Systems, devices, and methods for closing an abdominal wall defect
Inventors
Chin, Albert K • Kramer, Thomas A
Assignees
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Publication Number
US-11213284-B2
Publication Date
2022-01-04
Expiration Date
Abstract
Systems, devices and methods for closing a tissue defect comprise a subcutaneous guide that is placed transcutaneously between two skin access sites and a self-locking strap that may be advanced into the body through a first access site via a first needle and then passed to a second needle. The strap may be withdrawn with the second needle through a second access site to the outside of the body. The strap may be withdrawn from the first needle, leaving the strap placed through both access sites and across the defect. As the subcutaneous guide is withdrawn from the body it pulls the captured strap such that both ends of the strap protrude from the first access site, allowing the strap to be tightened around the defect.
Core Innovation
The disclosed invention relates to minimally invasive closing of a tissue defect using a self-locking strap and a locking mechanism that tightens the strap around the defect. A guide and needle arrangement positions and delivers the self-locking strap through one incision site and a second incision site while retaining the strap for subsequent tightening using a lock-head. The disclosure is directed to ventral/abdominal wall hernia repair and abdominal wall defect closure using subcutaneous tunneling and engagement of strap ends by needles and the lock-head.
The core system includes a first needle with a lumen for delivering the self-locking strap and a slot for removing the strap, together with a second needle having a hook for engaging and pulling the strap from the body through a second incision site. A guide has an aperture near its distal end that passes the second needle and retains the strap after the second needle is removed. After the guide is removed from the first incision, the lock-head is placed over the distal end of the self-locking strap and advanced down the strap to tighten the self-locking strap around the defect.
Further aspects of the invention define strap and locking structures and the in-body/lock-adjacent securing actions. The self-locking strap includes ramped teeth with opposing ramp directions and an aperture-capable detached lock-head having opposing pawls that engage the distal end and proximal end, and the strap geometry provides a wider minimum cross-sectional thickness. The disclosure also describes instruments and components including strap apertures configured to facilitate tissue ingrowth, and cutters for severing the strap adjacent to the lock-head, as well as a tensioning device and optional robotic/automation interfaces for controlled advancement and incremental tightening with tension measurement.
Claims Coverage
The independent claims cover a complete system for closing a tissue defect with a self-locking strap and lock-head, method variants of deploying the strap across a defect and tightening it with a lock-head, and a device and strap structure for tensioning and locking. The independent inventive features across the set include guide-aperture retention with first/second needles, lock-head placement and advancement to tighten the strap, subcutaneous guide tunneling and strap capture/retraction, incrementally tightening with a tensioner including a movable lock-head and tension gauge functionality, and a specific self-locking strap tooth/pawl and lock-head aperture architecture, plus dedicated cutter and/or linear/rotational cutter structures.
Needle-delivered self-locking strap with guide aperture retention and first needle slot
A system for closing a tissue defect using a self-locking strap having a lock-head, a first needle having a lumen for delivering the self-locking strap through a first incision site, a second needle having a hook on its distal end for engaging the self-locking strap and pulling the strap through a second incision site, and a guide having an aperture near its distal end for passing the second needle therethrough and retaining the strap after the second needle is removed from the aperture, wherein the first needle includes a slot along its length for removing the self-locking strap.
Two-incision guide positioning and lock-head advancement to tighten
A method for closing a tissue defect comprising positioning a guide beneath the skin between a first incision and a second incision so the distal end of the guide resides near the second incision; inserting a first needle through the first incision; inserting a second needle through the second incision and through an aperture placing a distal end of a self-locking strap through the first needle and into the guide; engaging the second needle with the distal end of the strap; pulling the second needle through the guide and out of the body leaving the strap captured by the aperture in the guide; releasing the strap from the first needle; pulling the guide out of the body through the first incision so the distal end of the self-locking strap exits the first incision; and placing a lock-head over the distal end of the self-locking strap and advancing the lock-head head down the self-locking strap to tighten the self-locking strap around a defect.
Subcutaneous strap tunneling across a defect with lock-head engagement
A method for closing a tissue defect comprising inserting a first needle through a first incision and into a body cavity on a first side of a defect; placing the distal end of a self-locking strap through the first needle and into the body cavity; retracting the first needle from the body; removing the first needle from the strap while leaving the strap inside of the body; placing a guide through a second incision site on the opposite side of the defect and advancing the guide subcutaneously to the first incision site; engaging the proximal end of the strap with the guide and pulling the proximal end of the strap subcutaneously across the defect to the second incision site; placing a second needle through a lock-head attached to the proximal end of the strap and advancing the needle into the body cavity to engage the distal end of the strap; pulling the distal end of the strap out through muscle tissue and through the lock-head with the second needle; and tightening the strap to approximate the defect.
Needle, guide and hook-based strap retrieval with linear cutter structure
A system for closing a tissue defect comprising a self-locking strap having a lock-head at its proximal end; a first needle having a lumen for delivering the distal end of the self-locking strap through a first incision site; a guide for tunneling through subcutaneous tissue from the first incision site to a second incision site, the guide having a hook near its distal end for engaging with the self-locking strap and pulling the strap back through the subcutaneous tissue to the first incision site; a second needle having a hook at its distal end, the second needle being capable of passing through the lock-head and engaging with the distal end of the self-locking strap and pulling the distal end of the strap through the lock-head and out of the body; and a linear cutter having an inner tube with a lumen, an outer tube, and a radially flexing cutter that depresses into the lumen of the inner tube when forced by the outer tube.
Tensioning device with aligned stationary and movable lock-heads and tube abutment
A device for tensioning a self-locking strap comprising a shaft; a plunger slidably disposed on the shaft; a stationary lock-head distal to the plunger and affixed to the shaft; a movable lock-head affixed to the plunger and aligned with the stationary lock-head wherein the movable lock-head and the stationary lock-head are configured to allow a strap to pass through each lock-head; a frame slidably attached to the shaft and located distal to the stationary lock-head; a compression spring compressed between the frame and the stationary lock-head; and an elongate tube extending distally from the frame, the tube configured to abut against the lock-head of a self-locking strap inside of a human body.
Self-locking strap with opposing ramped teeth, detachable lock-head and wider minimum cross-sectional thickness
A self-locking strap comprising an elongate body having a distal end, a proximal end, a top side and a bottom side; a first set of ramped teeth on the top side; a second set of ramped teeth on the top side having a ramp direction in the opposite direction to the first set of teeth; a third set of ramped teeth on the bottom side having a ramp direction in the same direction as the first set of teeth; a fourth set of ramped teeth on the bottom side having a ramp direction in the same direction as the second set of teeth; a detached lock-head having an aperture capable of passing the distal end and proximal end simultaneously; wherein the lock-head has a set of opposing pawls protruding into the aperture for engaging with the distal end and the proximal end; and wherein the third set of ramped teeth are offset longitudinally from the first set of ramped teeth and the fourth set of ramped teeth are offset longitudinally from the second set of ramped teeth, to provide a wider minimum cross-sectional thickness to the strap.
Across the independent claims, the coverage centers on closing a tissue defect using a self-locking strap and a lock-head architecture, where needles and a guide position and retain strap ends for subsequent lock-head placement and strap tightening. The claim set further covers method variants using subcutaneous tunneling and strap capture, and provides additional structural and device claims for strap locking/tensioning and strap geometry, along with cutter structures and guided strap retrieval.
Stated Advantages
Fewer steps and smaller incisions.
Reduced tissue pressure/tension.
Fewer knots/clamps.
Reduced complications vs mesh tacking.
Documented Applications
Ventral/abdominal wall hernia repair using a minimally invasive tissue defect closure with a self-locking strap and subcutaneous guide delivery.
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