Systems, devices and methods for tissue fixation and approximating tissue defects
Inventors
Kramer, Thomas A. • Chin, Albert K. • Borchers, Gannon • Bugos, Peter • Kwok, Andrew • Ledbetter, Steven
Assignees
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Publication Number
US-11793508-B2
Publication Date
2023-10-24
Expiration Date
Abstract
A medical device for approximating and securing tissue without requiring knots includes a lock-head, a strap section, distal protuberance, and a leader section. The device also includes a transition section between the leader and the strap section and a stiffening section proximal to the protuberance. The leader section is used to draw the strap section into the body through small apertures in tissue and the transition section provides a gradual transition in stiffness and size between the leader and the strap section.
Core Innovation
The invention provides a knotless, clampless soft-tissue closure system implemented as a medical device configured to close a soft tissue defect. The device includes an elongate body with a strap at a proximal end and a leader at a distal end, with a transition section joining the strap to the leader. The transition section is arranged such that its stiffness gradually decreases from the strap to the leader, and the leader has a lower bending stiffness than the strap.
The device further includes a distal portion of the leader that forms at least one loop, and a lock-head disposed at the proximal end of the strap. The lock-head includes an aperture for receiving the distal end of the strap, where the aperture permits controlled translation of the strap through the lock-head in one direction and restricts motion in the opposite direction. This controlled translation comprises tightening of the strap.
To enable incremental or serial tightening without knots or clamps, the device includes multiple strap locking feature designs. These designs can include teeth or ramped teeth with gaps/intermittent tooth sections, apertures in tissue with pawls/barbs/tines, and cam/lever or ball-and-wedge/clutch locking. The system supports atraumatic grasping and threading using leader/loop stiffening zones, and the disclosed examples are provided in a ventral hernia context with incremental closure using a plurality of self-locking straps.
Claims Coverage
The independent claim requires a medical device for closing a soft tissue defect with an elongate strap and leader connected by a transition section that provides graded stiffness, and a proximal lock-head that permits one-direction controlled translation to tighten the strap while restricting reverse motion. The inventive features are further narrowed by dependent claims that specify loop stiffness, stiffening elements and materials, aperture/strap geometry, and particular strap locking structures.
Soft-tissue closure using elongate strap and leader with a transition section
A medical device configured to close a soft tissue defect, the device comprising an elongate body having a strap at a proximal end, a leader at a distal end, and a transition section joining the strap to the leader.
Graded stiffness transition from strap to leader
The stiffness of the transition section gradually decreases from the strap to the leader; wherein the leader has a lower bending stiffness than the strap.
One-way lock-head permitting controlled translation for tightening
A lock-head disposed at the proximal end of the strap, the lock-head having an aperture for receiving the distal end of the strap, the aperture configured for permitting at least one controlled translation of the strap in one direction through the lock-head and restricting motion in the opposite direction, wherein the controlled translation comprises a tightening of the strap.
Looped distal leader portion
The leader comprises at least one loop formed from a distal portion of the leader.
Overall, the claim coverage centers on graded stiffness between strap and leader, combined with a proximal lock-head aperture that permits one-direction controlled translation to tighten the strap while restricting reverse motion, together with a leader loop formed from a distal portion.
Stated Advantages
Knotless soft-tissue closure.
Clampless soft-tissue closure.
Controlled tightening of the strap using controlled translation through the lock-head while restricting motion in the opposite direction.
Incremental closure using a plurality of self-locking straps.
Documented Applications
Ventral hernia procedure using incremental closure with a plurality of self-locking straps.
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