US-12622693-B2 - Flexible surgical stapler and staple insertion device

Abstract

The present invention relates to tissue approximation and fixation, and surgical staples and staple placement devices for surgery and the like. The present invention includes surgical staples having solid first and second legs for anchoring into respective tissue portions, and an elastically deformable bridge monolithically formed with the first leg and the second leg, the legs each forming respective angles greater than 90 degrees with respective portions of said elastically deformable bridge. The present invention also includes staple insertion device comprising a handle portion and substantially parallel insertion portions extending from the handle, the insertion portions each having an interior lateral channel, and each insertion portions having a terminal point.

Inventors

• Charles P. Chalekson
• David G. Matsuura
• Philip J. Simpson
• Nelson Siu

Assignees

• Tack Surgical, LLC

Dates

Publication Date

20260512

Application Date

20241015

Claims (4)

1. 1 . A staple insertion device comprising: a) a handle portion; and b) substantially parallel insertion portions extending from said handle, said insertion portions each having an interior lateral channel, and each insertion portions having a terminal sharp point adapted to pierce tissue; the insertion portions extending into said handle and adapted to slidingly engage a flexible staple and guide said flexible staple from a position within said handle to a position at the distal end of said parallel insertion portions, the insertion portions being configured to deform the flexible staple from a relatively expanded state to a relatively compressed state.
2. 2 . A staple insertion device according to claim 1 , additionally comprising a cartridge adapted to supply flexible staples in a series to said position within said handle.
3. 3 . A staple insertion device according to claim 2 wherein said substantially parallel insertion portions define a path along which a flexible staple may be urged such that, as said flexible staple is urged from a position within said handle toward a position at the distal end of said parallel insertion portions, said flexible staple is deformed from a relatively expanded state to a relatively compressed state.
4. 4 . A staple insertion device according to claim 2 , said cartridge containing a series of flexible staples, each said flexible staple comprising: a. a flexible staple bridge of a flexible resorbable suture material; and b. a pair of staple legs extending from said staple bridge, the staple legs adapted to be moved from a relatively compressed state wherein said staple legs are substantially parallel to a relatively expanded state, and wherein each of said staple legs additionally comprising interior lateral sides each comprising a lateral side barb directed at an angle to said lateral side, and exterior lateral sides each comprising an exterior lateral barb directed at an angle to said exterior lateral side, said lateral barbs shaped so as to resist the withdrawal from tissue once placed into tissue once the staple legs are inserted into tissue.

Description

RELATED APPLICATION DATA This application is a continuation of U.S. application Ser. No. 17/849,157, filed Jun. 24, 2022, now U.S. Pat. No. 12,114,855, which claims the priority benefit of U.S. Provisional Application Ser. No. 63/214,706, filed Jun. 24, 2021, all of which are hereby incorporated in their entirety herein by reference. FIELD OF THE INVENTION The present invention relates to tissue approximation and fixation, and surgical staples and staple placement devices for surgery and the like. BACKGROUND OF THE INVENTION In human and veterinary surgery, closure of the surgical site can be quite challenging and influential upon the overall outcome of the procedure. For example, many open and laparoscopic surgeries involve closure across multiple layers, or “levels” of tissue. The manner in which this closure is performed can be critical to a successful outcome and prevention of complications. The most effective approaches to multi-level closure involve carefully crafted approximations involving a variety of fixation techniques and devices. They are often not performed to the full extent possible due to their: (1) intensive time requirement; (2) difficulty of using traditional sutures in certain tissue layers; and (3) limited options in terms of device alternatives to sutures. Securing and closing multiple layers can easily occupy 50% of surgical times in specialties such as plastic surgery and other specialties. Even when they are performed, they are susceptible to significant failure, as they often involve somewhat precarious arrangements. For example, a continuous running suture might cause an entire tissue plane to lose securement suffer from even a single point along its course fails. Certain tissue planes do not accept traditional needle and suture material well, such as fat, loose areolar tissue planes and muscle. There is significant desire to close these planes and to remove dead space, but upon suturing, the material tears through resulting in very poor ability to atraumatically and successfully reinforce these sites which can result in significant scarring. Closure issues are also seen in intradermal closure, which affects all surgical specialties. Dermis is the one layer that all surgeons close. As mentioned above, running suture potentially compromises the entire incision. Other closure device options are bulky, have a tendency to extrude from the body prematurely, and are imprecise. In contrast, discontinuous securement in which sections of tissue are connected but individually locked in place allow for discrete and differential tensioning. This allows the surgeon to set more accurate, exacting, and reliable points of closure across multiple levels of tissue. Multiple layer closure further decreases tension on all other closure locations, resulting in less dehiscence, better soft tissue support [with maintenance of tissue positioning], and better scar outcomes. In addition, it can mitigate seroma and fluid accumulation, reducing or eliminating the need for surgical drains. Surgical procedures can result in creation of a void around tissues that normally have direct contact and adherence with other tissues. The primary medical concern with respect to this void, also referred to as “dead space” is that fluid, or sometimes gas, can collect within this space. A seroma is the collection of fluid within this potential space. Seromas most often occur at a surgical site where tissue has been intentionally elevated. Friction between these elevated layers, trauma to the tissue or an inflammatory response to foreign bodies [such as implants or mesh] may result in further production of this undesirable fluid. Seromas can cause discomfort, damage surrounding tissue, compromise normal healing, create a substrate for infection, and cause troublesome aesthetic issues. One option to decrease the risk is the placement of surgical drains, which may be left in place anywhere from a few days to multiple weeks. They require significant maintenance, are painful, and are mostly, but not completely effective at draining any fluid moving into the space. Drains do not prevent the production of fluid. One option to close and remove dead space is the placement of internal quilting sutures at the time of surgery. This entails the closure of elevated tissue planes with a large number of meticulously placed sutures to close and obliterate dead space, preventing friction and establishing contact to minimize fluid production. In this spirit, post-surgical compression garments applied to stabilize the tissue to limit edema and fluid production. In addition, the surgeon may frequently place one or more drainage tubes at the site. Nonetheless, swelling and fluid can collect either immediately or in delayed fashion, even many weeks after surgery. This can result in additional comorbidity, medical cost, and procedures for the patient, even jeopardizing the procedure success itself. Procedures prone to seromas and for which drains