Surgery Devices

Abstract

To provide a device and a method for removing an affected part of the colon and / or intestinum rectum and extracting the affected area via the colon.SOLUTION: A surgical device (102) includes a suture mechanism, the suture mechanism provided with a suture staple in a first row arranged along length in a longitudinal direction in a first arm (104) and a suture staple in a second row arranged along length in the longitudinal direction in a second arm (106), and a fixed length of suture thread including a first end region (130) and a second end region (132) connected to each other with an adjustable fastening part (122) that is formed in advance. A first threading region (134) of the suture thread extends through the suture staple in the first row; and a second threading area (136) of the suture thread extends through a suture staple in the second row.SELECTED DRAWING: Figure 14A

Description

Detailed Description

[0001]

[0001] DEVICES AND METHODS FOR MINIMALLY INVASIVE SURGICAL PROCEDURES CROSS-REFERENCE TO RELATED APPLICATIONS

[0002]

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 747,809, entitled "Devices and Methods for Minimally Invasive Surgical Procedures," filed October 19, 2018, which is incorporated by reference in its entirety. [Technical field]

[0003]

[0003] This application relates to minimally invasive surgical methods and devices for performing those methods. In particular, embodiments of the present invention relate to devices and methods for performing resection of diseased portions of the colon and / or rectum, and removal of diseased portions through the rectum. [Background technology]

[0004]

[0004] Surgery requiring removal of diseased portions of the intestine is common and is performed for a number of diseases including colorectal cancer, polyps, diverticulitis, Crohn's disease, ulcerative colitis, rectal prolapse, endometriosis, etc. The goal of such procedures is to preserve normal portions of the intestine while removing diseased portions of the intestine and perform an initial anastomosis to restore intestinal continuity. Laparoscopic and robotic surgery, typically referred to as minimally invasive surgery (MIS), are techniques in which procedures are performed with cameras and instruments placed through small ports in the abdomen, ranging from about 5 mm to about 12 mm in diameter, allowing visualization, access and exposure within the body cavity, and surgical procedures without the creation of open or large incisions.

[0005]

[0005] MIS has many benefits over traditional open surgery, including reduced incision and abdominal wall trauma, reduced postoperative pain, reduced opioid consumption, earlier return of bowel function, fewer complications, fewer hospital stays, and earlier return to activities of daily living. Currently, colorectal MIS typically requires the placement of four or five ports through the abdominal wall for minimally invasive instruments and cameras. For example, traditional laparoscopic procedures require ports with diameters of about 5 to about 12 mm, depending on the size of the camera and instruments. When diseased portions of the digestive tract need to be removed, one major drawback of current mainstream laparoscopic and robotic techniques is the use of an additional abdominal wall incision. This incision typically ranges from 5 to 8 cm in length, potentially doubling the cumulative incision size of the ports. The additional incision allows the surgeon to remove the diseased portions and perform all or some portions of the intestinal anastomosis directly through the incision.

[0006]

[0006] Currently, almost all laparoscopic and robotic procedures are performed using this additional incision. The vast majority of current practices do not use a natural orifice-assisted method to remove the specimen, nor do they attempt to overcome the difficult challenge of achieving a safe and successful intracorporeal anastomosis (ICA). Current methods utilize an abdominal wall incision to perform several surgical steps to prepare the intestine for anastomosis. To achieve these steps, the portion of the intestine designated for anastomosis is removed from the body through the abdominal wall incision, and the anvil of the circular stapler is placed and fixed. Thus, the laparoscopic or robotic portion of the procedure is interrupted to place an abdominal incision several centimeters long through which the specimen is exteriorized. After being exteriorized from the body cavity, the intestine is divided at the resection margins and the specimen is removed.

[0007]

[0007] Bringing a portion of the intestine outside the body cavity has many disadvantages, including the possibility of trauma or traction damage to the intestinal wall or associated blood vessels, the possibility that the end of the intestine may not be able to reach the abdominal wall in certain anatomical situations, and the possibility of contamination of the incision with intestinal contents, thereby increasing the risk of infection at the surgical site.

[0008]

[0008] Placing and utilizing additional transperitoneal incisions also has numerous drawbacks and significantly increases the invasiveness of the procedure. For example, such incisions can result in interruption of the flow of the procedure as the introduction of the incision results in loss of pneumoperitoneum and therefore suspending the minimally invasive platform. In laparoscopic surgery, the camera must be kept on standby and the instruments must be removed. In robotic surgery, one or more robotic arms must be completely detached from the patient to gain access and exposure. There is also the possibility of contamination of the abdominal wall incision, retraction injury of the bowel, incomplete resection of the specimen, additional procedure time, increased postoperative pain, increased need for opioid use, and increased morbidity.

[0009]

[0009] Therefore, there is a need to develop methods and devices that facilitate minimally invasive colorectal procedures that can perform resection, removal of disease, and creation of anastomoses without the need for incision of the abdominal wall or manipulation of the intestine outside the body cavity. Summary of the Invention

[0010]

[0010] Embodiments of the present invention provide a surgical device for use in surgery, such as natural orifice assisted surgery using laparoscopic or robotic systems.

[0011]

[0011] An embodiment of the present invention provides a suture clip applier for applying a suture around tubular tissue adjacent an open lumen, the suture clip applier comprising: an elongate body with a tissue fixation mechanism at one end, the tissue fixation mechanism comprising two arms movable between an open position and a fixed position; and a plurality of deformable suture clips mounted along a longitudinal length of the elongate body, each suture clip removably disposed within the two arms and configured to be deformed between the open position and the fixed position in response to the two arms being moved between the open position and the fixed position. A length of suture includes a preformed adjustable fastener and a loop extending from the preformed adjustable fastener, the loop configured to extend between the two arms of the suture clip applier.

[0012] According to certain embodiments, the suture clip applier includes a biasing element configured to longitudinally advance each deformable suture clip toward the tissue fixation feature. According to certain embodiments, the biasing element comprises one or more springs.

[0013] According to a particular embodiment, the two arms are hingedly attached to the elongated body of the clip applier.

[0014] According to certain embodiments, the suture clip applier includes between 4 and 20 deformable suture clips mounted along the longitudinal length of the elongate body.

[0015]

[0015] According to certain embodiments, the biasing element is configured to automatically advance each deformable suture clip toward the tissue fastening mechanism in response to the deformable suture clip being released from the fixing mechanism.

[0016]

[0016] According to certain embodiments, a method of applying sutures adjacent to an open lumen in tubular tissue using a suture clip applier includes sequentially attaching a series of deformable suture clips about the open lumen by actuating a tissue fixation mechanism to secure each deformable suture clip to the tubular tissue at a plurality of locations about the open lumen, with the suture extending through the deformable suture clips attached to the tubular tissue and forming a loop through the deformable suture clips.

[0017]

[0017] According to certain embodiments, the method includes a step of dividing the tubular tissue using a cutting element (e.g., scissors, a surgical stapler, etc.) to expose an open lumen prior to applying a series of deformable suture clips.

[0018]

[0018] According to certain embodiments, the method includes the step of tightening the suture around the open lumen.

[0019]

[0019] An embodiment of the present invention provides a surgical device for placing a suture around an intestine or other tubular tissue, the surgical device comprising a first arm and a second arm each having a longitudinal length with opposed proximal and distal ends, at least one of the first arm and the second arm being movable between an open position and a clamped position. The surgical device includes a suturing mechanism comprising a first row of suture staples disposed along a longitudinal length in the first arm and optionally a second row of suture staples disposed along a longitudinal length in the second arm, and a length of suture including first and second end regions joined together by a preformed adjustable fastener. A first threading region of the suture can extend through the suture staples of the first row and a second threading region of the suture can extend through the suture staples of the second row.

[0020]

[0020] According to certain embodiments, the length of suture includes a first non-threaded region extending along the longitudinal length of the first arm and a second non-threaded region extending along the longitudinal length of the second arm, and when the suture is removed from the surgical device, the suture is biased to straighten at the first and second bends, such that the suture forms a loop extending from the preformed adjustable fastener.

[0021]

[0021] According to certain embodiments, a first threaded region and a first non-threaded region of the suture are removably coupled to a first arm, a second threaded region and a second non-threaded region of the suture are removably coupled to a second arm, and first and second ends of the suture extend away from the first and second arms.

[0022]

[0022] According to certain embodiments, the surgical device includes a suturing mechanism having a pushing mechanism configured to expel suture staples from the interior portion when the suturing mechanism is actuated.

[0023]

[0023] According to certain embodiments, the surgical device includes a cutting mechanism having a groove extending along a longitudinal length of the first or second arm, and the cutting element includes a knife blade movably disposed in the groove, the knife blade configured to move along the longitudinal length.

[0024]

[0024] According to certain embodiments, the surgical device includes a stapling mechanism having a staple positioned along the longitudinal length of the first arm or the second arm and an anvil positioned along the longitudinal length of the other of the first arm or the second arm.

[0025] According to certain embodiments, the cutting mechanism is disposed along the longitudinal length between the suturing mechanism and the stapling mechanism.

[0026] According to certain embodiments, the stapling mechanism, the suturing mechanism, and the cutting mechanism are configured to be actuated simultaneously or substantially simultaneously.

[0027]

[0027] According to certain embodiments, a method of applying a suture around tubular tissue using a surgical system according to the above-described embodiments includes clamping the tubular tissue between a first arm and a second arm; activating the cutting mechanism to sever the tubular tissue thereby creating an open lumen; and activating the suturing mechanism to attach first and second rows of suture staples to the tubular tissue adjacent the open lumen, wherein the suture including a preformed adjustable fastener is removed from the surgical device and forms a loop around the tubular tissue with a portion of the suture extending through the suture staples.

[0028] According to certain embodiments, the method includes tightening the suture about the tubular tissue by pulling on one or more of the first and second ends of the suture.

[0029]

[0029] A method of intracorporeally resecting an intestinal specimen from a subject using a surgical system includes clamping first and second arms over a proximal resection margin between the specimen and a healthy intestinal portion; activating a cutting mechanism to divide the intestine at the proximal resection margin; activating a stapling mechanism to close the internal lumen of the specimen by applying staples to a proximal edge portion of the specimen; and activating a suturing mechanism to attach first and second rows of suture staples to the edge portion of the proximal intestinal portion, wherein a suture including a preformed adjustable fastener is removed from the surgical device and looped around the edge portion of the proximal intestinal portion with a portion of the suture extending through the suture staple.

[0030]

[0030] According to certain embodiments, the method includes the steps of clamping the first and second arms over the distal resection margin between the specimen and the healthy intestinal portion; actuating the cutting mechanism to divide the intestine at the distal resection margin; actuating the stapling mechanism to close the internal lumen of the specimen by applying staples to the distal edge portion of the specimen; and actuating the suturing mechanism to attach first and second rows of suture staples to the edge portion of the distal intestinal portion, wherein a suture including a preformed adjustable fastener is removed from the surgical device and looped around the edge portion of the distal intestinal portion, with a portion of the suture extending through the suture staples.

[0031]

[0031] According to certain embodiments, the steps of actuating the cutting mechanism, actuating the stapling mechanism, and actuating the suturing mechanism occur simultaneously or substantially simultaneously in response to a single actuation by the surgeon.

[0032]

[0032] According to certain embodiments, the method includes the step of removing the specimen through the rectum of the subject.

[0033]

[0033] According to certain embodiments, the step of extracting a specimen through the subject's rectum includes transanally inserting a grasping tool through the distal intestinal portion, grasping the specimen with the grasping tool, and extracting the specimen through the subject's rectum.

[0034]

[0034] According to certain embodiments, the method includes the step of forming an anastomosis in vivo, the step of forming an anastomosis in vivo includes inserting a circular stapler transanally and advancing the circular stapler through the distal intestinal portion, the circular stapler comprising a stapling cartridge and an anvil component removably coupled to the stapling cartridge.

[0035]

[0035] An embodiment of the present invention provides a transrectal extractor configured to expand the luminal circumference of the rectum, the transrectal extractor comprising a substantially cylindrical body including a deformable material extending along a longitudinal axis and having an exterior, an interior, and a top edge defining an opening to the interior, an optional drawstring extending through the interior and coupled to the top edge, and an optional outer sheath slidably coupled to and surrounding at least a portion of the exterior of the substantially cylindrical body. According to certain embodiments, the substantially cylindrical body is configured to be positioned within the rectal lumen (e.g., extending longitudinally from the opening in the lumen where the intestine is divided to or beyond the anal orifice) and expand outwardly, thereby increasing its circumference, to expand the luminal circumference of the rectum.

[0036]

[0036] According to certain embodiments, a method for intracorporeally removing a specimen from a subject using a transrectal extractor includes inserting the transrectal extractor transanally through a distal intestinal portion and expanding the top edge around an opening in the distal intestinal portion.

[0037]

[0037] According to a particular embodiment, the method includes the steps of inserting a grasping tool transanally through the transrectal retractor, grasping the specimen, and transanally extracting the specimen through the interior of the transrectal retractor.

[0038]

[0038] According to certain embodiments, the method includes removing the transrectal extractor by pulling the drawstring (eg, everting the top edge) to pull the substantially cylindrical body out of the rectum.

[0039]

[0039] An embodiment of the present invention provides a method for in vivo resection of a specimen from a subject, the method including the steps of: (1) separating the specimen from the intestinal wall by dividing the intestinal wall at a proximal resection margin, closing the proximal internal lumen of the specimen by applying staples to a proximal edge portion of the specimen, placing sutures around an edge portion of the proximal intestinal portion, dividing the intestinal wall at a distal resection margin, closing the distal internal lumen of the specimen by applying staples to a distal edge portion of the specimen, and placing sutures around an edge portion of the distal intestinal portion; (2) removing the specimen through the rectum of the subject; and (3) forming an anastomosis in vivo between the proximal and distal intestinal portions.

[0040]

[0040] According to certain embodiments, the method does not include making an abdominal wall incision, except for the port incision.

[0041] According to certain embodiments, the method includes isolating a specimen from an intestinal wall using a surgical device according to embodiments described herein, the surgical device including a first arm and a second arm each having a longitudinal length including opposed proximal and distal ends, at least one of the first arm and the second arm being movable between an open position and a clamped position, a cutting mechanism including a cutting element, and a first and second end region coupled to one another by a preformed adjustable fastener. the suturing mechanism comprising a length of suture, a first threading region of the suture extending through a first row of suture staples disposed along a longitudinal length in the first arm and a second threading region of the suture extending through a second row of suture staples disposed along a longitudinal length in the second arm, and optionally a stapling mechanism comprising staples disposed along the longitudinal length of the first arm or the second arm and an anvil disposed along the longitudinal length of the other of the first arm or the second arm.

[0042]

[0042] According to certain embodiments, the method includes the step of extracting the specimen using a transrectal extractor, the transrectal extractor including a deformable material extending along a longitudinal axis and having a substantially cylindrical body having an exterior, an interior, and a top edge defining an opening to the interior, an optional drawstring extending through the interior and coupled to the top edge, and an optional outer sheath slidably coupled to and surrounding at least a portion of the exterior of the substantially cylindrical body, the substantially cylindrical body configured to expand outwardly and increase the circumference of the opening, thereby expanding the luminal circumference of the rectum.

[0043]

[0043] The above summary, as well as the following detailed description, of embodiments of minimally invasive surgical methods and devices for performing those methods will be better understood when read in conjunction with the accompanying drawings of illustrative embodiments. It should be understood, however, that the invention is not limited to the precise arrangements and equipment shown. [Brief description of the drawings]

[0044] In the drawings:

[0045] [Figure 1] 1 is a diagram of the intestinal wall being divided at the proximal resection margin by a surgical device according to an exemplary embodiment of the present invention.

[0046] [Diagram 2] 1 is a diagram of an intestinal wall disrupted at a proximal resection margin in accordance with an exemplary embodiment of the present invention.

[0047] [Diagram 3] 1 is a diagram of an intestinal wall being divided at a distal resection margin by a surgical device according to an exemplary embodiment of the present invention.

[0048] [Figure 4] 1 is a diagram of an intestinal wall divided at proximal and distal resection margins according to an exemplary embodiment of the present invention.

[0049] [Diagram 5] FIG. 1 illustrates an exemplary rectal extractor attached to an exemplary circular stapler in accordance with an exemplary embodiment of the present invention.

[0050] [Figure 6] FIG. 1 illustrates an exemplary rectal extractor attached to an exemplary circular stapler in accordance with an exemplary embodiment of the present invention.

[0051] [Figure 7] 1A-1C are diagrams of an exemplary use of a rectal extractor and grasping tool in accordance with an exemplary embodiment of the present invention.

[0052] [Figure 8] FIG. 1 illustrates an exemplary use of transrectal extraction of a specimen in accordance with an exemplary embodiment of the present invention.

[0053] [Figure 9] 1A-1C are diagrams of an exemplary use of a rectal extractor in accordance with an exemplary embodiment of the present invention.

[0054] [Figure 10] 1 is a diagram of an exemplary circular stapler in accordance with an exemplary embodiment of the present invention;

[0055] [Figure 11] 1A-1C are diagrams of an exemplary use of an anvil and circular stapler in accordance with an exemplary embodiment of the present invention.

[0056] [Figure 12] 1A-1C are diagrams of an exemplary use of a trocar in a circular stapler in accordance with an exemplary embodiment of the present invention.

[0057] [Figure 13] 1A-1D are diagrams of an exemplary anastomosis in accordance with an exemplary embodiment of the present invention.

[0058] [Figure 14A] 1 is a diagram of one embodiment of an exemplary surgical device in accordance with an exemplary embodiment of the present invention. [Figure 14B] 1 is a diagram of one embodiment of an exemplary surgical device in accordance with an exemplary embodiment of the present invention. [Figure 14C] 1 is a diagram of one embodiment of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0059] [Figure 15A] 1 is a diagram of an exemplary surgical device in accordance with an exemplary embodiment of the present invention. [Figure 15B] 1 is a diagram of an exemplary surgical device in accordance with an exemplary embodiment of the present invention. [Figure 15C] 1 is a diagram of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0060] [Figure 16A] 1 is a diagram of a suture being applied around an intestinal wall by an exemplary surgical device in accordance with an exemplary embodiment of the present invention. [Figure 16B] 1 is a diagram of a suture being applied around an intestinal wall by an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0061] [Figure 17] 1 is a top view of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0062] [Figure 18] 1A-1C are diagrams of a first arm and a second arm of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0063] [Figure 19] FIG. 1 is a partial view of a surgical staple housed within an arm of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0064] [Figure 20] 1 is a perspective view of an arm of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0065] [Figure 21] 1 is a cross-sectional side view of an arm of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0066] [Figure 22] 1 is a partial view of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0067] [Diagram 23] 1 is a cross-sectional side view of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0068] [Figure 24] 1 is a diagram of an arm of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0069] [Diagram 25] 1 is a partial top view of an arm of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0070] [Figure 26] 1 is a partial view of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0071] [Figure 27] 1 is a top view of an arm of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0072] [Figure 28] FIG. 1 is a partial view of a suture staple housed within an arm of an exemplary surgical device in accordance with an exemplary embodiment of the present invention.

[0073] [Figure 29A] 1 is a perspective view of an exemplary surgical clip applier in accordance with an exemplary embodiment of the present invention; [Figure 29B] 1 is a perspective view of an exemplary surgical clip applier in accordance with an exemplary embodiment of the present invention;

[0074] [Figure 30A] 1 is a perspective view of an exemplary surgical clip applier and suture in accordance with an exemplary embodiment of the present invention; FIG. [Figure 30B] 1 is a perspective view of an exemplary surgical clip applier and suture in accordance with an exemplary embodiment of the present invention; FIG. [Figure 30C] 1 is a perspective view of an exemplary surgical clip applier and suture in accordance with an exemplary embodiment of the present invention; FIG.

[0075] [Figure 31A] 1A-1C are diagrams of an exemplary suture clip applier applying sutures and suture clips around an open lumen of an intestinal wall in accordance with an exemplary embodiment of the present invention. [Figure 31B] 1A-1C are diagrams of an exemplary suture clip applier applying sutures and suture clips around an open lumen of an intestinal wall in accordance with an exemplary embodiment of the present invention. [Figure 31C] 1A-1C are diagrams of an exemplary suture clip applier applying sutures and suture clips around an open lumen of an intestinal wall in accordance with an exemplary embodiment of the present invention. [Figure 31D] 1A-1C are diagrams of an exemplary suture clip applier applying sutures and suture clips around an open lumen of an intestinal wall in accordance with an exemplary embodiment of the present invention. [Figure 31E] 1A-1C are diagrams of an exemplary suture clip applier applying sutures and suture clips around an open lumen of an intestinal wall in accordance with an exemplary embodiment of the present invention. [Fig. 31F] 1A-1C are diagrams of an exemplary suture clip applier applying sutures and suture clips around an open lumen of an intestinal wall in accordance with an exemplary embodiment of the present invention. [Figure 31G] 1A-1C are diagrams of an exemplary suture clip applier applying sutures and suture clips around an open lumen of an intestinal wall in accordance with an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0076]

[0076] Embodiments of the present invention relate to minimally invasive methods for the endoscopic resection of a portion of a tubular tissue, and devices for performing those methods. In particular, embodiments of the present invention relate to minimally invasive methods for performing colorectal resections. For example, embodiments of the present invention relate to devices and methods for endoscopic resection of a portion of the colon and / or rectum, removal of the portion through the colon / rectum, and creation of an intracorporeal anastomosis (ICA) that does not require abdominal wall incisions, except for incisions required for a laparoscope or robotic port.

[0077]

[0077] An embodiment of the present invention facilitates ICA by using a device that applies a suture (e.g., a purse string suture, discussed below) having a preformed adjustable fastener (e.g., a preformed knot) to the intestinal wall, thereby allowing the suture to be tightened and closed without the need to apply the suture in a laparoscopic or robotic purse string style and tie a knot during surgery. An embodiment of the present invention also facilitates ICA by using a device that applies a purse string suture to one side of the divided intestinal wall and a closed staple line to the other side, optionally at the same time, e.g., simultaneously, in response to a single actuation by the surgeon. Conventional methods do not provide a viable method of placing a purse string suture in the intestine, except for laparoscopic or robotic intracorporeal suturing, which is a highly skilled and time-consuming procedure.

[0078] According to certain embodiments, transrectal specimen extraction from a natural orifice is facilitated by using a self-expanding rectal retractor designed for safe insertion and removal that limits damage to the rectal wall or dispersion of intestinal contents during the extraction process. Method embodiments disclosed herein also allow for intracorporeal placement of the anvil of a circular stapler by using the rectal lumen as a natural orifice. According to certain embodiments, the methods and devices disclosed herein result in resection, specimen extraction, and creation of an ICA without the need for any abdominal incision, except those required for laparoscopic or robotic ports, with all steps of resection and anastomosis being performed intracorporeally.

[0079]

[0079] As used herein, "resection" refers to the surgical removal or excision of a structure or part of a structure, such as a portion of a tubular tissue, e.g., a portion of the colon and / or rectum. For example, the methods described herein relate to the removal or excision of a diseased or defective portion of the intestine or bowel (e.g., a diseased or defective portion of the colon and / or rectum).

[0080]

[0080] As used herein, a "specimen" refers to a structure or a portion of a structure that has been surgically removed or is intended to be surgically removed. For example, the surgical methods described herein can include removal of a diseased or defective portion of the intestine or bowel (e.g., a diseased or defective portion of the colon and / or rectum), which is also referred to as a specimen. As used herein, intestine, bowel, colon, and rectum are non-limiting examples of "tubular tissues" having a lumen. In some cases, a specimen can be considered diseased and / or defective due to a disease or condition that affects the specimen, such as cancer, polyps, diverticulitis, Crohn's disease, ulcerative colitis, endometriosis, ischemic colitis, rectal prolapse, tumor, etc.

[0081]

[0081] As used herein, surgical steps performed "in vivo" refer to steps that take place within a body cavity, and surgical steps performed "extracorporeally" refer to steps that take place outside a body cavity.

[0082]

[0082] As used herein, "suture" refers to a length of flexible material (e.g., thread material), such as a flexible strand or thread of material suitable for use in surgical procedures. The suture may be a purse string suture that is placed around the edge of an open lumen in the intestinal wall and fastened to the intestine using multiple fasteners (e.g., suture staples or suture clips) such that when the suture is pulled tight, the intestinal opening closes. The suture material may be strong enough to hold tissue securely and flexible enough to tie a knot. Sutures may be made from a number of materials known in the art.

[0083]

[0083] As used herein, a preformed adjustable fastener refers to at least two regions of suture joined together by a fastening mechanism, with a loop of suture extending from the fastening mechanism (the loop configured to encircle a tubular tissue) that can be adjusted to tighten the suture loop around the tubular tissue by reducing the length or diameter of the loop (e.g., as shown in FIG. 12, tightening the loop around the intestine to close the intestinal lumen around a trocar or anvil shaft extending from the intestine when performing an anastomosis). In other words, the suture loop is tightened around the tubular tissue to draw the tissue edges together (e.g., a purse string suture). The terms "encircle" and "diameter" are used in reference to the loop formed by the suture, which is not necessarily circular but can be any shape (e.g., substantially circular, substantially oval, substantially teardrop shaped, etc.) that allows the loop to be placed around the tubular tissue. According to one embodiment (e.g., as shown in Figures 2-4), the preformed adjustable fastener can include a preformed adjustable knot that ties together two regions of suture and allows the surgeon to adjust the knot to tighten the loop of suture around the intestinal wall. Alternatively, it is contemplated that the preformed adjustable fastener can be knotless, and that the two regions of suture can be tied together by a connector, such as a ring or self-locking clip, that can be adjusted to tighten the loop of suture extending from the connector. The surgeon can tighten the suture loop around the tubular tissue by any suitable method (e.g., any suitable method known in the art for tightening a purse string suture).For example, a surgeon can pull on one or more ends of the suture extending from the pre-formed adjustable fastener, and / or pull or hold one or more ends tight while pushing the pre-formed adjustable fastener forward, and / or allow the pre-formed adjustable fastener to slide along the suture while holding one or more ends tight, thereby tightening the loop around the tubular tissue.

[0084]

[0084] As used herein, "port" is used interchangeably with "port incision" to refer to an incision configured for placement of laparoscopic and / or robotic instruments into a body cavity. A port incision does not include an incision through which a portion of the intestine (e.g., a portion of the colon and / or rectum) is exteriorized from a body cavity during surgery, and therefore does not include an incision through which a portion of the intestine (e.g., a resected portion of intestine) is removed from a subject's body.

[0085]

[0085] Laparoscopic and robotic surgery, typically referred to as minimally invasive surgery (MIS), is a technique in which procedures are performed with cameras and instruments placed through small port incisions, which can range from about 5 mm to about 12 mm, to facilitate visualization and surgical techniques within a body cavity (inside the body). Certain conventional types of laparoscopic and robotic surgery involving resection and anastomosis include both intracorporeal and extracorporeal steps, for example, the laparoscopic or robotic portion of the surgery is paused, thus allowing a portion of the intestine to be exteriorized from the body through an additional incision that is not a port incision (or an existing port incision may be extended to create a larger incision), and then those steps of the surgery (e.g., resection and / or anastomosis steps) are performed outside the body. According to certain embodiments of the present invention, all resection and anastomosis steps are performed inside the body, with no resection or anastomosis steps performed outside the body.

[0086] According to one embodiment, performing colorectal MIS involves placing a variable number of ports through the abdominal wall for minimally invasive instruments and cameras, but most commonly involves placing four or five ports. For example, laparoscopic surgery can include placing ports from about 5 to about 12 mm in diameter, depending on the size of the camera and instruments. According to one embodiment, the da Vinci Xi robotic platform utilizes three 8 mm diameter ports for the camera and robotic instruments, one 12 mm diameter port for a stapling device, and one 5 mm diameter accessory port for clinical support. The cumulative length / diameter of all port incisions, whether laparoscopic or robotic, can be about 40 mm. Due to their small size and minimal abdominal wall trauma, these ports alone result in minimal abdominal wall trauma, postoperative pain, and very low risk of port site hernia. As used herein, incision length, diameter, or size refers to the longest dimension (e.g., length or width) of the port, and the skin incision can be about 2 mm longer.

[0087] Each port incision can be about 15 mm or less in length, or about 12 mm or less, or about 10 mm or less. For example, one port incision can be about 5 mm in size, another about 12 mm in size to allow for placement of a robotic stapler, and three other ports about 8 mm in size. According to one embodiment, three to six port incisions are made, for example five port incisions. The total length of all port incisions can be about 45 mm or less, or about 40 mm or less, or about 35 mm or less.

[0088]

[0088] The present invention may provide a method of treating a disease or condition affecting the intestine of a subject, the method comprising using one or more of the embodiments of the surgical methods and / or devices described herein. For example, the surgical methods and devices of the present invention may be used to treat a benign condition. Alternatively, the surgical methods and devices of the present invention may be used to treat a malignant condition. Non-limiting examples of diseases or conditions that may be treated using the embodiments of the surgical methods and / or devices described herein include cancer (e.g., colorectal cancer, such as colon or rectal cancer), polyps, diverticulitis, Crohn's disease, ulcerative colitis, endometriosis, ischemic colitis, and rectal prolapse.

[0089] According to certain embodiments, the surgical method of the present invention is performed laparoscopically. According to additional embodiments, the surgical method of the present invention is performed robotically. As described herein, the steps of excising the specimen, removing the specimen via the rectum, and performing the anastomosis are performed intracorporeally, and no steps are performed extracorporeally, so this embodiment of the method does not include making any abdominal wall incisions, except for the port incisions.

[0090] 1-13, an embodiment of the method described herein includes removing a specimen 300 (e.g., a diseased or defective portion of the intestine, such as a diseased or defective portion of the colon and / or rectum) from an intestine or tubular tissue 107 having a central lumen 105, preserving the normal, unaffected, or "healthy" portion of the intestine that is not intended to be removed, and performing an anastomosis to restore intestinal continuity. The normal portions of the intestine or tubular tissue 107 that are not removed are referred to as the proximal intestinal portion 302 and the distal intestinal portion 304. After resection of the specimen 300, the proximal intestinal portion 302 and the distal intestinal portion 304 can be joined together to form an anastomosis 322, thus providing continuity between the proximal internal lumen 306 of the proximal intestinal portion 302 and the distal internal lumen 308 of the distal intestinal portion 304.

[0091] According to one embodiment, a method of in vivo resecting a specimen 300 (e.g., a diseased or defective portion of the intestine, such as a diseased or defective portion of the colon and / or rectum) from a subject includes in vivo resecting the specimen 300, removing the specimen 300 through the subject's rectum, and in vivo forming an anastomosis 322 between a proximal intestinal portion 302 and a distal intestinal portion 304. Resecting the specimen 300 can include separating the specimen 300 from the intestine by dividing the intestinal wall 212 at a proximal resection margin 312 (e.g., laterally across the lumen) to separate the specimen 300 from the proximal intestinal portion 302 and dividing the intestinal wall 212 at a distal resection margin 314 (e.g., laterally across the lumen) to separate the specimen 300 from the distal intestinal portion 304. Dividing the intestinal wall 212 at the proximal resection margin 312 and the distal resection margin 314 can be performed in any order, for example, the intestinal wall 212 can be divided at the proximal resection margin 312 and then at the distal resection margin 314, or the intestinal wall 212 can be divided at the distal resection margin 314 and then at the proximal resection margin 312.

[0092]

[0092] With reference to Figures 1 to 13, the method may include separating the specimen 300 from the proximal intestinal portion 302 by dividing the intestinal wall 212 at a proximal resection margin 312 (e.g., transversely across the lumen), thereby separating the specimen 300 from the proximal intestinal portion 302, optionally closing the proximal internal lumen 324 of the specimen 300 by applying staples 114 to a proximal edge portion 310 of the specimen 300, and placing sutures 118 around an edge portion 316 of the proximal intestinal portion 302 (the edge portion adjacent the open lumen). The steps of (1) dividing the intestinal wall 212 at the proximal resection margin 312, thereby separating the specimen 300 from the proximal intestinal portion 302, (2) closing the proximal internal lumen 324 of the specimen 300 by applying staples 114 to the proximal edge portion 310 of the specimen 300, and (3) placing sutures 118 around the edge portion 316 of the proximal intestinal portion 302 can be performed simultaneously or substantially simultaneously.

[0093]

[0093] For example, according to the embodiment shown in Figures 1-6, the method includes separating the specimen 300 from the distal intestinal portion 304 by dividing the intestinal wall 212 at the distal resection margin 314 (e.g., transversely across the lumen), thereby separating the specimen 300 from the distal intestinal portion 304, optionally closing the distal internal lumen 326 of the specimen 300 by applying staples 114 to the distal edge portion 318 of the specimen 300, and placing sutures 118 around the edge portion 320 of the distal intestinal portion 304 adjacent the distal internal lumen 308. The steps of (1) dividing the intestinal wall 212 at the distal resection margin 314, thereby separating the specimen 300 from the distal intestinal portion 304, (2) closing the distal internal lumen 308 of the specimen 300 by applying staples 114 to the distal edge portion 318 of the specimen, and (3) placing sutures 118 around the edge portion 320 of the distal intestinal portion 304 can be performed simultaneously or substantially simultaneously.

[0094] According to certain embodiments, the surgical instrument 102 is configured to apply the staples 114 and the sutures 118 simultaneously (e.g., in one motion) when actuated by the surgeon. The surgical instrument 102 may include a cutting mechanism 176, a stapling mechanism 174, and a suturing mechanism 172 that simultaneously or substantially simultaneously divide the intestinal wall at the distal resection margin 314, close the distal internal lumen 326 of the specimen 300 by applying the staples 114 to the distal edge portion 318 of the specimen 300, and place the sutures 118 around the edge portion 320 of the distal intestinal section 304, as disclosed in further detail below. According to certain embodiments, the suturing mechanism 172 of the surgical instrument 102 includes a suture having a preformed adjustable fastener (e.g., a preformed knot, such as a preformed slip knot).

[0095] 6-9, after isolating the specimen 300 from the normal or "healthy" intestine and optionally stapling its proximal and distal edge portions 310, 318 to close its proximal and distal inner lumens 324, 326, the method may further include extracting the specimen 300 through the subject's rectum. According to certain embodiments, extracting the specimen 300 through the subject's rectum includes transanally inserting a grasping tool 210 through the distal intestinal portion 304, grasping the specimen 300 with the grasping tool 210, and extracting the specimen 300 through the subject's rectum. According to one embodiment, the method includes transanally inserting a transrectal retractor 328 through the distal intestinal portion 304 and then inserting the grasping tool 210 through the transrectal retractor 328.

[0096] In one embodiment, a self-expanding transrectal retractor 328 is used to transrectally remove the specimen 300 (e.g., a portion of a resected intestine). The transrectal retractor 328 can be used with embodiments of the surgical methods described herein. The transrectal retractor 328 can be configured to be placed in the subject's rectum to substantially uniformly expand the intestinal wall (i.e., increase the circumference of the rectal lumen), prevent or reduce tearing or other trauma to the intestinal wall during insertion of the grasping device 210 through the rectum, and prevent or reduce contamination of the specimen 300 as it is removed through the rectum.

[0097] According to one embodiment, the transrectal retractor 328 comprises a substantially cylindrical body including a deformable material extending along a longitudinal axis. The substantially cylindrical body has an exterior, an interior passageway 202, and an apex edge 204 defining an opening to the interior passageway. The apex edge 204 is configured to expand around the opening into the intestinal lumen exposed by disrupting the intestinal wall, e.g., at the distal resection margin 314. According to one embodiment, a drawstring 206 extends through the interior passageway 202 and is coupled to the apex edge 204. When the transrectal retractor 328 is positioned in the intestinal lumen of the subject, the substantially cylindrical body extends longitudinally along a distance of the intestinal lumen, e.g., from the exposed opening of the intestinal lumen to or beyond the anal orifice, with the exterior of the substantially cylindrical body in contact with the inner wall of the intestine. By self-expanding, the transrectal retractor 328 expands and protects the intestinal lumen along its distance so that the grasping instrument 210 can be safely inserted transanally through the internal passageway 202 to grasp the specimen 300, which can be safely removed transanally without contacting the intestinal lumen. According to certain embodiments, the substantially cylindrical body includes a lower edge (not shown) at an end opposite the top edge, the lower edge also defining an opening to the internal passageway 202. The lower edge can be configured to remain outside the anal orifice.

[0098]

[0098] According to one embodiment, the transrectal retractor 328 is removably coupled to an insertion instrument insertable through the rectum, for example, the insertion instrument can be a conventional surgical instrument such as a circular stapler. The insertion instrument can be slidably removed from the transrectal retractor 328 after the transrectal retractor 328 is placed in the rectum. The method can further include inserting a grasping tool 210 and optionally an endoscope bag or an endocatch transanally through the transrectal retractor 328, grasping the specimen 300, optionally placing the specimen 300 through the transrectally inserted endbag, and transanally extracting the specimen 300 through the interior of the transrectal retractor 328. The method can further include removing the transrectal retractor 328 by pulling the drawstring 206, thereby pulling the substantially cylindrical body out of the rectum.

[0099]

[0099] According to one embodiment, the insertion instrument comprises an outer sheath 208 slidably coupled to and surrounding at least a portion of an exterior of a substantially cylindrical body. The material of the substantially cylindrical body is self-expanding (e.g., biased to expand outwardly when the outer sheath is removed). Thus, the substantially cylindrical body is configured to expand outwardly, increasing the circumference of its interior passageway, thereby expanding the luminal circumference of the rectum, for example, when the outer sheath 208 is slidably moved longitudinally away from the top edge 204.

[0100] According to one embodiment, the transrectal retractor 328 is removably coupled to a circular stapler 330 (e.g., FIG. 10), which comprises a stapling cartridge and an anvil component 336 removably coupled to the stapling cartridge. The top edge 204 can include a rim or expandable ring-like structure that includes a plurality of notches configured to removably secure the transrectal retractor 328 to the circular stapler.

[0101]

[0101] According to one embodiment, a method of intracorporeally resecting a specimen 300 from a subject using a transrectal retractor 328 includes inserting the transrectal retractor 328 transanally through the distal intestinal portion 304 (e.g., after dividing the intestine at the distal resection margin 314 to expose an opening to the lumen) and positioning the transrectal retractor 328 in the lumen of the intestine such that the apical edge 204 of the transrectal retractor 328 surrounds the opening to the lumen 308 in the distal intestinal portion 304.

[0102] 9-10, after the specimen 300 is removed from the subject, the method may further include forming an anastomosis 322 in vivo between the proximal intestinal portion 302 and the distal intestinal portion 304. Forming the anastomosis 322 in vivo may be performed by using a circular stapler 330. A variety of circular staplers are known in the art and are suitable for use with the present invention. According to certain embodiments, the circular stapler 330 includes an elongated shaft having an operating and adjustment mechanism utilized by a surgeon, and a stapling mechanism 334 attached to the elongated shaft. The stapling mechanism 334 includes a stapling cartridge 338, also referred to as a head unit, which includes a plurality of staples that may be configured in a substantially concentric circular array. Within the cartridge, a substantially circular or oval shaped knife may be concentrically attached within the staples for axial advancement. A movable trocar shaft 332 extends axially from the center of the cartridge and is adapted to have an anvil component 336 removably coupled thereto. The anvil component 336 is configured to form the ends of the staples as they are driven into the anvil component 336. The distance between the distal face of the staple cartridge 338 and the anvil component 336 is typically controlled by an adjustment mechanism attached to the stapler shaft to control the axial movement of the trocar 332. When the actuation mechanism is activated by the surgeon, tissue clamped between the staple cartridge 338 and the anvil 336 is stapled and cut, thereby allowing the suture staples and the staples to be extracted and therefore removed from the subject.

[0103] 11-13, the method may further include removing the anvil component 336 from the stapling cartridge 338, closing the edge portion 316 of the proximal intestinal portion 302 about the anvil component 336, and closing the edge portion 320 of the distal intestinal portion 304 about the stapling cartridge 330. Closing the edge portion 316 of the proximal intestinal portion 302 about the anvil component 336 may include tightening a suture 340 about a shaft 342 extending axially from the anvil component 336, and closing the edge portion 320 of the distal intestinal portion 302 about the stapling cartridge 330 includes tightening a suture 344 about a shaft extending axially from the stapling cartridge 330. The anvil component 336 and stapling cartridge 330 are then coupled together and the circular stapler is actuated to form an anastomosis 322 between the proximal and distal intestinal sections 302, 304, thereby providing continuity between the proximal interior lumen 306 of the proximal intestinal section 302 and the distal interior lumen 308 of the distal intestinal section 304. When the surgeon actuates the stapler, the staple attaches the two intestinal ends together and a knife (e.g., a substantially circular knife) within the stapler that is concentrically mounted within the staple severs and extracts the tissue surrounding the suture staples and sutures, and the extracted tissue, including the suture staples and sutures, is disposed within the stapler chamber for removal by the surgeon.

[0104] According to one embodiment, a method of applying sutures 118 around tubular tissue using a surgical device 102 (e.g., laparoscopically or robotically) includes inserting the surgical device into a body cavity via a port incision, clamping the tubular tissue between a first arm 104 and a second arm 106, activating a cutting mechanism 176 to sever the tubular tissue thereby creating an open lumen, and activating a suturing mechanism 172 to attach first and second rows of suture staples 120 to the tubular tissue adjacent the open lumen, where the suture 118, including the preformed adjustable fasteners 122, is removed from the surgical device 102 and forms a loop around the tubular tissue, with a portion of the suture 118 extending through the suture staples 120. As described herein, the suture 118 forms a loop when removed from the surgical device 102 or after being removed from the surgical device 102. For example, after the suture staple 120 is attached to the tubular tissue, the suture 118 may automatically detach or "drop" from the surgical device 102 after the first and second arms 104, 106 are opened (e.g., when the surgeon pulls the device away from the intestinal wall). As described herein, the steps of actuating the cutting mechanism 176 and actuating the suturing mechanism 172 may occur simultaneously or substantially simultaneously, for example, in response to a single actuation by the surgeon. The method may further include tightening the suture 118 around the tubular tissue by pulling one or more of the first and second ends 130, 132 of the suture 118, thereby sliding the preformed adjustable fastener 122 to close the loop.

[0105]

[0105] According to one embodiment, a method of intracorporeally resecting an intestinal specimen from a subject using a surgical device 102 (e.g., laparoscopically or robotically) includes inserting the surgical device into a body cavity via a port incision, clamping first arm 104 and second arm 106 over a proximal resection margin between the specimen 300 and a healthy intestinal portion, actuating cutting mechanism 176 to sever the intestine at proximal resection margin 312, and cutting a proximal edge portion 312 of the specimen 300. 10, actuating the stapling mechanism 174 to close the internal lumen 324 of the specimen 300 by applying staples 114 to the proximal intestinal section 302; and actuating the suturing mechanism 172 to attach first and second rows of suture staples 120 to the edge portion 316 of the proximal intestinal section 302, whereby the suture 118 including the preformed adjustable fasteners 120 is removed from the surgical device 120 and looped around the edge portion 316 of the proximal intestinal section 302; Activating the suturing mechanism 172, in which a portion of the suture 118 extends through the suture staple 120, clamping the first arm 104 and the second arm 106 over the distal resection margin 314 between the specimen 300 and the healthy intestinal portion, activating the cutting mechanism 176 to divide the intestine at the distal resection margin 314, and applying the staples 114 to the distal edge portion of the specimen 300 to close the internal lumen 324 of the specimen 300. and actuating the suturing mechanism 172 to attach first and second rows of suture staples 120 to an edge portion 320 of the distal intestinal section 304, where a suture 118 including a preformed adjustable fastener 122 is detached from the surgical device 102 and loops around the edge portion 320 of the distal intestinal section 304, with a portion of the suture 118 extending through the suture staples 120. As described herein, actuating the cutting mechanism 176, actuating the stapling mechanism 174, and actuating the suturing mechanism 172 occur simultaneously or substantially simultaneously in response to a single actuation by the surgeon.

[0106] 1 and 14-26, the surgical device 102 can be configured to apply the staples 114 and the sutures 118 simultaneously (e.g., in one motion) when actuated by a surgeon. The surgical instrument 102 can include a cutting mechanism 176, a stapling mechanism 174, and a suturing mechanism 172 that simultaneously or substantially simultaneously divide the intestinal wall 212 at the proximal resection margin 312, close the proximal internal lumen 324 of the specimen 300 by applying the staples 114 to the proximal edge portion 310 of the specimen, and place the sutures 118 around the edge portion 316 of the proximal intestinal section 302. According to certain embodiments, the suturing mechanism 172 of the surgical instrument 102 includes a suture having a preformed adjustable fastener 122 (e.g., a preformed knot such as a preformed slip knot).

[0107]

[0107] The surgical device 102 may include a suturing mechanism 172 that places a suture around a tubular tissue (e.g., an intestine such as the colon or rectum). According to certain embodiments, a length of suture including a preformed adjustable fastener (e.g., a preformed knot such as a preformed slip knot) is removably coupled to the surgical device. According to one embodiment, the suture is a purse string suture. By including a preformed adjustable fastener as part of the suture, the surgeon does not need to tie a knot on the suture after it is placed around the tubular tissue (e.g., around the intestinal wall). According to certain embodiments, the length of suture including a preformed adjustable fastener is held in the instrument in a "folded" or "bent" position, and upon removal from the instrument, the suture "unfolds" into a loop (the loop extending from the preformed adjustable fastener) that encircles the intestine or other tubular tissue. Thus, after the suture is placed around the tubular tissue, the surgeon can tighten the suture, for example, by pulling on the ends of the suture that extend from a preformed adjustable fastener (e.g., a preformed knot). As described herein, the surgical device can include a cutting mechanism 176 and / or a stapling mechanism 174 in addition to the suturing mechanism 172.

[0108]

[0108] According to one embodiment of the present invention, the surgical device 102 is connected to an actuation mechanism (not shown) (e.g., mechanically and / or electrically and / or remotely via computer), meaning that the actuation mechanism is in communication with the surgical device 102 and can therefore actuate the surgical device 102, e.g., via mechanical and / or electrical and / or remote means. The surgical device 102 and the actuation mechanism can form part of a surgical system, such as a laparoscopic and / or robotic surgical system. The actuation mechanism is used by the surgeon to control and actuate the surgical device, e.g., the surgeon can actuate the surgical device 102 in one movement, e.g., by pressing a button or pulling a trigger. During a surgical procedure, the surgical device 102 can be placed in a body cavity of the subject (e.g., through a port incision or natural orifice), and the actuation mechanism remains outside the body cavity and is controllable by the surgeon (e.g., the actuation mechanism can be part of a control center in a robotic system that allows the surgeon to view the surgical field and control the movements of the endoscopic instruments). 1, the surgical device 102 can be coupled to an arm 148 that forms part of a laparoscopic or robotic surgical system, such as the da Vinci surgical system. The actuation mechanism can include a handle portion that is grasped by the surgeon.

[0109]

[0109] With reference to Figures 1 and 14-28, the surgical device 102 comprises a first arm 104 and a second arm 106 each having a longitudinal length including opposed proximal ends 154, 156 and distal ends 155, 157. The first arm 104 and the second arm 106 are movable between an open position (e.g., Figure 14A) and a clamping position (e.g., Figure 15A). At least one of the first arm 104 and the second arm 106 is movable between the open position and the clamping position. In the clamping position, the first arm 104 and the second arm 106 can be closed onto a tubular tissue 107, for example onto an intestine. According to certain embodiments, the first arm 104 and the second arm 106 have a hinge mechanism 152 hingedly attaching the first arm 104 and the second arm 106 to each other at the proximal ends 154, 156. The first arm 104 and the second arm 106 can be formed as a single integral unit that is coupled together at the proximal ends 154, 156, or the first arm 104 and the second arm 106 can be formed as separate units that are then coupled together. When the first arm 104 and the second arm 106 are in the clamped position, the surgical device 102 can have a size small enough to fit through a port incision for placement within a body cavity. The overall height of the first arm 104 and the second arm 106 clamped together can be less than about 12 mm, between about 12 mm and about 15 mm, or greater than about 15 mm.

[0110] 14-24, the surgical device 102 can include a suturing mechanism 172 comprising a length of suture 118 (e.g., a purse string suture) extending through suture staples 120. According to one embodiment, a first row of suture staples 120 is disposed along a longitudinal length in the first arm 104 and a second row of suture staples 120 is disposed along a longitudinal length in the second arm 104, as shown for example in FIG. 17. The length of suture 118 includes a first end region 130 and a second end region 132, which include opposed first and second ends, respectively. According to certain embodiments, the first end region 130 and the second end region 132 are coupled together by a preformed adjustable fastener 122 (e.g., a preformed knot such as a preformed slip knot) with a first threading region 134 of the suture extending through the first row of suture staples 120 in the first arm 104 and a second threading region 136 of the suture extending through the second row of suture staples 120 in the second arm 106. In one embodiment, the length of suture 118 further includes a first non-threading region 138 extending along the longitudinal length of the first arm 104 and a second non-threading region 140 extending along the longitudinal length of the second arm 106. According to one embodiment, a first threaded region 134 and a first non-threaded region 138 of the suture are removably coupled to the first arm 104, a second threaded region 136 and a second non-threaded region 140 of the suture are removably coupled to the second arm 106, and first and second ends 130 and 132 of the suture, which are connected to each other by a knot, extend away from the first and second arms 104 and 106.

[0111] According to certain embodiments, the length of suture 118 is formed into a first bend 142 between the first non-threading region 138 and the first threading region 134, and a second bend 144 between the second threading region 136 and the second non-threading region 140. According to one embodiment, each of the first bend 142 and the second bend 144 is approximately 180 degrees such that, within the first arm 104, the first non-threading region 138 of the suture 118 is substantially parallel to the first threading region 134 of the suture 118, and within the second arm 106, the second non-threading region 140 of the suture 118 is substantially parallel to the second threading region 136 of the suture 118.

[0112]

[0112] The suture 118 is configured to be biased to straighten at the first bend 142 and the second bend 144 after removal from the surgical device 102, thus forming a loop (e.g., a substantially circular or oval loop) extending from the preformed adjustable fastener. For example, the suture 118 may be held in a "folded" position in the surgical device 102 (i.e., folded at the first bend 142 and the second bend 144) and when removed from the surgical device 102, the suture 118 "unfolds" or straightens into a loop 146 that extends from the preformed adjustable fastener 122 and surrounds or encircles the intestine or other tubular tissue 107. 16A and 16B, the suture end regions 130, 132 including the preformed adjustable fasteners 122 are moved to the opposite side of the intestinal wall (indicated by arrow "A" in FIG. 16A) after being detached from the first and second arms 104, 106. For example, after being detached from the first and second arms 104, 106, the suture 118 may automatically unfold to surround the intestine or other tubular tissue 107 (e.g., by going around the open lumen after being removed from the surgical device) or may be unfolded by the surgeon, for example, by utilizing a surgical tool to grasp the suture 118 and place it around an edge portion of the tubular tissue 107 adjacent the open lumen. According to one embodiment, the central bend 139 and threading regions 134, 136 of the suture 118 remain in a substantially fixed position in the intestinal wall after the suture staple 120 is applied to the intestinal wall, but the non-threaded regions, including the ends 130, 132 and the preformed adjustable fastener 122, are moved around the open lumen such that when the suture loop encircles the intestinal wall, the preformed adjustable fastener (e.g., knot) 122 is on the opposite side of the tubular tissue 107 from the central bend 139 located between the threading regions 134, 136.

[0113]

[0113] With reference to Figures 16A-18, a length of suture 118 can include opposed first and second ends 131, 133, a first end region 130, and a second end region 132. The first end region 130 of the suture 118 can extend from the first end 131 to the preformed adjustable fastener 122 and then to the proximal end 154 of the first arm 104, then the first non-threaded region 138 of the suture 118 extends from the proximal end 154 of the first arm 104 toward the distal end 155 of the first arm 104, then the suture 118 forms a first bend 142 adjacent the distal end 155 of the first arm 104, then the first threaded region 134 of the suture 118 extends through the first row of suture staples 120 toward the proximal end 154 of the first arm 104, then the suture 118 is threaded ... 8 forms a central bend 139 extending between the proximal ends 154, 156 of the first arm 104 and the second arm 106, then the second threaded region 136 of the suture 118 extends through the second row of suture staples 120 toward the distal end 157 of the second arm 106, then the suture 118 forms a second bend 144 adjacent the distal end 157 of the second arm 106, then the second non-threaded region 140 of the suture 118 extends toward the proximal end 156 of the second arm 106, and then the second end region 132 extends to the preformed adjustable fastener 122 and then to the second end 133.

[0114] 19-22, each suture staple 120 can include an aperture 127 through which the suture 118 extends. The suturing mechanism 172 of the surgical device 102 can include an interior portion 141 for receiving the suture staple 120 and one or more slots 143 for allowing the suture staple 120 to exit the interior portion 141. The surgical device 102 can also include a pushing mechanism 129 configured to push the suture staple out of the interior portion 141 when the suturing mechanism 172 is actuated, for example, the pushing mechanism 129 can include one or more protrusions disposed under each suture staple. Different embodiments of the pushing mechanism 129 are shown in FIGS. 21 and 22. According to certain embodiments, the suture staples 120 are configured to only partially penetrate the outer layer(s) of the tubular tissue, e.g., not all layers of the intestinal wall (unlike the surgical staples 114 described herein (e.g., FIGS. 22-24) that are configured to staple a specimen closed). In one embodiment, the suture staples 120 penetrate the tubular tissue to a sufficient depth that the sutures 118 extending through the suture staples 120 can be held in place around the tissue. According to certain embodiments, the suture staples 120 are housed within a suture staple cartridge, which can be disposable. For example, a disposable suture staple cartridge can be removably coupled to each arm 104, 106 of the surgical device 102 (e.g., by fitting the suture staple cartridge into the arm prior to use during surgery) and then detached from each arm after the suture staples 120 have been deployed following surgery. Alternatively, each arm 104, 106 can be disposable, with the arms 104, 106 being pre-loaded with suture staples 120 and discarded after surgery.

[0115] 19, each suture staple 118 has a staple body 161 with an elongated arm 125 including a loop 119 defining an opening 127 in the center of the arm. The loop 119 provides the opening 127 or eyelet for receiving a suture. The suture staple body 161 can have a pair of legs 121, 123 extending on either side of the arm 125. Alternative embodiments of the suture staple 120 are also contemplated, where the suture 118 is threaded through the suture staple 120 by other means.

[0116]

[0116] Referring to Fig. 24, the surgical device 102 of the present invention can include a suturing mechanism 172 and a cutting mechanism 176. The cutting mechanism 176 includes a cutting element 153 configured to transversely cut the tubular tissue (e.g., transversely cut the intestinal wall at a resection margin) to expose an open lumen. The cutting mechanism 176 can include, for example, a groove 155 extending along a longitudinal length of the first arm 104 and / or the second arm 106, and the cutting element 153 includes a knife blade movably disposed in the groove 155, the knife blade configured to move along the longitudinal length. The surgical device 102 can be configured such that the suture staple 120 is driven into the tubular tissue at the same time, immediately before, or immediately after the cutting element 153 cuts the tubular tissue, such that the suturing mechanism 172 and the cutting mechanism 176 can be actuated simultaneously or substantially simultaneously with a single actuation or movement by the surgeon.

[0117] 22, each of the first arm 104 and the second arm 106 includes a sled or sliding element 151 disposed beneath the suture staple 120, e.g., beneath the pushing mechanism 129 configured to push the suture staple 120. An embodiment of the sled or sliding element 151 is shown in FIGS. 22 and 24. The sled 151 can include multiple protrusions (e.g., angled protrusions) configured to slide beneath each protrusion of the pushing mechanism 129. When actuated by the surgeon (e.g., in response to an electrical signal from the actuation mechanism), the sliding element 151 is configured to slide longitudinally across each arm 104, 106 and push the suture staple 120, e.g., beneath the pushing mechanism 129, into the tubular tissue. The sliding element 151 can be coupled to a cutting element 153 (e.g., a knife blade) within the first arm 104 and / or the second arm 106 such that as the sliding element 151 moves across the arm(s) 104, 106, the cutting element 153 slices the tissue.

[0118] According to certain embodiments, the surgical device 102 of the present invention includes a suturing mechanism 172, a cutting mechanism 176, and a stapling mechanism 174. For example, a surgical stapler including a cutting and stapling mechanism 174 may also include the suturing mechanism 172 of the present invention. According to one embodiment, the first arm 104 and the second arm 106 of the surgical device 102 extend along a longitudinal axis 108, and the suturing mechanism 172 and the stapling mechanism 174 are each disposed along opposite sides of the longitudinal axis 108 (e.g., may be referred to as the suturing side 112 and the stapling side 110 of the surgical device). In one embodiment, the cutting mechanism 176 is disposed along the longitudinal length between the suturing mechanism 172 and the stapling mechanism 174 (e.g., substantially along the longitudinal axis 108). As discussed herein, a single actuation or movement by the surgeon can be configured to actuate the stapling mechanism 174, the suturing mechanism 172, and the cutting mechanism 176 simultaneously or substantially simultaneously, such that the staples 114 (i.e., surgical staples configured to staple tissue closed) and the suture staples 120 are driven into the tubular tissue at the same time, immediately before, or immediately after the cutting elements cut the tubular tissue.

[0119] 22-28, the stapling mechanism 174 can include an interior portion 128 for receiving the staples 114 and a plurality of staple slots 135 for allowing the staples 114 to exit the interior portion 128. The stapling mechanism 174 can include a pushing mechanism 117 configured to push the staples 114 toward the anvil 116 when the stapling mechanism 174 is actuated, e.g., when the sliding element 151 slides under the pushing mechanism 117. For example, the pushing mechanism 117 can include one or more protrusions disposed under each staple 114. The staples 114 are configured to contact the anvil 116 when the first arm 104 and the second arm 106 are in the clamping position. According to certain embodiments, the staples 114 are configured to completely penetrate the tubular tissue, e.g., penetrate all layers of the intestinal wall, and contact the anvil 116. The staples 114 can be arranged in multiple rows (e.g., two rows, three rows, four rows, or five rows) that are substantially parallel to one another. For example, three rows of staples are shown in FIGS. 20, 25, and 27-28. According to certain embodiments, the staples 114 are housed in a staple cartridge, which can be disposable. For example, a disposable staple cartridge can be removably coupled to an arm of the surgical device 102 (e.g., by fitting the staple cartridge into the arm prior to use during surgery) and then removed from the arm after surgery, after the staples 114 have been deployed. Alternatively, each arm 104, 106 can be disposable, with one arm including an anvil 116 and one arm preloaded with staples 114, and the arms discarded after surgery.

[0120] According to one embodiment, one or more disposable cartridges contain the suture staples 118 and the surgical staples 114, and the disposable cartridge(s) are removably coupled to the arms 102, 104 prior to use (e.g., by fitting into the interior portions 128, 141 of the arms 102, 104). A sled or sliding element 151 may form part of the disposable cartridge(s) containing the suture staples and the surgical staples. A cutting element 153 may form part of the disposable cartridge or, alternatively, may form part of the arm 102 or 104 of the surgical device. For example, the disposable cartridge(s) may include one or more grooves configured to receive a knife blade when removably coupled to the arm 102, 104.

[0121]

[0121] With reference to Figures 29A-31G, a suture clip applier 400 can be used to apply a suture 418 (e.g., a purse string suture) around a tubular tissue 407 adjacent an open lumen 434. Prior to applying the suture 418, the tubular tissue is divided by any known method to expose an open lumen, such as by a surgical stapler, scissors, or the like. For example, the tubular tissue can be divided at the proximal and / or distal resection margins. The suture clip applier 400 can be used with the surgical methods described herein (e.g., laparoscopic or robotic methods). For example, after a conventional cutting mechanism (e.g., a surgical knife, surgical scissors, surgical stapler, or the like) is used to laterally divide the tissue to expose an open lumen, the suture clip applier 400 can be inserted into the body cavity through a port incision and the suture clip applier 400 can be used to apply a suture around the open lumen of the tubular tissue.

[0122] 29A-30C, a length of suture 418 (e.g., a purse string suture) with a preformed adjustable fastener 422 (e.g., a preformed knot such as a preformed slip knot) is removably coupled to the suture clip applier 400. This allows the suture 418 to be tightened closed without having to place the purse string suture or tie a knot during surgery. Both the suture clips and suture staples described herein are utilized as fasteners to hold the suture in place around the tubular tissue, for example, the suture can be threaded through the suture clip or suture staple. According to certain embodiments, the suture clip 406 can be configured to only partially penetrate the outer layer(s) of the tubular tissue or can be configured to penetrate all layers of the intestinal wall (similar to the surgical staples 114 described herein that are configured to staple the specimen closed). In one embodiment, the suture clip 406 penetrates the tubular tissue to a sufficient depth to be able to hold the suture 418 extending through the suture clip 406 in place around the tissue while closing the purse string suture and drawing the tubular tissue into a closed position.

[0123]

[0123] The suture clip applier 400 can include an elongated body 402 with a tissue fixation mechanism 404 at one end of the body 402 configured to deliver a suture clip 406 to tissue. The suture clip applier 400 can be inserted directly through a port incision and placed in a housing to be used as part of a laparoscopic instrument, or placed in a housing to be used as part of a robotic instrument, such as a da Vinci. The tissue fixation mechanism 404 can include two arms 452, 454 that are movable between an open position (e.g., shown in FIG. 29A) and a closed or fixed position (e.g., shown in FIG. 29B) as the arms 452, 454 extend and retract, respectively. For example, the two arms 452, 454 can be part of a single integral unit or can be separately formed arms hingedly connected to the elongated body. The suture clip applier 400 further comprises a plurality of deformable suture clips 406 mounted along the longitudinal length of the elongate body 402. According to one embodiment, the suture clip applier 400 is configured to be in a closed / locked position for insertion through a port or housing prior to deployment of the suture clips 406, and to expand to an open position in which the two arms 452, 454 extend across the open edge of the intestinal wall.

[0124] According to one embodiment, each deformable suture clip 406 has two legs 426, 428 configured to penetrate tubular tissue, for example, each suture clip 406 may be curved with two ends configured to penetrate tubular tissue. Each suture clip 406 may be removably disposed within 408 of two arms 452, 454 and configured to deform between an open position and a fixed position in response to the two arms 452, 454 being moved between the open position and the fixed position. Any number of deformable suture clips 406 suitable for placing a suture around an open lumen may be included along the elongate body 402. For example, between 4 and 20 suture clips 406, between 6 and 20 suture clips 406, between 8 and 20 suture clips 406, between 6 and 15 suture clips 406, between 8 and 15 suture clips 406, between 6 and 12 suture clips 406, between 8 and 12 suture clips 406, or between 6 and 10 suture clips 406 may be attached along the longitudinal length of the elongate body 402. The length of suture 418 includes a preformed adjustable fastener (e.g., a preformed knot such as a preformed slip knot) 422 and a loop 424 extending from the preformed adjustable fastener 422, with the interior of the loop extending between two arms 452, 454 of the fixation mechanism 404. When the deformable suture clip 406 is in an operable position (ie, disposed within the two arms 452 , 454 of the fixing mechanism 404 ), the interior of the loop extends between the two legs 426 , 428 of the suture clip 406 .

[0125] According to one embodiment, the suture clip applier 400 includes one or more biasing elements 430 configured to longitudinally advance each deformable suture clip 406 toward the tissue fixation mechanism 404. For example, the biasing element 430 may include one or more springs. The biasing element 430 may be configured to automatically advance each deformable suture clip 406 toward the tissue clamping mechanism 404 in response to the deformable suture clip 406 being released from the fixation mechanism 404. Other configurations for advancing the suture clips 406 may also be used, such as a spring system, a pulley system, and / or other mechanical systems.

[0126]

[0126] According to one embodiment, a suturing system including the suture clip applier 400 can be connected to an actuation mechanism (e.g., mechanically and / or electrically and / or remotely via a computer), meaning that the actuation mechanism is in communication with the suture clip applier 400 and can thus actuate the suture clip applier 400 to attach each suture clip 406 to tissue, e.g., via surgeon-controllable mechanical and / or electrical and / or remote means.

[0127]

[0127] One embodiment of a method of applying a suture adjacent to an open lumen in tubular tissue using a clip applier is shown in Figures 31A-31G. According to a particular embodiment, the method includes actuating a tissue fixation mechanism 404 to secure a first deformable suture clip 432 to the tubular tissue at a first position adjacent to the open lumen 434 (i.e., to insert the clip into the tissue around an edge of the open lumen), with a portion of the suture loop 418 extending through (between) the first deformable suture clip 432. The tissue fixation mechanism 404 is opened after the first suture clip 432 is applied to the tissue and moved to a second position. Each subsequent location (first, second, third, fourth, fifth, etc.) is sequentially positioned around the tubular tissue so that the first location is adjacent to the second location, which is adjacent to the third location, which is adjacent to the fourth location, etc. A first clip 432 is applied at the first location, a second clip 436 is applied at the second location, a third clip is applied at the third location, etc.

[0128] After the first suture clip 432 is attached to the tissue in the first position, the second suture clip 436 is advanced by the biasing element 430 to an operable position within the arms 452, 454 of the fixation mechanism 404. Advancement of the next suture clip can occur automatically or in response to actuation by the surgeon. The tissue fixation mechanism 404 is actuated to secure the second deformable suture clip 436 to the tubular tissue in the second position, with a portion of the suture loop 418 extending through the first suture clip 432 and the second suture clip 436 (between the tubular tissue and the suture clips). Continuing this process, a series of deformable suture clips 406 (e.g., 4-20 suture clips 406, 6-20 suture clips 406, 8-20 suture clips 406, 6-15 suture clips 406, 8-15 suture clips 406, 6-12 suture clips 406, 8-12 suture clips 406, 6-10 suture clips 406) are sequentially attached around the open lumen by actuating the tissue fixation mechanism 404 to secure each deformable suture clip 406 to the tubular tissue at multiple locations around the open lumen. After the suture clips 406 are applied to the tissue, the suture 418 forms a loop that extends from the preformed adjustable fastener 422 through the deformable suture clip 406 attached to the tubular tissue (between the tubular tissue and the suture clip 406). The suture 418 is removed from the suture clip applier 400, for example, automatically or in response to actuation by the surgeon. The suture 418 can then be tightened in accordance with embodiments described herein (e.g., by pulling on the ends of the suture, etc.) to draw the lumen closed.

[0129]

[0129] The following examples further illustrate embodiments of the methods disclosed herein. EXAMPLES

[0130]

[0130] The embodiments encompassed herein will now be described with reference to the following examples, which are provided for illustrative purposes only, and the disclosure encompassed herein should not be construed as being limited to the examples, but rather as encompassing any variations that become evident in light of the teachings provided herein.

[0131] Example 1: Intracellular anastomosis of a natural orifice with transrectal extraction.

[0132]

[0132] The following method of intestinal division and natural orifice intracorporeal anastomosis with transrectal excision is performed in a stepwise manner designed for a robotic platform and without the use of abdominal wall incisions (only port incisions are used). The following steps are performed after mobilizing the affected section of intestine and dividing the mesentery of this section.

[0133] Step 1: A surgical device 102 (having a suturing mechanism 172 (FIG. 22), a cutting mechanism 176 (FIGS. 22 and 26), and a stapling mechanism 174 (FIG. 26) as described herein) is positioned across the intestinal wall at the proposed proximal resection margin 312 (FIG. 1) to deploy a closed linear staple line across the specimen 300 side and attach a purse string suture with a slip knot 122 to the proximal intestinal portion 302 (FIG. 2). Alternatively, the intestine is divided by any known method and a suture clip applier 400 as described herein is used to apply a purse string suture to the open proximal intestinal portion 302.

[0134] Step 2: The surgical device 102 is positioned across the intestinal wall at the proposed distal resection margin 314 (FIG. 3) and deploys a closed linear staple line across the specimen 300 side and attaches a purse string suture with a slip knot 122 to the distal intestinal portion 304 (FIG. 4). Alternatively, the intestine is divided by any known method and a purse string suture is applied to the open distal intestinal side using a suture clip applier 400 described herein.

[0135]

[0135] Step 3: With the assistance of the circular stapler (Fig. 5), a self-expanding transrectal retractor 328 is then introduced and deployed (Fig. 6) through the natural orifice of the rectum. After full expansion, the transrectal retractor 328 serves to spread the rectal stump and protect the intestinal wall while the specimen 300 is extracted.

[0136]

[0136] Step 4: The grasping tool 210 or other grasping forceps or endobag is placed through the transrectal retractor 328 to grasp the specimen 300 (FIG. 7). The specimen 300 is extracted transrectally through the transrectal retractor 328 (FIG. 8). The transrectal retractor 328 is then removed with the assistance of a drawstring (FIG. 9).

[0137]

[0137] Step 5: With the anvil 336 connected to the head component, the circular anastomosis stapler 334 is inserted through the anus into the distal intestinal section 304. The anvil 336 is pushed forward through the inner lumen 308 of the distal intestinal section 304 and into the abdominal cavity (FIG. 10).

[0138]

[0138] Step 6: The anvil 336 is removed and inserted into the interior lumen 306 of the proximal intestinal section 302. The intestinal wall tissue 316 is drawn into the shaft of the anvil 336 by tightening and securing the purse string suture via a slip knot (FIG. 11).

[0139]

[0139] Step 7: The open end of the distal intestinal edge 320 is drawn into the head component around the central trocar shaft 332 by tightening and securing the purse string suture with the aid of a slip knot (FIG. 12).

[0140]

[0140] Step 8: The anastomosis 322 is formed. The anvil 336 is pulled towards the head component. The circular stapler 334 is then closed, coupling the anvil 336 to the head to the desired location. The stapled circular anastomosis 322 is then created by severing the ends of the proximal and distal intestinal sections 302, 304 that were drawn into the stapler device along with the purse string sutures (FIG. 13).

[0141]

[0141] It will be appreciated by those skilled in the art that changes may be made to the exemplary embodiments shown and described without departing from the broad concept of the present invention. It will be appreciated, therefore, that the present invention is not limited to the exemplary embodiments shown and described, but is intended to encompass modifications within the spirit and scope of the present invention as defined by the claims. For example, specific features of the exemplary embodiments may or may not be part of the claimed invention, and various features of the disclosed embodiments may be combined. Unless otherwise stated herein, the terms "a," "an," and "the" should be read to mean "at least one" rather than limited to one element.

[0142]

[0142] It should be understood that, for purposes of clarity, at least some of the figures and descriptions of the invention have been simplified to emphasize elements that are important to a clear understanding of the invention, while excluding other elements that will be understood by those skilled in the art to form a part of the invention. Because such other elements are well known in the art and do not necessarily facilitate a further understanding of the invention, descriptions of such elements are not provided herein.

[0143]

[0143] Furthermore, to the extent that the method of the present invention does not rely on a particular order of steps set forth herein, the particular order of steps should not be construed as limiting the scope of the claims. Those skilled in the art will readily appreciate that claims directed to the method of the present invention should not be limited to the performance of those steps in the order described, and that steps may be modified and remain within the spirit and scope of the present invention.

Claims

1. 1. A surgical device for placing a suture around an intestine or other tubular tissue, comprising: The surgical device includes a first arm and a second arm each having a longitudinal length including opposed proximal and distal ends, at least one of the first arm and the second arm being movable between an open position and a clamped position; The surgical device includes a suturing mechanism; The suturing mechanism comprises: a first row of suture staples disposed along said longitudinal length in said first arm and a second row of suture staples disposed along said longitudinal length in said second arm; a length of suture including a first end region and a second end region joined together by a preformed adjustable fastener; Equipped with a first threading region of the suture extends through the first row of suture staples; a second threading region of the suture extends through the second row of suture staples; The suture is a preformed adjustable fastener that is slidably formed along the suture prior to use of the surgical device by a surgeon, allowing the surgeon to adjust the length or diameter of the suture loop by sliding the fastener along the suture; a first non-threaded region extending along a longitudinal length of the first arm; a second non-threaded region extending along a longitudinal length of the second arm; 23. A surgical device comprising:

2. the length of suture is formed into a first bend between the first non-threaded area and the first threaded area and a second bend between the second threaded area and the second non-threaded area; 10. The surgical device of claim 1, wherein when the suture is removed from the surgical device, the suture is biased to straighten at the first bend and the second bend such that the suture forms a loop extending from the preformed adjustable fastener.

3. 3. The surgical device of claim 2, wherein the first threaded region and the first non-threaded region of the suture are releasably coupled to the first arm, the second threaded region and the second non-threaded region of the suture are releasably coupled to the second arm, and first and second ends of the suture extend away from the first and second arms.

4. Further comprising a suturing mechanism having a pushing mechanism, The surgical device of claim 1 , wherein the pushing mechanism is configured to expel the suture staples from the interior portion when the suturing mechanism is actuated.

5. a cutting mechanism having a groove extending along a longitudinal length of the first arm or the second arm; The surgical device of claim 1 , wherein the cutting mechanism comprises a knife blade movably disposed in the groove, the knife blade configured to move along the longitudinal length.

6. 6. The surgical device of claim 5, further comprising a stapling mechanism having a staple disposed along the longitudinal length of the first arm or the second arm and an ambi disposed along the longitudinal length of the other of the first arm or the second arm.

7. The surgical device of claim 6 , wherein the cutting mechanism is disposed along the longitudinal length between the suturing mechanism and the stapling mechanism.

8. The surgical device of claim 7 , wherein the stapling mechanism, the suturing mechanism, and the cutting mechanism are configured to be actuated simultaneously.

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