FIELD OF THE INVENTION

The present invention relates to system, methods, and apparatus for enhancing the advancement and retention of suture through tissue.

BACKGROUND OF THE INVENTION

Suturing apparatuses in the past have had an elongate shaft and a low profile distal clamping mechanism to facilitate their use through cannulas in less invasive surgery. These devices have typically included opposing jaws which clamp onto the tissue to be sutured. The end segment of the suture is pre-positioned and secured at the distal end of one jaw member. Beyond the clamping motion, the mechanism for passing a suture between the jaws and through the tissue incorporates a bendable flat needle. The bendable needle advances distally within the jaw member, bringing it in contact with a segment of the suture. The needle has a notch which engages and secures the suture to carry it forward.

This distal advancement of the bendable needle also results in the leading end of the needle to approach and engage a ramp in the jaw member, deflecting the bendable needle in a direction toward the opposing jaw. The bending of the needle requires a high force and results in excess strain on the notched needle component. Fracture and failure of the bendable needle is a concern.

Additionally, capturing suture reliably after being passed through the tissue is also a feature not currently offered by the existing technologies. The ability to throw a horizontal mattress stitch with the desired stitch width without having to remove and reload the instrument is currently an unmet need. Another area of improvement is the need to clamp onto thick tissue and reliably pass suture.

Further, extension of the needle beyond the opposing jaw member and potentially puncturing tissue or bone is also a safety concern with existing technologies. This limits the versatility of existing technologies to create desired stitch patterns, such as the modified Mason-Allen stitch.

It is thus desirable to provide improved systems and methods for passing suture through biological tissue that substantially reduces or eliminates the disadvantages and drawbacks associated with conventional, known systems and methods for the advancement and retention of suture through tissue.

It is therefore an object of the present invention to provide systems and methods for passing suture through biological tissue that shields local biological tissue and bone from damage.

It is another object of the invention provide systems and methods for passing suture through biological tissue that allows a needle and/or suture to be driven into and through body tissue in an antegrade and retrograde direction during endoscopic procedures.

SUMMARY OF THE INVENTION

The present invention is directed to systems and methods for passing suture through biological tissue using a cannula, introducer or other minimally invasive means, to approximate, ligate, fixate and/or close biological tissue.

In a preferred embodiment, the suture passing device comprises a hand grip in operative communication with an elongated tubular member comprising an internal lumen and a jaw mechanism disposed on the elongated tubular member distal end.

In a preferred embodiment, the jaw mechanism comprises top and bottom members that are movable with respect to each other.

In some embodiments, the jaw mechanism bottom member comprises a first guide channel and the jaw mechanism top member comprises a second guide channel.

In some embodiments, the jaw mechanism top member comprises a pawl that is configured to provide a closure force that enables the pawl to capture at least a portion of suture between the pawl distal tip and the luminal wall of the top member guide channel.

In a preferred embodiment, the elongated tubular member comprises an internal lumen having a flexible tubular needle housed therein that is configured to carry a suture.

In a preferred embodiment, the suture passing device comprises a needle assembly that is configured to position a suture into and, optionally, through a tissue section.

In some embodiments, the needle assembly comprises at least one tubular needle having a tissue piercing distal end and a curvilinear portion. In a preferred embodiment, the tubular needle curvilinear portion is elastically deformable when in a constrained state and, upon release to an unconstrained state, reassumes the previous curvilinear shape.

In some embodiments, the tubular needle distal tip is configured to pierce and engage at least a portion of suture.

In a preferred embodiment, the tubular needle comprises an internal lumen that is configured to receive and contain a cleat member. In some embodiments, the cleat member partially extends from the tubular needle internal lumen and is configured to pierce and engage at least a portion of suture to prevent the suture from sliding down the tubular needle.

In some embodiments, the tubular needle comprises a hollow and rigid needle. In some embodiments, the tubular needle comprises a geometry where the area moment of inertia about the neutral bending axis is in the range of 23.0×10−9−300.0×10−9inches to the 4thpower, more preferably, the tubular needle comprises a geometry where the area moment of inertia about the neutral bending axis in the range of 25.0×10−9−75.0×10−9inches to the 4thpower, which allows the tubular needle to be driven into biological tissue with minimal deflection or skiving.

In some embodiments, the tubular needle is adapted to deform into a constrained state when the curvilinear portion of the tubular needle is advanced through the elongated tubular member internal lumen and into through the first guide channel of the jaw mechanism bottom member.

In some embodiments, the curvilinear portion of the tubular needle is adapted to reassume a curvilinear shape upon further advancement out of the first guide channel and into and through the second guide channel of the jaw mechanism top member.

In some embodiments, the jaw mechanism top member comprises a suture retriever component (or needle shield) that is configured to receive the tubular needle distal end without damaging the tubular needle distal end.

In a preferred embodiment, the needle shield comprises a deflecting trap-door mechanism that is configured to prevent the tubular needle distal end from proceeding beyond the top member and damaging extraneous biological tissue and bone.

In a preferred embodiment, the needle shield is configured to deflect and flex when the tubular needle distal end is slidably translated into the needle shield.

In some embodiments, the needle shield is configured to provide a closure force that enables the needle shield to capture at least a portion of suture.

In a preferred embodiment, the needle shield of the jaw mechanism top member enables antegrade and retrograde passing of suture during an endoscopic procedure, which allows an operator to generate a wide variety of stitch patterns including, without limitation, a modified Mason-Allen pattern.

