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
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12262887-B2
Publication Date
2025-04-01
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 relates to a knotless, clampless medical fixation system configured to close a soft tissue defect using an elongate body having a strap at a proximal end and a leader at a distal end joined by a transition section. A proximal lock-head is disposed at the proximal end of the strap and includes an aperture for receiving the distal end of the strap, where the aperture is configured to permit at least one controlled translation of the strap in one direction through the lock-head while restricting motion in the opposite direction, the controlled translation comprising a tightening of the strap.
The leader has a lower bending stiffness than the strap and comprises a different material than the strap. The transition section joins the strap to the leader, and the stiffness of the transition section gradually decreases from the strap to the leader, providing a stiffness gradient between the strap and the more flexible leader.
In some embodiments, the leader comprises a mesh, and additional implementations include adding a stiffening element inside a lumen of at least a portion of the leader, with the leader still maintaining a lower bending stiffness than the strap and the lock-head continuing to enable controlled one-direction tightening of the strap without reverse motion.
Claims Coverage
The provided independent claims are clm-00001, clm-00027, clm-00031, and clm-00032. Across these independent claims, the core inventive features consistently cover a strap/leader construct with a transition section stiffness gradient and a proximal lock-head that enables controlled one-direction tightening of the strap while restricting opposite-direction motion, with additional independent-claim variations specifying mesh or elastomeric/tubular strap configurations and an internal stiffening element inside the leader lumen.
Strap/leader transition section stiffness gradient with one-way controlled tightening
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, wherein the leader has a lower bending stiffness than the strap, and wherein the stiffness of the transition section gradually decreases from the strap to the leader; and 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.
Leader material distinct from strap with mesh leader
The leader comprises a different material than the strap and the leader comprises a mesh, with the transition section stiffness gradually decreasing from the strap to the leader, and the proximal lock-head configured for 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.
Stiffening element inside leader lumen
A stiffening element inside a lumen of at least a portion of the leader, wherein the leader has a lower bending stiffness than the strap, the leader comprises a different material than the strap, and the stiffness of the transition section gradually decreases from the strap to the leader; and a lock-head disposed at the proximal end of the strap configured for 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.
Elastomeric strap with lower-bending-stiffness leader and gradual transition stiffness decrease
At least a portion of the strap comprises an elastomeric material, wherein the leader has a lower bending stiffness than the strap, wherein the leader comprises a different material than the strap, wherein the stiffness of the transition section gradually decreases from the strap to the leader; and a lock-head disposed at the proximal end of the strap having an aperture for receiving the distal end of the strap, 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.
Tubular structure strap with lower-bending-stiffness leader and gradual transition stiffness decrease
At least a portion of the strap comprises a tubular structure, wherein the leader has a lower bending stiffness than the strap, wherein the leader comprises a different material than the strap, wherein the stiffness of the transition section gradually decreases from the strap to the leader; and a lock-head disposed at the proximal end of the strap having an aperture for receiving the distal end of the strap, 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.
Across clm-00001, clm-00027, clm-00031, and clm-00032, the claim coverage centers on a strap/leader closure device with a transition section that gradually decreases stiffness from the strap to the leader, where the leader has lower bending stiffness and is made of a different material than the strap. Each independent claim also includes a proximal lock-head whose aperture enables controlled translation of the strap in one direction for tightening while restricting motion in the opposite direction, with additional independent claim scope specifying mesh leadership, inclusion of a stiffening element inside a leader lumen, elastomeric strap material, or tubular strap structure.
Stated Advantages
Knotless tightening of the strap using controlled translation through a lock-head while restricting reverse motion.
Clampless tightening of the strap, avoiding knots and clamps (as described in the provided claim refinement summary).
A stiffness gradient via a transition section with stiffness gradually decreasing from the strap to the leader.
Reduced bending stiffness mismatch by defining the leader to have a lower bending stiffness than the strap.
Documented Applications
Closing a soft tissue defect.
Ventral hernia repair, including procedural context described for ventral hernias.
Interested in licensing this patent?