Needle assembly for tissue manipulation

An apparatus for forming a tissue fold, comprising;

• a housing;
• an elongate pusher extending from a distal end of the housing;
• a tubular sheath having a flat lumen adapted to receive the elongate pusher therethrough and having a proximal end which is attached to the housing, the tubular sheath having a flexible distal region such that the tubular sheath has a first position in which the flexible dial region extends substantially along a longitudinal axis defined by the remainder of the tubular sheath and a second position in which the flexible distal region forms an arcuate shape relative to the longitudinal axis whereby a distal end of the tubular sheath is disposed at an angle relative to the longitudinal axis;
• a needle body disposed on a distal end of the sheath, the needle body having a second lumen therethrough in communication with the first lumen of the tubular sheath;
• at least one anchor positioned distally of the elongate pusher;
• and
• a tissue manipulation assembly comprising a first extension member and a second extension member configured to receive a tissue fold in a space located between said first and second extension members;
• wherein said needle body has a first position in which the needle body is located outside of the space between mid first and second extension members and a second position in which the needle body is located within the space between mid first and second extension members.

An apparatus for forming a tissue fold, comprising;

• a housing;
• an elongate pusher extending from a distal end of the housing;
• a tubular sheath having a first lumen adapted to receive the elongate, pusher therethrough and having a proximal end which is attached to the housing, the tubular sheath having a flexible distal region such that the tubular sheath has a first position in which the flexible distal region extends substantially along a longitudinal axis defined by the remainder of the tubular sheath and a second position in which the flexible distal region forms an arcuate shape relative to the longitudinal axis whereby a distal end of the tubular sheath is disposed at an angle relative to the longitudinal axis;
• a needle body disposed on a distal end of the sheath, the needle body having a second lumen therethrough in communication with the first lumen of the tubular sheath;
• at least one anchor positioned distally of the elongate pusher;
• a tissue manipulation assembly comprising a first jaw and a second jaw configured to receive a tissue fold in a space located between said first and second jaws;
• and
• a launch tube having a distal end that is pivotably attached to said first jaw, with said tubular sheath being slidably disposed within a launch tube lumen defined by said launch tube;
• wherein said needle body has a first position in which the needle body is located within said launch tube lumen and a second position in which the needle body extends out of the launch tube lumen.