Medical systems, devices and methods adapted for tissue fixation and approximating tissue defects

A medical system configured to close a soft tissue defect within a patient's body cavity, the system comprising:

• a medical device comprising:
• an elongate body having a strap at a proximal end, and
• a first lock-head disposed at the proximal end of the strap, the first lock-head having an aperture for receiving a distal end of the strap, the aperture configured for permitting at least one controlled translation of the strap in a first direction through the first lock-head and restricting motion in a second direction opposite the first direction, wherein the controlled translation comprises a tightening of the strap;
• a suture passer comprising a proximal handle, a shaft and a grasping tip at a distal end of the shaft, and comprising an actuation knob on the proximal handle in operative communication with the grasping tip and configured to open and close the grasping tip;
• a crossing guide comprising a shaft and an eyelet at a distal end of the shaft;
• a tensioner and cutter comprising:
• a lumen therethrough,
• a second lock-head disposed within the lumen, which engages at least a portion of the elongate body;
• a threading tool removably disposed within the lumen of the tensioner and cutter, the threading tool comprising a distal end for attaching to the distal end of the medical device and a proximal end extending outwardly from the lumen of the tensioner and cutter configured for pulling the threading tool and attached distal end of the medical device through the lumen of the tensioner and cutter and through the second lock-head of the tensioner and cutter;
• and
• a blade arranged within a distal portion of the lumen of the tensioner and cutter, the lumen configured to receive at least a portion of the elongate body therethrough for successive translational tightening of the strap through the second lock-head of the tensioner and cutter, the blade configured for cutting an excess length of the elongate body when tightening of the strap is complete.

A method for serially and sequentially approximating and closing a series of spaced-apart straps to close a tissue defect in a body, the method comprising:

• providing a first system for sequential tightening of a surgical strap, the first system having a first tensioner and cutter with a first lock-head and a blade, a first threading tool, and a first surgical strap having a lock-head;
• feeding a distal end of the first surgical strap into the body and through the lock-head of the first surgical strap, wherein the first surgical strap is disposed around the tissue defect;
• grasping the distal end of the first surgical strap with the first threading tool;
• pulling the distal end of the first surgical strap through a lumen of the first tensioner and cutter and through the first lock-head of the first tensioner and cutter to apply at least some tension to the first surgical strap and wherein the first surgical strap is held inside the first tensioner and cutter and under tension, and wherein the first lock-head is positioned within the lumen of the first tensioner and cutter;
• providing a second system for sequential tightening of straps having a second tensioner and cutter with a second lock-head and a blade, a second threading tool, and a second surgical strap;
• feeding a distal end of the second surgical strap into the body and through the lock-head of the second surgical strap, wherein the second surgical strap is disposed around the tissue defect;
• grasping the distal end of the second surgical strap with the second threading tool;
• pulling the distal end of the second surgical strap through a lumen of the second tensioner and cutter and through the second lock-head of the second tensioner and cutter to apply at least some tension to the second surgical strap and wherein the second surgical strap is held inside the second tensioner and cutter and under tension, and wherein the second lock-head is positioned within the first tensioner and cutter,
• wherein the first and second surgical straps are spaced apart from each other when disposed around the tissue defect;
• and
• sequentially begin approximating the tissue defect by:
• translating the first surgical strap through the first lock-head of the first tensioner and cutter, and then translating the second surgical strap through the second lock-head of the second tensioner and cutter.

A method for serial tightening a series of spaced-apart straps to close a tissue defect in a body, the method comprising:

• providing a first system for sequential tightening of surgical straps, the first system having a first surgical strap and a threading tool, the first surgical strap comprising a leader at a distal end, an elongate body at a proximal end, and a transition section between the elongate body and the leader, wherein the leader has a lower bending stiffness than the elongate body, and wherein the leader is a mesh or a suture, the elongate body comprising a lock-head, and a first threading tool disposed through the lock-head of the first surgical strap;
• feeding the leader of the first surgical strap into the body and grasping the leader of the first surgical strap with the first threading tool;
• pulling the first threading tool and the leader of the first surgical strap through the lock-head of the first surgical strap, wherein the first surgical strap is disposed around the tissue defect;
• applying at least some tension to the first surgical strap;
• providing a second system for sequential tightening of surgical straps, the second system having a second surgical strap and a threading tool, the first surgical strap comprising a leader at a distal end, an elongate body at a proximal end, and a transition section between the elongate body and the leader, wherein the leader has a lower bending stiffness than the elongate body, and wherein the leader is a mesh or a suture, the elongate body comprising a lock-head, and the second threading tool disposed through the lock-head of the second surgical strap;
• feeding the leader of the second surgical strap into the body and grasping the leader of the second surgical strap with the second threading tool;
• pulling the second threading tool and the leader of the second surgical strap through the lock-head of the second surgical strap, wherein the second surgical strap is disposed around the tissue defect;
• applying at least some tension to the second surgical strap;
• wherein the first and second surgical straps are spaced apart from each other when disposed around the tissue defect;
• and
• sequentially begin approximating the tissue defect by:
• translating the first surgical strap through the lock-head of the first surgical strap, and then translating the second surgical strap through the lock-head of the second surgical strap.