US-12616461-B2 - Method of suturing a prosthetic to human tissue

US12616461B2US 12616461 B2US12616461 B2US 12616461B2US-12616461-B2

Abstract

A method of side-suturing a prosthetic to human tissue is disclosed. The method includes accessing a surgical site on a body portion of a patient; identifying the human tissue within the surgical site; endomechanically positioning the prosthetic adjacent the human tissue within the surgical site; aligning a surgical tool proximate the tissue with the prosthetic between the tool and the tissue, the surgical tool having an elongated member with distal and proximal ends; actuating the surgical tool in-situ to drive deployment members of the surgical tool outwardly away from the surgical tool, through the prosthetic and into the tissue; and retracting the deployment members back into the surgical tool, whereby the deployment members deploy a fastener to fixatedly suspend the prosthetic to the human tissue.

Inventors

Jafar HASAN
Michael J. Shoup
David Schaller
Jane KIERNAN
Karen NOBLETT
Daniel CAPUA
Adam Saban

Assignees

SURGIMATIX, INC.

Dates

Publication Date: 20260505
Application Date: 20230720

Claims (14)

1 . A method of securing a prosthetic to an organ, the method comprising of: accessing a surgical site on a body portion of a patient; identifying the organ within the surgical site; endomechanically positioning the prosthetic adjacent the organ within the surgical site; aligning a surgical tool proximate the organ with the prosthetic between the surgical tool and the organ, the surgical tool having an elongated member with distal and proximal ends; actuating the surgical tool in-situ, to drive deployment members of the surgical tool outwardly away from the surgical tool, through the prosthetic and into the organ; and retracting the deployment members back into the surgical tool, whereby the deployment members deploy a surgical fastener to fixatedly suspend the prosthetic to the organ.
2 . The method of claim 1 , wherein accessing the surgical site of the patient includes performing a laparoscopic procedure or an open abdominal procedure.
3 . The method of claim 1 , wherein the organ may be chosen from a group consisting of a prolapsed uterus, a prolapsed bladder, a prolapsed rectum, prolapsed vagina, a prolapsed bowel, a prolapsed urethra, prolapsed fallopian tubes, and prolapsed ovaries.
4 . The method of claim 1 , wherein the surgical site is a pelvic cavity.
5 . The method of claim 1 , wherein the surgical tool may be chosen from a group consisting of a suture passer, an endoscopic suturing device, a robotic suturing device.
6 . The method of claim 5 , wherein the surgical fastener is one of a plurality of surgical sutures, a plurality of surgical fasteners, and a plurality of surgical staples.
7 . The method of claim 1 , wherein the prosthetic is a mesh material made of a polymeric mesh material selected from a group consisting of a polypropylene, a polyethylene terephthalate (PET), a polyvinylidene fluoride (PVDF), a polyester, and a polyethylene.
8 . A method for performing sacrocolpopexy surgery for a prolapsed organ, the method steps comprising of: accessing a pelvic cavity of a patient; identifying the prolapsed organ within the pelvic cavity; inserting a mesh material into the pelvic cavity, extending from a first attachment site on the prolapsed organ to a second attachment site within the pelvic cavity; suturing, via a suturing device, the mesh material on the prolapsed organ, the suturing device drives deployment members in-situ and outwardly away from the surgical device, through the mesh material, into the first attachment site and back into the surgical device whereby the deployment members deploy a surgical fastener to fixatedly suspend the mesh material to the prolapsed organ; and suturing the mesh material to a human tissue at the second attachment site in the pelvic cavity to suspend the prolapsed organ within the pelvic cavity.
9 . The method of claim 8 , wherein accessing the pelvic cavity of the patient includes performing a laparoscopic procedure or an open abdominal procedure, and the method further includes: inserting the suturing device into the pelvic cavity when suturing the mesh material to the first attachment site and the second attachment site.
10 . The method of claim 8 , wherein suturing, via the suturing device, the mesh material to the first attachment site and second attachment sites includes using one of: a plurality of surgical sutures, a plurality of fasteners, a plurality of screws, and a plurality of staples.
11 . The method of claim 8 , wherein the second attachment site is located on a sacrum or a human tissue wall proximate to the sacrum.
12 . The method of claim 8 , wherein: the prolapsed organ may be chosen from a group consisting of a prolapsed uterus, a prolapsed bladder, a prolapsed rectum, a prolapsed vagina, a prolapsed bowel, a prolapsed urethra, prolapsed fallopian tubes, and prolapsed ovaries; and the mesh material comprises a polymeric mesh material selected from a group consisting of a polypropylene, a polyethylene terephthalate (PET), a polyvinylidene fluoride (PVDF), a polyester, and a polyethylene.
13 . The method of claim 8 , wherein the suturing device may be chosen from a group consisting of a suture passer, an endoscopic suturing device, a robotic suturing device, and wherein the suturing device is configured to include at least one of the following: an automated suture deployment feature, and an adjustable suture tension feature for accurate and consistent suturing.
14 . The method of claim 13 , wherein the first attachment site is on a side of the prolapsed organ.

Description

TECHNICAL FIELD The present disclosure relates to the field of surgical methods, and more particularly relates to surgical methods of suturing prosthetics to human tissue. BACKGROUND Pelvic organ prolapse is a prevalent condition affecting women, whereby organs such as the uterus, bladder, or rectum begin to descend or protrude in the pelvic cavity. Pelvic organ prolapse occurs when the muscles and human tissues that support the pelvic organs become weak or damaged. Healthy pelvic organs are supported by a pelvic floor and ligaments from the vagina to the backbone. Human tissue refers to living or non-living biological material derived from the human body, including cells, organs, or anatomical structures. Prosthetic, as described herein, refer to artificial devices or materials designed to be surgically secured by a suture, fastener, or staple within the body to replace, support, or enhance the function of a specific organ, tissue, or body part. A suture is a thread-like material used by surgeons to stitch or secure tissues together during a surgical procedure for the purpose of attaching prosthetics, wound closure, and/or tissue approximation. A fastener may be used by surgeons to secure tissues together during a surgical procedure for the purpose of wound closure or tissue approximation. Organs are distinct anatomical structures composed of specialized human tissues that perform specific functions within the body, such as the heart, lungs, liver, or kidneys. When the pelvic floor becomes stretched, weakened, damaged, or torn, it allows pelvic organs to slip out of their normal places or sag down as the ligaments will stretch over time causing pelvic organ prolapse. Different types of prolapse may occur, depending on the organ or organs involved. These may include uterine prolapse, vaginal prolapse, cystocele, rectocele, and enterocele. In uterine prolapse, the uterus and cervix drop down the vaginal canal potentially past the vaginal opening. Vaginal prolapse occurs when the top of the vagina drops down the vaginal canal, common with people who have had a hysterectomy (removal of their uterus). Cystocele occurs when the bladder bulges into the vagina. Rectocele occurs when the rectum bulges into the vagina. Enterocele occurs when the small intestine bulges against the vaginal wall. Sacrocolpopexy is a surgical procedure commonly used to address pelvic organ prolapse. It involves attaching a mesh material as a prosthetic between the sacrum and the vaginal wall to provide support to the prolapsed organs. The mesh material may initially be attached by passing a suture or needle separately through the mesh material and a human tissue (i.e. vaginal wall), or vice versa. The mesh material may also be subsequently secured using in-situ suturing techniques. In-situ suturing refers to the suturing of tissues while they remain in their natural anatomical position or location within the body. During the sacrocolpopexy surgery, a surgeon lifts the affected organs back into place and secures them with a surgical mesh material. Restoring pelvic organs to their normal position helps relieve side effects of prolapse like bulging, pelvic pressure, or urinary incontinence (leaking urine). Generally, surgeons perform sacrocolpopexy laparoscopically using small incisions and a camera. Some surgeons perform laparoscopic sacrocolpopexy with the aid of a robot. However, existing methods of surgery for suturing prolapsed organs present certain difficulties and limitations including a limited visibility of the surgical site, tissue handling, manual dexterity, and variabilities in anatomy of the patient. Hence, there exists a need for improving surgical attachment of prosthetics to human tissue that provides durable support to the prolapsed organs in a minimally invasive approach for improved patient outcomes. SUMMARY In accordance with one aspect of the disclosure, a method of suturing a prosthetic to human tissue is disclosed. The method comprises: accessing a surgical site on a body portion of a patient; identifying the human tissue within the surgical site; endomechanically positioning the prosthetic adjacent the human tissue within the surgical site; aligning a surgical tool proximate the human tissue with the prosthetic between the tool and the human tissue, the surgical tool having an elongated member with distal and proximal ends and a lateral side therebetween; actuating the surgical tool in-situ to drive deployment members of the surgical tool outwardly away from the lateral side, through the prosthetic and into the tissue; and retracting the deployment members back into the lateral side of the surgical tool leaving the prosthetic suspended from the tissue. In accordance with another aspect of the disclosure, a method of endomechanical suturing a prolapsed organ within a pelvic cavity of a patient is disclosed. The method steps comprises: accessing the pelvic cavity of the patient; identifying the prolapsed organ within