sheaths using the deflection mechanism;
• visualizing the stone or foreign body using the scope;
• activating the negative pressure system in order to remove the stone or foreign body from the cavity if a diameter of the stone or foreign body is narrower than an inside diameter of the sheath and the side arm, or
• performing a lithotripsy on the stone or the foreign body in order to create fragments with a decreased diameter which allow the passage of the fragments within the inside diameter of the sheath and the side arm;
• and
• collecting the stone, foreign body and/or fragments through the side arm in the collection bottle.