US-12616463-B2 - Multi-function systems, apparatus and methods for approximating, ligating and fixating soft tissue

US12616463B2US 12616463 B2US12616463 B2US 12616463B2US-12616463-B2

Abstract

A system for passing suture into and through soft tissue that includes a multi-function jaw mechanism, and a needle adapted to engage a suture and pierce into the soft tissue. The multi-function jaw mechanism adapted to capture the soft tissue, provide highly reliable suture loading and retrieval with minimal visual guidance, and measure stitch placement positions in the soft tissue in a confined surgical site for accurate and precise provision of complex stitch patterns. The system also includes system control means for synchronizing articulation of the jaw mechanism, articulation of the needle, and engagement of the suture by the needle and release of the suture therefrom.

Inventors

Scott Heneveld
John Valadez
Christopher Morris
Justin Anderson
Brad Topper
Jeffrey Sonntag

Assignees

PASSER STITCH, LLC

Dates

Publication Date: 20260505
Application Date: 20250916

Claims (16)

1 . A multi-function jaw apparatus, comprising: a jaw assembly comprising top and bottom jaw members, said top jaw member adapted to axially articulate with respect to said bottom jaw member, whereby said jaw assembly is adapted to transition from an open jaw configuration, wherein said top and bottom jaw members provide an open internal jaw region, to a closed jaw configuration, said open internal jaw region configured to receive a suture and soft tissue therein, said bottom jaw member comprising a bottom jaw member proximal end and a bottom jaw member distal end, said bottom jaw member further comprising a suture engagement region disposed on said bottom jaw member distal end, said suture engagement region comprising a raised proximal guide region, a raised distal guide region and a suture loading slot disposed between said raised proximal guide region and said raised distal guide region, said suture loading slot comprising a suture seat, said suture loading slot sized and configured to receive said suture therein and position said suture in said suture seat, said top jaw member and said bottom jaw member forming a suture containment region when said jaw assembly is in said closed jaw configuration, said top jaw member and said suture engagement region of said bottom jaw member forming a gap therebetween when said jaw assembly is in said closed jaw configuration, said gap sized to allow distal translation of said suture into said suture containment region when said jaw assembly is in said closed jaw configuration, said jaw assembly forming a suture backstop region in said suture containment region when said jaw assembly is in said closed jaw configuration, said suture backstop region configured to abate translation of said suture in a distal direction when said suture is disposed in said suture containment region.
2 . The apparatus of claim 1 , wherein said jaw assembly further comprises means for measuring a stitch placement location in said soft tissue when said soft tissue is positioned in said open internal jaw region of said jaw assembly.
3 . The apparatus of claim 2 , wherein said means for measuring a stitch placement location in said soft tissue comprises a first plurality of markers disposed on a first outer surface of said lower jaw mechanism, each of said first plurality of markers spaced a defined distance from said suture loading slot, whereby, when a border of said soft tissue is advanced into said open internal jaw region of said jaw assembly and aligned with a first marker of said first plurality of markers, a measurement of a first stitch placement location in said soft tissue is provided.
4 . The apparatus of claim 3 , wherein said means for measuring said stitch placement location in said soft tissue further comprises a second plurality of markers disposed on a second outer surface of said top jaw mechanism, said second plurality of markers positioned on said top jaw mechanism relative to said first plurality of markers, wherein said second plurality of markers and said first plurality of markers are aligned when said jaw assembly is in said closed jaw configuration.
5 . A system for approximating and fixating soft tissue, comprising: a needle comprising a tissue piercing distal end configured and adapted to releasably engage a suture and pierce into and through soft tissue with said suture said engaged thereto; a multi-function jaw mechanism adapted to receive and cooperate with said needle, wherein said needle is allowed to articulate with respect to said jaw mechanism, said multi-function jaw mechanism comprising top and bottom jaw members, said top jaw member adapted to axially articulate with respect to said bottom jaw member, whereby said multi-function jaw mechanism is adapted to transition from an open jaw configuration, wherein said top and bottom jaw members provide an open internal jaw region, to a closed jaw configuration, said open internal jaw region configured to receive said suture and said soft tissue therein, said bottom jaw member comprising a bottom jaw member proximal end and a bottom jaw member distal end, said bottom jaw member further comprising a suture engagement region disposed on said bottom jaw member distal end, said suture engagement region comprising a raised proximal guide region, a raised distal guide region and a suture loading slot disposed between said raised proximal guide region and said raised distal guide region, said suture slot comprising a suture seat, said suture loading slot sized and configured to receive said suture therein and position said suture in said suture seat for said engagement by said needle, said top jaw member and said bottom jaw member forming a suture containment region when said multi-function jaw mechanism is in said closed jaw configuration, said top jaw member and said raised proximal guide region of said suture engagement region of said bottom jaw member forming a gap therebetween when said multi-function jaw mechanism is in said closed jaw configuration, said gap sized to allow distal translation of said suture into said suture containment region when said multi-function jaw mechanism is in said closed jaw configuration, said multi-function jaw mechanism forming a suture backstop region in said suture containment region when said multi-function jaw mechanism is in said closed jaw configuration, said suture backstop region configured to abate translation of said suture in a distal direction when said suture is disposed in said suture containment region; and system control means for synchronizing said axial articulation of said top jaw member and said needle articulation.
6 . The system of claim 5 , wherein said multi-function jaw mechanism further comprises means for measuring a stitch placement location in said soft tissue when said soft tissue is positioned in said open internal jaw region of said multi-function jaw mechanism.
7 . The system of claim 6 , wherein said means for measuring a stitch placement location in said soft tissue comprises a plurality of markers disposed on an outer surface of said lower jaw mechanism, each of said first plurality of markers spaced a defined distance from said suture loading slot, whereby, when a border of said soft tissue is advanced into said open internal jaw region of said multi-function jaw mechanism and aligned with a first marker of said plurality of markers, a measurement of a first stitch placement location in said soft tissue is provided.
8 . The system of claim 5 , wherein said bottom jaw member further comprises a needle guide channel sized and configured to receive said needle therein and allow slidable translation of said needle therethrough and articulation of said needle therein.
9 . The system of claim 8 , wherein said multi-function jaw mechanism further comprises needle wear resistance means for increasing durability and longevity of said needle.
10 . The system of claim 9 , wherein said needle wear resistance means comprises first and second wear resistance members.
11 . The system of claim 10 , wherein said first wear resistance member is disposed in said lower jaw mechanism at a first abutment point of said needle when said needle is said received in said needle guide channel, and said second wear resistance member is disposed in said lower jaw mechanism at a second abutment point of said needle when said needle is said received in said needle guide channel and said translated therethrough.
12 . The system of claim 11 , wherein said first and second wear resistance members comprise a work-hardened stainless-steel alloy.
13 . The system of claim 12 , wherein said work-hardened stainless-steel alloy comprises Nitronic 60.
14 . The system of claim 11 , wherein said first and second wear resistance members comprise a work-hardened cobalt-chromium-nickel alloy.
15 . The system of claim 14 , wherein said work-hardened cobalt-chromium-nickel alloy comprises Elgaloy 60.
16 . The system of claim 5 , wherein said multi-function jaw mechanism further comprises a suture control system adapted to control release of said suture by said needle.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63/766,960, filed on Mar. 4, 2025, and is a continuation-in-part of U.S. application Ser. No. 19/271,062, filed on Jul. 16, 2025, which is a continuation of U.S. application Ser. No. 18/623,903, filed on Apr. 1, 2024, now U.S. Pat. No. 12,390,213, which claims the benefit of U.S. Provisional Application No. 63/456,513, filed on Apr. 2, 2023, and U.S. Provisional Application No. 63/602,605, filed on Nov. 26, 2023. FIELD OF THE INVENTION The present invention relates to multi-function systems, apparatus and associated methods for approximating, ligating and fixating soft tissue; particularly, soft tissue that is accessed via an endoscopic procedure. BACKGROUND OF THE INVENTION As is well established, approximating, ligating and fixating soft tissue, such as fascia, muscles, ligaments and tendons, is a fundamental aspect of many surgical procedures. The process of approximating, ligating and fixating soft tissue often involves passing suture through the soft tissue with a suture passing system or device. Various suture passing systems and devices have thus been developed and employed to pass suture through soft tissue, such as the device disclosed in U.S. Pat. No. 10,383,621 to Gregoire, et al. The Gregoire, et al. device, as well as most conventional suture passing devices, include an elongated shaft and a low-profile distal jaw mechanism that is adapted to be advanced into a surgical site via access cannula in minimally invasive surgical procedures. The jaw mechanism typically comprises top and bottom jaw members that are adapted to capture and position the soft tissue for passage of a suture therethrough. Conventional suture passing systems and devices also typically comprise means for positioning and capturing a portion of a suture and retracting the suture into the device after it is passed through soft tissue. Such means typically comprises a bendable needle having a suture capture end that is advanced into and through elongated shaft of the device and through a distal opening in the bottom jaw member. Several conventional suture passing systems also include suture retainment means that is adapted and configured to retain a portion of suture (usually in a top jaw member of a jaw mechanism) after the portion of suture has been drawn through soft tissue for manipulation by the system in a surgical site, e.g., forming a particular suture pattern. Although many conventional suture passing systems can effectively be employed to pass suture into and through soft tissue in a surgical site and retain a portion of the suture after passage through soft tissue, there are numerous drawbacks and disadvantages associated with the use of conventional suture passing systems and associated devices to approximate, ligate and fixate soft tissue. Major drawbacks and disadvantages associated with most conventional suture passing systems include difficultly manipulating soft tissue in a confined surgical site, cumbersome operation and, often complicated and sight dependent, suture loading procedures, and difficulty manipulating and retrieving suture in a confined surgical site. A further major drawback and disadvantage associated with conventional suture passing systems is that such systems are typically devoid of any means for effectively engaging and capturing soft tissue or a portion thereof (prior to or after passing suture therethrough) and surgical instruments in a surgical site during a surgical procedure. Yet another major drawback and disadvantage associated with conventional suture passing systems is that such systems are also devoid of any means for measuring stitch placement positions in soft tissue to accurately produce complex stitch patterns, such as modified Mason-Allen stitch patterns. The conventional systems solely rely on visual guidance by an operator to produce common and complex stitch patterns, which significantly limits a surgeon's ability to consistently provide precise stitch patterns. Difficulties with manipulation of soft tissue and the absence of any means for measuring stitch placement positions in soft tissue also limits the types of soft tissue that can be approximated and fixated by the conventional suture passing systems. A further drawback and disadvantage associated with conventional suture passing systems is that such systems are also typically devoid of any means for protecting the needles employed therewith from breakage in a surgical site during a surgical procedure, e.g., breakage resulting from contact with hard tissue, such as bone. A further drawback and disadvantage associated with conventional suture passing systems is that such systems typically have a limited life cycle due to needle wear and fatigue. There is thus a need for improved suture passing systems, apparatus and methods that substantially reduce or eliminate the disadvantages and drawbacks associated with c