Laparoscopic anastomosis device and method of use

Abstract

The device includes an elongate body and an end effector coupled to a distal end of the elongate body, the end effector including a first end effector element configured to hold a first coupler element, a second end effector element configured to hold a second coupler element, and first and second end effector elements coupling the first and second end effector elements to the elongate body, the end effector configured to move between a first configuration in which the first and second end effector elements are positioned at a first position where an axial end of the first tube is coupled to the first coupler element, a second position in which an axial end of the second tube is coupled to the second coupler element, and a third configuration in which the first and second end effectors close the coupler elements relative to the coupler to anastomose the first and second tubes.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS)

[0001] This application claims priority to and benefit of U.S. Provisional Application No. 63 / 409,115, entitled "Laparoscopic Anastomosis Devices and Methods of Use Thereof," filed September 22, 2022, the entire disclosure of which is incorporated herein by reference.

[0002] (Statement of Government Support)

[0002] This invention was made with government support under Contract No. 2026272 awarded by the National Science Foundation. The government has certain rights in this invention.

[0003] FIELD OF THE INVENTION

[0003] The embodiments described herein generally relate to devices for laparoscopically anastomosing two tubular structures. [Background technology]

[0004] An anastomosis is the connection of two luminal structures. Anastomotic connections are typically surgically performed on blood vessels (such as veins or arteries) or tubular gastrointestinal structures (such as the intestine). Conventional techniques allow an anastomosis to be completed end-to-end (called end-to-end anastomosis) or between the end of one structure and the side of another (called end-to-side anastomosis). Thousands of procedures requiring these anastomoses are performed daily around the world. Similarly, in multiple surgical specialties, the success of each patient's treatment depends on the reliable and non-occlusive performance of an anastomosis. Surgical reattachment of veins and arteries (sometimes referred to herein as anastomosis for brevity) helps restore blood circulation, resulting in improved delivery of oxygen and other nutrients to downstream tissues and improved recovery of deoxygenated blood from tissues back into the circulatory system. Therefore, minimally invasive procedures are desirable to perform various vascular anastomosis procedures reliably and with reduced complications. Summary of the Invention

[0005]

[0005] Embodiments described herein relate to microsurgical instruments, minimally invasive surgery, and laparoscopic surgical devices. More specifically, embodiments described herein relate to systems, methods, and devices for performing anastomosis of tubular structures via minimally invasive or laparoscopic surgical approaches. Embodiments described herein further relate to laparoscopic systems, methods, and devices intended for use with couplable rings or other anastomotic couplers used in microvascular anastomosis to facilitate end-to-end or end-to-side joining of vascular structures (such as arteries and / or veins).

[0006] In some embodiments, the device comprises an elongate body and an end effector coupled to a distal end of the elongate body, the end effector comprising a first end effector element defining a first receiving portion configured to hold a first coupler element of a coupler, a first articulated drive member coupling a proximal end of the first end effector element to the elongate body, a second end effector element defining a second receiving portion configured to hold a second coupler element of the coupler, and a second articulated drive member coupling a proximal end of the second end effector element to the elongate body, the end effector comprising: (i) the first and second articulated drive members coupled to a first tube; (ii) a second configuration different from the first configuration in which the first and second articulation drive members position the first and second end effector elements such that a first axial end of the second tube is received in the first coupler element; and (iii) a third configuration in which the first and second articulation drive members position at least a portion of the first end effector element adjacent to a corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element and connecting the first tube to the second tube.

[0007]

[0007] In some embodiments, the device comprises a first end effector element defining a first receiving portion configured to hold a first coupler element of the coupler, a first articulation drive member coupling a proximal end of the first end effector element to the elongate body, a second end effector element defining a second receiving portion configured to hold a second coupler element of the coupler, the distal end of the second end effector element being coupled to the distal end of the first end effector element such that the first and second effector elements are articulatable about their respective distal ends, and a second articulation drive member coupling a proximal end of the second end effector element to the elongate body; The end effector is configured to move between (i) a first configuration in which the first and second articulation drive members position the first and second end effector elements such that a first axial end of the first tube is received in the first coupler element; (ii) a second configuration different from the first configuration in which the first and second articulation drive members position the first and second end effector elements such that a second axial end of the second tube is received in the second coupler element; and (iii) a third configuration in which the first and second articulation drive members position at least a portion of the first end effector element adjacent to a corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element to couple the first tube to the second tube.

[0008] In some embodiments, a method for performing an anastomosis of a first tube and a second tube within a patient's body includes inserting a distal end of an elongate body of an apparatus into the patient's body, wherein an end effector is coupled to the distal end of the elongate body, the end effector comprising a first end effector element coupled to the elongate body via a first articulation drive member and a second end effector element coupled to the elongate body via a second articulation drive member. A second coupler element of the coupler is positioned in a second receiving portion of the second end effector element. The distal end of the elongate body is inserted into the patient's body. The end effector is moved to a first configuration in which at least a portion of the first end effector is generally perpendicular to an axis of the elongate body. An axial end of the first tube is inserted through the first coupler element. The end effector is moved to a second configuration in which at least a portion of the second end effector element is generally perpendicular to the axis of the elongate body. The axial end of the second tube is inserted through the second coupler element. The end effector is moved to a third configuration, moving at least a portion of the first end effector element adjacent to a corresponding portion of the second end effector element to couple the first coupler element to the second coupler element, thereby coupling the first tube to the second tube. The first coupler element is disengaged from the first end effector element, and the second coupler element is disengaged from the second end effector element.

[0009]

[0009] In some embodiments, a method for anastomosis includes, after an end effector of an anastomosis device is positioned within a patient's body, transitioning the end effector to a first configuration, and receiving an axial end of a first tube through a first coupler element mounted on a first portion of the end effector when the end effector is in the first configuration, transitioning the end effector to a second configuration different from the first configuration, and receiving an axial end of a second tube through a second coupler element mounted on a second portion of the end effector when the end effector is in the second configuration, transitioning the end effector to a third configuration that positions at least a first portion of the end effector adjacent to the second portion of the end effector, thereby coupling the first coupler element to the second coupler element, and thus coupling the first tube to the second tube, and releasing the first and second coupler elements from the end effector.

[0010]

[0010] All combinations of the above-described concepts and additional concepts discussed in more detail below (where such concepts are not mutually inconsistent) are considered to be part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter listed at the end of this disclosure are considered to be part of the inventive subject matter disclosed herein. [Brief explanation of the drawings]

[0011]

[0011] The above and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, which illustrate only some embodiments in accordance with the present disclosure and, therefore, are not intended to limit the scope of the present disclosure, and the present disclosure will be described with more specificity and detail using the accompanying drawings.

[0012] [Figure 1A] 1 is a schematic diagram of an apparatus for performing laparoscopic anastomosis of two vessels. [Figure 1B]

[0012] FIG. 1B is a schematic diagram of a distal portion of the device of FIG. 1A, showing how a first tube and a second tube are connected to each other via the device of FIG. 1A, according to one embodiment. [Figure 2]

[0013] 1 is a schematic diagram illustrating a laparoscopic device for connecting a first tube to a second tube using an anastomosis device relative to a patient's body, according to one embodiment. [Figures 3A-3H]

[0014] 1A-1C are schematic diagrams illustrating various steps of a method for connecting a first tube to a second tube using an anastomosis device, according to one embodiment. [Figures 4A-4F]

[0015] 1A-1C are various perspective views of an anastomosis device illustrating various steps for connecting a first tube to a second tube, according to one embodiment. [Figure 5A-5B]

[0016] 1 is a flowchart of a method for laparoscopically connecting a first tube to a second tube, according to one embodiment. [Figure 6]

[0017] FIG. 1 is a perspective view of a portion of an apparatus for performing a laparoscopic anastomosis of two vessels, according to one embodiment. [Figures 7A-7B]

[0018] 7A and 7B illustrate a first actuator for moving an end effector element of the device of FIG. 6 between a partially open position (FIG. 7A) and a fully open position (FIG. 7B), according to one embodiment. [Figure 8A]

[0019] 7 is a perspective view of a portion of the device of FIG. 6, showing a second actuator configured to move an end effector of the device between various angular orientations, according to one embodiment. [Figure 8B]

[0019] The end effector of Figure 6 is shown in a first angular orientation. [Figure 9A]

[0020] 9A is a side view of a portion of the device of FIG. 6 illustrating a third actuator configured to move an end effector of the device from an open configuration to a closed configuration, according to one embodiment. [Figure 9B-9D]

[0020] Figure 7 shows the end effector of the device of Figure 6 in a closed configuration facilitated by a third actuator. [Figures 10A-10C]

[0021] 10A, 10B, and 10C show side views of the end effector of the device of FIG. 6 in a first configuration (FIG. 10A), a second configuration (FIG. 10C), and an angular orientation between the first and second configurations (FIG. 10B). [Figure 11]

[0022] 7A-7C show the end effector of the device of FIG. 6 in various angular orientations facilitated by first, second, and third actuators. [Figures 12A-12C]

[0023] 1 illustrates a side view of an end effector with alignment features and alignment members according to one embodiment.

[0013]

[0024] Reference will be made throughout the following detailed description to the accompanying drawings, in which like numerals generally refer to like elements unless the context indicates otherwise. The illustrative embodiments set forth in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit and scope of the subject matter described herein. It will be understood that the aspects of the present disclosure, as generally described and illustrated herein, can be arranged, substituted, combined, and designed in a variety of different configurations, all of which are expressly made a part of this disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0014]

[0025] FIELD OF THE INVENTION

[0002] Embodiments described herein relate to microsurgical instruments, minimally invasive surgery, and laparoscopic surgical devices. More particularly, embodiments described herein relate to systems, methods, and devices for performing anastomoses of tubular structures via minimally invasive or laparoscopic surgical approaches. Embodiments described herein also relate to intraoperative laparoscopic systems, methods, and devices intended to facilitate end-to-end joining of vascular structures (e.g., arteries and / or veins) when used in conjunction with connectable rings or other anastomotic couplers used in microvascular anastomosis.

[0015]

[0026] An anastomosis is the connection of two luminal structures. Anastomotic connections are typically surgically performed on blood vessels (such as veins or arteries) or tubular gastrointestinal structures (such as the intestine). Conventional techniques allow an anastomosis to be completed end-to-end (called end-to-end anastomosis) or between the end of one structure and the side of another (called end-to-side anastomosis). Thousands of procedures requiring these anastomoses are performed daily worldwide. Similarly, in multiple surgical specialties, the success of each patient's treatment depends on the secure and non-occlusive performance of an anastomosis. Surgical reattachment of veins helps restore blood circulation, resulting in improved delivery of oxygen and other nutrients to downstream tissues and improved recovery of deoxygenated blood from the tissues back into the circulatory system. It is desirable to perform various vascular anastomosis procedures using minimally invasive procedures with reduced complexity.

[0016]

[0027] The first technique for performing anastomosis was devised by Alexis Carrel, who later received the Nobel Prize in 1912 for his pioneering work. Despite 110 years of surgical advances and innovations since the development of microanastomosis, the majority of vascular anastomoses to this day still employ suturing techniques similar to those originally described by Carrel in the early 1900s. In the 1970s, gastrointestinal stapling devices were introduced, rapidly replacing earlier suturing techniques for intestinal anastomoses. However, many surgeons still employ peripheral sutures in the serosal layer overlying the stapled anastomosis for added support. While generally successful, these techniques can be time-consuming, often require additional surgical expertise, and, if not performed correctly, can result in leakage (e.g., of blood, fecal contents, stomach contents, lymphatic fluid), contraction, stenosis, and / or obstruction at the anastomosis site. In the case of vascular anastomoses, stenosis and / or occlusion can lead to serious complications such as myocardial infarction, stroke, peripheral limb ischemia, amputation, death, reconstruction failure, and soft tissue loss.

[0017]

[0028] As the importance of reliable, open anastomoses is increasingly understood, microvascular anastomosis couplers can provide a superior alternative to sutures and staples. Microvascular anastomosis couplers can consist of two circular coupler rings, each with a tissue-engaging surface and multiple sharp spikes. A vessel is threaded through the center of each ring, and the vessel wall is everted, or flipped, over the tissue spikes for fixation. After this is completed at each vessel end, the two rings are brought together so that the spikes / pins are pressed into the opposing ring, joining the ends together.

[0018]

[0029] Microanastomotic coupling devices, such as the GEM™ FLOW COUPLER device, can be used to achieve microvascular anastomosis of blood vessels. However, current anastomotic couplers are not designed for, nor are they easily adapted for, minimally invasive procedures such as laparoscopic surgery or microsurgery due to poor visibility, limited working space, and the lack of a device for applying two anastomotic couplers together that can be introduced through the small diameter of a trocar port.

[0019]

[0030] Due to the lack of reliable devices or techniques for applying anastomotic couplers in laparoscopic surgery, manual suturing is primarily used for surgical joining of blood vessels in minimally invasive procedures. Manual suturing of blood vessels can be quite challenging, primarily due to the small size of the vessels and limited working space. Because most vessels are only 1–8 mm in diameter, the procedure typically involves the use of an operating microscope. Sutures are approximately 70 μm thick and can be difficult to handle. As a result, surgeons and surgical residents must undergo extensive additional training before performing surgery on patients requiring tissue transfer. Furthermore, surgeons attempt to limit recipient-site morbidity, resulting in smaller incisions and a smaller working area. For example, in microsurgery for breast reconstruction after mastectomy, surgeons typically work within a 2.5–3 cm surgical field. These size constraints make it difficult for surgeons to manipulate surgical instruments. Arterial anastomosis performed by hand suturing takes approximately 23.5 minutes in the operating room and is undesirable.

[0020]

[0031] Embodiments of the anastomosis device and methods of use described herein may provide one or more advantages, including, for example, the following: 1) enabling minimally invasive laparoscopic surgery for performing an anastomosis of two tubular tissues, e.g., tubes, nerves, etc., through small incisions less than about 25 mm in diameter; 2) enabling anastomosis by simple clamping of coupler elements through an end effector having a pair of end effector elements configured to separate or approximate the coupler elements and connect the elements, allowing two tubes to be anastomosed in about 5 minutes or less; 4) providing surgical flexibility by articulating the end effector about a longitudinal axis, allowing the end effector to access hard-to-reach areas; 5) providing an elongated body to which the end effector is coupled, the elongated body being greater than about 8 inches in length, allowing insertion through an incision in the abdominal wall or other portion of the user's body, while allowing for anastomosis of tubes in the patient's pelvic floor; 6) providing an anastomosis interface from an end effector having a pair of end effector elements configured to separate or approximate the coupler elements and connect the elements; 6) providing a multi-functional interface that allows for all anastomosis-related operations to be performed, thereby reducing the use of manual forceps; 7) providing a vessel end actuator that facilitates quick and easy connection of the vessel end to the connection ring, thereby reducing the time and skill required to perform the procedure; and 8) providing significant clinical applicability, utility, and novelty in a variety of surgical procedures to treat numerous pathological disorders, urological diseases, chronic diseases, and clinical indications, including, but not limited to, varicocele repair, cardiovascular surgery, varicocele, erectile dysfunction, testosterone deficiency (hypogonadism), infertility, Nutcracker syndrome, benign prostatic hyperplasia (BPH), testicular pain, testicular atrophy, testicular cancer, bladder cancer, prostate cancer, pelvic congestion, pelvic congestion syndrome, pelvic pain, ovarian cancer, polycystic ovary syndrome, endometriosis, and / or uterine fibroids.

[0021]

[0032] In some embodiments, any of the systems, methods, and devices described herein may be used to treat an indication including BPH. In some embodiments, any of the systems, methods, and devices described herein may be used to treat an indication including prostate cancer. In some embodiments, any of the systems, methods, and devices described herein may be used to treat an indication including male infertility. In some embodiments, any of the systems, methods, and devices described herein may be used to treat an indication including androgen deprivation therapy. In some embodiments, any of the systems, methods, and devices described herein may be used to treat an indication including uterine fibroids. In some embodiments, any of the systems, methods, and devices described herein may be used to treat an indication including endometriosis. In some embodiments, any of the systems, methods, and devices described herein may be used to treat an indication including polycystic ovary syndrome.

[0022]

[0033] Disclosed herein are various embodiments of systems, methods, and devices that make anastomosis easier and more time-efficient by enabling the use of anastomotic couplers in microsurgery and laparoscopic procedures. The simplification of the anastomosis procedure minimizes the required operator skill, reduces the amount of distraction required, and helps reduce surgeon fatigue during lengthy and complex surgical procedures.

[0023]

[0034] This disclosure and the accompanying drawings are intended to describe some, but not necessarily all, examples or embodiments and are not intended to limit the scope of the disclosure in any way. The drawings referred to herein may not be to scale and may be exaggerated for illustrative purposes. In the following description of several different example embodiments, corresponding features are designated by the same reference numerals.

[0024]

[0035] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic operator of a surgical instrument. The term "proximal" refers to the location of an element closer to a human or robotic operator of a surgical instrument and farther from the surgical end effector of the surgical instrument. The term "distal" refers to the location of an element closer to a surgical end effector of a surgical instrument and farther from the human or robotic operator of the surgical instrument. Additionally, terms such as "upper," "lower," "horizontal," "vertical," "bottom," and "top" are relative terms used to further clarify the description of the drawings that follow. Accordingly, the terms "upper," "lower," "horizontal," "vertical," "bottom," and "top" are not intended to unnecessarily limit the invention(s) described herein.

[0025]

[0036] In general, the present disclosure relates to several systems, methods, and devices for applying anastomotic couplers to perform minimally invasive vascular procedures, particularly for performing anastomoses between hollow tissue structures when access to the tissue site is limited. In some embodiments, the device (sometimes referred to herein for brevity as an anastomosis device, apparatus, or surgical instrument) is configured for applying an anastomotic coupler via a laparoscopic approach and includes a proximal handle portion or interface, a body intermediate shaft assembly extending distally from the handle portion, and an end effector disposed at the tip of the shaft assembly.

[0026]

[0037] For example, FIG. 1A is a schematic illustration of an anastomosis device 100 for performing a laparoscopic anastomosis of a first vessel V1 to a second vessel V2, and FIG. 1B is a schematic illustration of a portion of the device 100 of FIG. 1A showing how the first vessel V1 and the second vessel V2 are coupled to one another via the device 100 of FIG. 1A, according to one embodiment. The device 100 comprises a body 102 coupled to an interface 104 that houses or otherwise couples one or more actuators 106, and an end effector 120 including a first end effector element 122a configured to releasably receive a first coupler element 130a of a coupler 130 and a second end effector element 122b configured to releasably receive a second coupler element 130b of the coupler 130. The device 100 may also optionally comprise an actuation mechanism 140, a locking mechanism 105, and / or a release mechanism 107.

[0027]

[0038] The body 102 comprises an elongated member that may have a length in a range of 4 inches to 30 inches, including all subranges and values ​​therebetween (e.g., 4 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 15 inches, 18 inches, 21 inches, 25 inches, 28 inches, or 30 inches). In some embodiments, the body 102 may have a length of at least 8 inches. The body 102 may be formed from any suitable material, such as stainless steel, alloys, etc. The body 102 may define a longitudinal channel in which various components of the device 100 may be disposed. In some embodiments, a sheath 10 may be disposed around the body 102. The sheath 10 may be formed from any suitable material, such as stainless steel, alloys, plastic, etc. A user may be able to, for example, extend or retract an end effector at least partially within the sheath 10 by, for example, selectively moving the body 102 axially within the sheath 102.

[0028]

[0039] The proximal end of body 102 is coupled to interface 104 such that an elongated body extends longitudinally therefrom. Interface 104 may comprise a housing that may have an ergonomic shape for a user to grasp. For example, in some embodiments, interface 104 may be formed in the shape of a handle or may include a finger or hand grip to facilitate a user grasping and manipulating interface 104 to perform a laparoscopic anastomosis of two vessels or any other tubular structure.

[0029]

[0040] One or more actuators 106 may be coupled to the interface 104. In some embodiments, the actuators 106 may include a push button, a pull lever, a trigger configured to be engaged by a user's index and / or middle fingers, a thumb trigger configured to be engaged or otherwise operated by a user's thumb, a slide actuator, a clip, a lever, a rotary knob, a scissor lever or another first level, any other suitable actuator, and / or combinations thereof. In some embodiments, the device 100 may also include an actuation mechanism 140 extending through one or more channels defined through the body 102 and operably coupling the actuators 106 to the end effector 120 to, for example, cause a corresponding movement or displacement of the end effector 120. Such an actuation mechanism 140 may include, for example, a rod, a gear, a rack and pinion, a piston, a lever, a band, a string, a rope, a pulley, etc.

[0030]

[0041] For example, the one or more actuators 106 may be configured to articulate the first end effector element 122a and the second end effector element 122b in one or more directions about the tip of the body 102 to move them apart and / or toward each other. For example, the one or more actuators 106 can be configured to move the first end effector element 122a and the second end effector element 122b between a first configuration in which the two end effector elements 122a and 122b are spaced apart from each other and a second configuration in which the two end effector elements 122a and 122b are adjacent to each other. In the second configuration, the two end effector elements 122a and 122b can be configured to couple the first coupler element 130a and the second coupler element 130b. In some embodiments, the first and second end effector elements 122a and 122b can also be configured to be in an intermediate configuration, e.g., between the first and second configurations. The one or more actuators 106 can be coupled to an actuation mechanism 107 that can be driven by the one or more actuators 106 to cause movement of the first and second end effector elements 122 a and 122 b. In some embodiments, the actuators 106 are configured to articulate one or more portions of the end effector 120 (e.g., the first end effector element 122 a and / or the second end effector element 122 b) in a single direction (e.g., a first direction), while in other embodiments, the actuators 106 can be configured to articulate one or more portions of the end effector 120 in multiple directions (e.g., a first direction and a second direction). For example, the first direction can include rotating the tips of the first and second end effector elements 122 a / b toward or away from each other about the tip of the body portion 102, as shown by arrow A in FIG. 1B . Additionally or essentially, the second direction may include articulating the first and second end effectors 122a / b in a direction substantially perpendicular to the first direction, as shown by arrow B in FIG. 1B, thereby allowing for flexible positioning of the end effector 120 at a desired location within the body of the patient P.In some embodiments, the first actuator 106 can be configured to rotate the first end effector element 122a about a first axis, e.g., to move the first end effector element 122a closer to or farther away from the second end effector element 122b. In some embodiments, the second actuator 106 can be configured to pivot the second end effector element 122b about a second axis, e.g., to move the second end effector element 122b closer to or farther away from the first end effector element 122a. In some embodiments, the first axis about which the first end effector element 122a is configured to rotate and the second axis about which the second end effector element 122b is configured to rotate can be the same axis, while in other embodiments, the two axes can be offset from one another. In some embodiments, the first and second end effector elements 122a and 122b may also pivot about a third axis or be angled from the longitudinal axis of the body to, for example, position the first and second end effector elements 122a and 122b to provide a better view for a user (e.g., a surgeon).

[0031]

[0042] For example, in some embodiments, movement in a first direction includes articulating the first and / or second end effector elements 122a / b within a plane extending along the longitudinal axis of the end effector 120, and movement in a second direction includes articulating the first and second end effector elements 122a / b around a plane extending along the longitudinal axis.

[0032]

[0043] As shown in FIGS. 1A and 1B, the end effector 120 is coupled to the distal end of the elongate body 102. The end effector 120 includes a first end effector element 122a defining a first receiving portion with structure to retain a first coupler element 130a of the coupler 130, and a second end effector element 122b defining a second receiving portion with structure to retain a second coupler element 130b of the coupler 130. The coupler 130 may comprise any suitable coupler usable to connect two tubes or any other tubular tissue structures. For example, the first coupler element 130a may comprise a ring-shaped member defining a central opening configured to receive an axial end of the first tube V1. Similarly, the second coupler element 130b may comprise a ring-shaped member to receive an axial end of the second tube V2. In some embodiments, the second coupler element 130b may be a mirror image of the first coupler element 130a.

[0033]

[0044] In some embodiments, the first and second coupler elements 130 a / b can each include an interlocking feature, such as a mating snap-fit ​​feature (e.g., a pin, groove, slot, ledge, protrusion, notch, indentation, detent, etc.), such that the first coupler element 130 a couples with the second coupler element 130 b when corresponding surfaces of the first and second coupler elements 130 a / b are pressed together. This also brings corresponding axial ends of the first tube V1 and the second tube V2 into contact with each other, thereby enabling coupling between the tubes V1 and V2. In some embodiments, the axial ends of the first and second tubes V1 and V2 can be spread apart prior to coupling.

[0034]

[0045] In some embodiments, the first end effector element 122a and the second end effector element 122b can be implemented as jaws or clamp arms that are articulatably mounted about their respective proximal ends, allowing the proximal ends of the first and second end effector elements 122a / b to remain close to each other during operation, while the distal ends of the first and second end effector elements 122a / b can be selectively moved apart to open and close the end effector 120. For example, the end effector 120 may be configured to move between a first configuration in which at least a portion (e.g., its tip) of the first end effector element 122a is spaced apart from a corresponding portion (e.g., its corresponding tip) of the second end effector element 122b, thereby spaced apart from the second coupler element 130b, and a second configuration in which at least a portion of the first end effector element 122a is proximate to a corresponding portion of the second end effector element 122b, thereby coupling the first coupler element 130a to the second coupler element 130b (e.g., as shown in FIG. 1B) to couple the first tube V1 to the second tube V2.

[0035]

[0046] In some embodiments, the first and second end effector elements 122 a / b may be laterally spaced a fixed or variable distance along their lengths in the first configuration. The first end effector element 122 a and / or the second end effector element 122 b may then be laterally displaced toward each other until the first and second coupler elements 130 a / b are both coupled in the second configuration. The lateral displacement may be a lateral translation.

[0036]

[0047] In some embodiments, the proximal ends of the first end effector element 122 a and the second end effector element 122 b may be coupled to the distal end of the elongate body 102. The first coupler element 130 a and the second coupler element 130 b may be removably coupled to the corresponding distal ends of the first end effector element 122 a and the second end effector element 122 b, respectively. Furthermore, the first and second end effector elements 122 a / b may be configured to move the end effector 120 between the first and second configurations by articulating them about the distal end of the elongate body 102 in a first direction (e.g., as shown by arrow A). In some embodiments, the proximal ends of the first and second end effector elements 122 a / b may be coupled to the distal end of the elongate body 102 via an actuation mechanism 140, which may comprise a structure that enables articulation of the first and second effector elements 122 a / b, as described above.

[0037]

[0048] In some embodiments, the end effector 120 may also include an intermediate member coupling the first and second end effector elements 122 a / b to the elongate body 102. For example, as shown in FIGS. 1A and 1B, the end effector 120 may comprise a first intermediate member 123 a coupling the first end effector element 122 a to the elongate body 102 and a second intermediate member 123 b coupling the second end effector element 122 b to the elongate body 102. In some embodiments, the first and second intermediate members 123 a / b may be configured to articulate about their proximal ends (i.e., about the elongate body 102), and the first and second end effector elements 122 a / b may be configured to articulate at their respective proximal ends about the distal ends of the first and second intermediate members 123 a / b. In this manner, the first and second intermediate members 123 a / b may enable the first and second end effector elements 122 a / b to have multiple degrees of freedom, facilitating manipulation of the end effector 120. In some embodiments, the tips of the first and second end effector elements 122 a / b may be coupled to one another and configured to articulate about their respective tips. In such embodiments, the end effector 120 may open and close like a cage to perform vascular anastomosis. Such embodiments are described in further detail with reference to FIGS. 2A through 11C.

[0038]

[0049] In some embodiments, actuation mechanism 140 may be configured to move first and second end effector elements 122 a / b to an intermediate configuration in which at least a portion of first end effector element 122 a (e.g., its tip) is positioned proximate to a corresponding portion of second end effector element 122 b but there is a gap therebetween such that first coupler element 130 a is not coupled to second coupler element 130 b, thereby reducing the lateral width of end effector 120 and facilitating insertion into the body of patient P through a small incision (e.g., less than 25 mm in diameter), which may reduce injury and enable faster healing.

[0039]

[0050] Any suitable actuation mechanism 140 may be used. In some embodiments, the actuation mechanism 140 may include a first linkage arm coupled to the first end effector element 122a and a second linkage arm coupled to the second end effector element 122b. The first and second linkage arms may each include a central hinge, such that moving a proximal end of each of the first and second linkage arms proximate a corresponding distal end of the first and second linkage arms articulates the first and second linkage arms away from each other about their respective central hinges to selectively move the end effector from a first configuration to a second configuration. In other words, the first and second linkage arms may function as scissor arms to move the first and second end effector elements 122a / b between the first and second configurations.

[0040]

[0051] In some embodiments, actuation mechanism 140 may include at least one pulley coupled to a corresponding one of first end effector element 122a and / or second end effector element 122b. At least one tether may be coupled to the at least one pulley. The at least one tether may be configured to be longitudinally displaced (e.g., by a user upon engagement of a corresponding actuator 106). The tether encircles the pulley, and displacing the tether rotates the at least one pulley to move the end effector between the first and second configurations.

[0041]

[0052] In some embodiments, actuation mechanism 140 may include at least one rod coupled to a corresponding one of first end effector element 122 a and second end effector element 122 b and configured to rotate to move end effector 120 between the first and second configurations. For example, at least one rod may be coupled to a corresponding one of first end effector element 122 a and / or second end effector element 122 b proximate a radially outer edge of the corresponding one of first end effector element 122 a or second end effector element 122 b. Thus, rotating the rod moves radially outer edges of first and second end effector elements 122 a / b distal to the axial ends of the rod toward or away from each other, thereby moving end effector 120 between the first and second configurations.

[0042]

[0053] In some embodiments, the end effector 120 may be at least partially retracted within the optional sheath 10, or the sheath 10 may be axially displaced relative to the end effector 120 such that the inner surface of the distal end of the sheath 10 covers or surrounds the outer surfaces of the first and second end effector elements 122 a / b, respectively. In some embodiments, the sheath 10 may have a diameter less than or approximately equal to the maximum lateral width of the end effector 120 such that axial displacement of the sheath 10 relative to the end effector 120 (or retraction of the end effector 120 within the sheath 10) forces the first and second end effector elements 122 a / b into the second configuration.

[0043]

[0054] In some embodiments, at least one closure element may be coupled to the first end effector element 122a and the second end effector element 122b and configured to urge the end effector into the second configuration. The closure element may include, for example, a mechanical linkage, a rope wire, a thread, a suture, a filament, an extrusion, a spring, a rubber band, a bungee cord, any other suitable closure element, or any combination thereof. The closure element may be configured to bias the first end effector element 122a and the second end effector element 122b toward each other to facilitate moving the end effector 120 from the first configuration to the second configuration. In some embodiments, a resilient element may additionally or alternatively be coupled to the first end effector element 122a and / or the second end effector element 122b and configured to urge the end effector 120 into the open configuration. The resilient element may include, for example, a spring, a resilient plate (e.g., a NITNOL plate), a mechanical linkage, a rope wire, a thread, a suture, a filament, an extrusion, or other biasing member, and may be configured to bias the first and / or second end effector elements 122a / b into the first configuration.

[0044]

[0055] In some embodiments, each of the first and second end effector elements 122a, 122b may be configured to move between the first and second configurations by twisting along a respective axis. For example, the first and second end effector elements 122a / b may each include an actuation skeleton that may be in the form of a continuous structure with a helical tendon wire routing. Such a structure may include a set of disks along which push-pull tendon wires are routed in a helical fashion around the structure's major axis. In other embodiments, the skeleton may be braided. The actuation mechanism 140 may be configured to engage the tendon wires to cause the skeleton of each of the first and second end effector elements 122 a / b to undergo not only pure rotation but also torsion about a primary skeleton axis, thereby moving at least the tips of the first and second end effector elements 122 a / b away from each other and moving the end effector 120 to a first configuration, or to move the first and second end effector elements 122 a / b closer to each other and moving the end effector 120 to a second configuration. Such compound motions may not only bend the first and second end effector elements 122 a / b away from each other, thereby separating the distal ends of the first and second end effector elements 122 a / b, but may also rotate the first and second end effectors about their respective longitudinal axes, thereby exposing the inner surfaces and ultimately the coupled first and second coupler elements 130 a / b.

[0045]

[0056] In some embodiments, the first end effector element 122a and the second end effector element 122b may each include alignment features defined on their corresponding surfaces. The alignment features may be configured to align the first and second end effector elements 122a / b as the end effector 120 moves to the second configuration, thereby facilitating, for example, alignment of the first coupler element 130a with the second coupler element 130b. Such alignment features may include, but are not limited to, one or more notches, lips, grooves, indentations, detents, protrusions, or other mating features that aid in coarse and fine alignment of the first coupler element 130a with the second coupler element 130b during actuation of the device 100 to move the end effector 120 from the first to the second configuration. Additionally, the end effector 120 may include one or more gripping portions, grooves, surface modifications, locking mechanisms, or any combination thereof, to facilitate controlled anastomosis.

[0046]

[0057] Optionally, in some embodiments, the device 100 may include a locking mechanism 105 that may be configured to selectively lock the coupler 130 (e.g., the first coupler element 130a and / or the second coupler element 130b) to the end effector 122. Optionally, in some embodiments, the device 100 may include a release mechanism 107 that, for example, releases the first coupler element 130a and / or the second coupler element 130b from the end effector 120. In some embodiments, the receivers of the first and second end effector elements 122a / b may include cutouts, cavities, slots, etc. that are shaped and sized to snugly receive (e.g., via a friction fit) the first and second coupler elements 130a / b. In some embodiments, the first and second coupler elements 130a / b may be selectively locked or released from their respective receivers via, for example, the locking mechanism 105 and / or the release mechanism 107. For example, release mechanism 107 may be configured to be selectively actuated to release coupler 130 from end effector 120 in the second configuration. In some embodiments, release mechanism 107 is coupled to locking mechanism 105 such that movement of locking mechanism 105 can, for example, drive movement of release mechanism 107 to release coupler 130. Alternatively, device 100 may not include locking mechanism 105 and release mechanism 107. In such a case, a surgeon may use a separate instrument (e.g., pliers, hook, etc.) to detach coupler elements 130a / b from end effector elements 122a / 122b.

[0047]

[0058] Any suitable securing mechanism 105 may be used. In some embodiments, at least one of the first coupler element 130a and the second coupler element 130b may define a circumferential groove in its radially outer surface, e.g., in the radial direction of the first and / or second coupler elements 130a / b, around their circumference. In such embodiments, the securing mechanism 105 may include a string (e.g., twine, rope, thread, band, chain, etc.) disposed in a portion of the circumferential groove to secure the first coupler element 130a or the second coupler element 130b.

[0048]

[0059] FIG. 2 shows an exemplary schematic of a laparoscopic anastomosis device, followed by FIGS. 3A-3H showing views of the end effector of the device of FIG. 2 connecting a first tube to a second tube, according to various embodiments.

[0049]

[0060] 2 illustrates a laparoscopic anastomosis device 200 according to one embodiment. A proximal end 201 of the device 200 includes an actuator 202 interface for actuation by, for example, a user. A device body 203 serves as a connection point between the proximal and distal ends of the device 200, embodying a minimally invasive device form factor. An end effector 204 of the device 200 is connected to the proximal end (including the interface 201 and actuator 202) through the body 203, enabling various operations within an appropriate range of motion.

[0050]

[0061] 3A shows an exemplary end effector 304 through the steps of use of one embodiment. In this embodiment, the tip of the device, body 205, and end effector 304 may include internal channels 209 and 210 that are used to guide a translatable tube actuator 206 along the axis of the internal channels 209 and 210. The tube actuator 206 may be used to grasp the end of the tube and couple it to anastomotic coupling rings 211 and 212 that may be present on corresponding jaws 207 and 208. The end effector 204 may include jaws 207 and 208 and articulation drive members 213 and 214 for the corresponding jaws 207 and 208. The tip of the device may include two jaws 207 and 208 that may be connected to the distal end of the device by a distal articulation drive member 215. The distal articulation drive member 215 may allow for a wide range of mobility necessary to accommodate, for example, three device positions or configurations for successful anastomosis.

[0051]

[0062] More broadly, the body 205 (also referred to herein as "elongate body 205") comprises an elongate structure extending longitudinally from the interface 201. The elongate body 205 may define an inner channel 209 along its longitudinal axis. The tube actuator 206 may be configured to be axially displaced or translated through the inner channel 209 to selectively protrude through the end effector 204, e.g., by being distally displaced relative to the elongate body 205 as described herein. Although not shown, in some embodiments, an outer sheath may be disposed around the elongate body 205.

[0052]

[0063] The end effector 204 is coupled to the tip of the elongate body 205 and includes a first end effector element 207 (also referred to herein as the "first jaw 207"), a second end effector element 208 (also referred to herein as the "second jaw 208"), a first articulation drive member 213, a second articulation drive member 214, and in some embodiments, a distal articulation drive member 215 (collectively referred to herein as the "device articulations 214, 213, 215"). The first end effector element 207 defines a first receiving portion, cavity, or opening configured to hold a coupling ring 211 (also referred to herein as “first coupler element 211”), and the second end effector element 208 defines a second receiving portion, cavity, or opening configured to hold a coupling ring 212 (also referred to herein as “second coupler element 212”). The first and second coupler elements 211 and 212 form two parts that are engaged with each other to form a coupler. A tip of the second end effector element 207 can be coupled to a tip of the first end effector element 208 to enable the first and second end effector elements 207 and 208 to be articulated about their respective tips. For example, in some embodiments, the distal articulation drive member 215 can couple a tip of the first end effector element 207 to the second end effector element 208, thereby articulating the tips of the first and second end effector elements 207 and 208 about one another. In some embodiments, the distal articulation drive member 215 can be configured to allow translation and articulation of the first and second end effector elements 207, 208. For example, the distal articulation drive member 215 can include a longitudinal slot having a pin disposed therein that couples the first end effector element 207 to the second end effector element 208. The pin can move from an open configuration to a closed configuration by rotating the jaws of the first and second end effector elements 207 and 208 about one another. Further, the pins may be configured to slide the first and second end effector elements 207 and 208 towards (or away from) each other, for example, by sliding within longitudinal slots in the closed configuration of the end effector 204.This may facilitate alignment of the coupler elements 211 and 212 disposed on the first and second end effector elements 207 and 208 relative to each other, as previously described herein, and may facilitate coupling of the coupler elements 211 and 212 and anastomosis of the axial ends of the two tubes V1 and V2 by moving the first and second end effector elements 207 and 208, and thus the coupler elements 211 and 212, towards each other.

[0053]

[0064] The first articulation drive member 213 couples a proximal end of the first end effector 207 to the elongate body 205, and the second articulation drive member 214 couples a proximal end of the second end effector element 208 to the elongate body 205. For example, the proximal ends of the first and second articulation drive members 213 and 214 may be coupled to an outer end surface or end of the elongate body 205 and configured to articulate about their respective distal ends. The distal ends of the first and second articulation drive members 213 and 214 may be coupled to the proximal ends of the first and second end effector elements 207 and 208, respectively, thereby enabling the first and second end effector elements 207 and 208 to articulate about the corresponding distal ends of the first and second articulation drive members 213 and 214, respectively. In this manner, the combination of the first and second articulation drive members 213 and 214, which can rotate at their proximal ends, the first and second end effector elements 207 and 208, which can rotate about their respective proximal ends at their respective distal ends, and the distal articulation drive member 215, forms a cage-like structure with multiple degrees of freedom that can be opened, closed, and / or moved to different angular positions to facilitate insertion of the axial ends of the vessels V1 and V2 into and coupling of the first and second coupler elements 211 and 212 for anastomosing the distal ends of the vessels V1 and V2.

[0054]

[0065] In some embodiments, the first and second articulation drive members 213 and 214 may be coupled to the elongate body 205 via a connecting element or linkage configured to allow sliding or translation of the first and second articulation drive members 213 and 214 that couple the end effector 204 to the elongate body 205 along the side of the elongate body 205. This may facilitate rotation and translation of the end effector 204 in various directions by allowing the first and second articulation drive members 213 and 214, and thus the first and second end effector elements 207 and 208, to translate proximally or distally. In various embodiments, the connecting element or linkage may comprise a slot defined in a sidewall of the elongate body 205 and a sliding linkage coupled to the slot or a coupler within the slot to provide an increased range of motion.

[0055]

[0066] The end effector 204 can be configured to move between various positional configurations. For example, in some embodiments, the end effector 204 can be configured to move between (i) a first configuration that positions the first end effector element 207 away from the second end effector element 208 in a first position where the first and second articulation drive members 213 and 214 receive a first axial end of the first tube V1 in the first coupler element 211; and (ii) a second configuration that positions the first end effector element 207 away from the second end effector element 208 in a second position where the first and second articulation drive members 213 and 214 receive a second axial end of the second tube V2 in the second coupler element 212. and (iii) a third configuration in which the first and second articulation drive members 213 position at least a portion of the first end effector element 207 adjacent to a corresponding portion of the second end effector element 208, thereby coupling the first coupler element 211 to the second coupler element 212 and connecting the first tube V1 to the second tube V2. In some embodiments, the end effector 204 is also configured to move to an intermediate configuration in which at least a portion of the first end effector element 211 is adjacent to a corresponding portion of the second end effector element 212, but provides a gap therebetween so that the first coupler element 211 is not coupled to the second coupler element 212. This intermediate configuration may facilitate, for example, insertion of the end effector 204 into a targeted surgical site within a patient's body.

[0056]

[0067] In some embodiments, in a first configuration, at least a portion of the first end effector element 207 is substantially perpendicular to the axis of the elongate body 205, and in a second configuration, at least a portion of the second end effector element 208 is substantially perpendicular to the axis of the elongate body 205. As used herein, the term "substantially perpendicular" means within + / - 10 degrees of perpendicular, or at an angle within a range of 80-90 degrees relative to the axis of the elongate body 205. For example, a first step in a device workflow may include positioning the first jaw 207 perpendicular to the axis of the tube actuator 206, as shown in FIG. 3B. To enable this configuration, device articulations 214, 213, and 215 are appropriately articulated. For example, the distal end of the first articulation drive member 213 may be articulated about the proximal end of the elongate body 205 toward the axis thereof, and the distal end of the second articulation drive member 214 may be articulated about the proximal end of the elongate body 205 away from the axis thereof, such that at least a portion of the first end effector element 207 is oriented substantially perpendicular to the axis of the elongate body 205. This allows the tube actuator 206 to be advanced through the first coupling ring 211. For example, the first coupler element 211 may be positioned within the receiver such that, in the first configuration, an opening of the first coupler element 211 is substantially axially aligned with the elongate body 205. After passing through this coupling ring 211, the tube actuator 206 can be advanced into the lumen through the end of the first tube V1.

[0057]

[0068] Various positions of the end effector 204 may be achieved by controlled actuation of the articulating joint using, for example, a tether, rope wire, mechanical linkage, electric motor, electroactive polymer, magnet, push rod, translation pin, rivet, svalve joint, rotation pin, shaft, bearing, sleeve bearing, and / or combinations thereof. For example, in some embodiments, the device 200 may include a first tether having a first end coupled to the first articulation drive member 213 and a second tether having a second end coupled to the second articulation drive member 214. The first tether and the second tether may move independently to control the movement of the first and second articulation drive members between the first, second, and / or third configurations. In other embodiments, the device 200 may include a tether having a first end coupled to the first articulation drive member 213 and a second end coupled to the second articulation drive member 214.

[0058]

[0069] 3C , the tube actuator 206 is actuated to engage the lumen of the first tube V1. This provides a robust connection between the first tube V1 and the tube actuator 206, allowing the first tube V1 to pass through the coupling ring 211. The tube actuator 206 may be configured to receive the axial end of the first tube V1 within the first coupler element 211 in the first configuration. For example, the tube actuator 206 may be configured to translate through the first coupler element 211 in the first configuration. The tube actuator 206 may be configured to grasp, secure, clamp, or otherwise capture the axial end of the first tube V1 and pull it back through the opening in the first coupler element 211. The tube actuator 206 can engage the lumen of the first tube V1 using a mechanical mechanism, such as, but not limited to, an expanding basket, an expanding wire, a flaring mechanism, negative pressure, vacuum, suction, barbs, hooks, tacks, or the like. The tube actuator 206 then retracts the vessel V1 through the connection ring 212 and into the body interior channel 209, thereby advancing the vessel V1 with the tube actuator 206. Once the end of the first vessel V1 has successfully passed through the connection ring 212, the tube actuator 206 is further actuated to facilitate connection of the vessel V1 to the connection ring 212. Connection of the tube end of the first vessel V1 to the connection ring 212 may be achieved by everting or expanding the vessel end. This everting of the vessel end may be facilitated by the tube actuator 206 via mechanical, hydraulic, or pneumatic expansion of the tube actuator and connection of the vessel. Once the vessel V1 is connected to the connection ring 212, the tube actuator 206 may be relaxed and retracted (e.g., fully or partially) within the body interior channel 209 after the connection between the vessel V1 and the tube actuator 206 is severed. For example, the first coupler element 211 may include a fixation member, such as a pin, hook, indentation, detent, or any other fixation member, on its inner surface. The axial end of the first tube V1 can be inverted, for example, so that it can be fixed to a fixing member by penetrating the wall of the first tube V1 so that the axial end of the first tube V1 remains fixed to the first coupler element 207 when the tube actuator 206 is retracted from the first tube V1.

[0059]

[0070] Additionally, the above configurations and positions may be controlled from the proximal end of the device by a suitable linkage mechanism that passes through body 205.

[0060]

[0071] A similar process may be repeated for the second tube V2, as shown in Figures 3D and 3E. For example, the distal end of the first articulation drive member 213 may be articulated about its proximal end away from the axis of the elongate body 205, and the distal end of the second articulation drive member 214 may be articulated about its proximal end toward the axis of the elongate body 205 to orient at least a portion of the second end effector element 208 generally perpendicular to the axis of the elongate body 205 and to align the opening of the second coupler element 212 generally axially with the axis of the elongate body 205. In the second configuration, the tube actuator 206 may be configured to receive the axial end of the second tube V2 within the second coupler element 212 and couple the axial end of the second tube V2 to the second coupler element 212, as described for the first configuration. Once attachment of the second tube is complete, both tubes are attached to their respective anastomotic coupling rings. The end effector 204 may be articulated to bring both jaws 207 and 208 together by moving the end effector 204 in the third configuration. One or more additional actuators, such as, for example, tethers, ropes, wires, or other actuators, may be coupled to the first and / or second articulation drive members 213 and 214 or the first and / or second end effector elements 207 and 208 and configured to move the distal ends of the first and second articulation drive members 213 and 214 toward each other. This causes the proximal ends of the first and second end effector elements 207 and 208 to be displaced toward each other by articulating the distal ends of the first and second end effector elements 207 and 208 about the distal articulation drive member 215 until the end effector 204 closes. This action couples the coupler elements 211 and 213, as shown in FIG. 3F.

[0061]

[0072] 3G and 3H, tubing actuator 206 may then be advanced through distal channel 210 to separate the anastomosed tubing line AL. As previously described herein, first end effector element 207 defines first channel 207a and second end effector element 208 defines second channel 208a that communicates with openings defined in first and second end effector elements 207 and 208 that retain first and second coupler elements 211 and 212, thereby allowing tubing actuator 206 to be moved axially within channels 207a / b until the end of tubing actuator 206 contacts coupler elements 211 and 212 in the third configuration. Distal articulation drive member 215 defines opening 217 that communicates with channels 207a / b in the third configuration. Continued displacement of the tube actuator 206 through channels 207a and 208a pushes the interconnected first and second coupler elements 211 and 212 out of their respective openings, toward and through opening 217, until the coupler elements 211 and 212 are detached from the end effector 204.

[0062]

[0073] An example embodiment of a laparoscopic anastomosis device 300 and steps for creating an anastomosis are shown in FIGS. 4A through 4F. The laparoscopic device shown in FIGS. 4A through 4F can be structurally and / or functionally similar to other devices described herein, including, for example, the devices described with reference to FIGS. 3A through 3H. FIG. 4A shows a perspective view of the end effectors in a collapsed state that allows passage through a small opening in the device. Each end effector can include a jaw 302, a coupler element 303, and an articulation drive member 304. Furthermore, the two end effectors can be coupled at their distal ends 301 using one or more coupling means, such as, but not limited to, a bail pin, a rope wire, a mechanical linkage, a sliding linkage, a living hinge, a hinge mechanism, a magnetic coupling, an electromagnetic coupling, or the like. In some embodiments, the distal end 301 can be configured to allow articulation as the jaw 302 elements translate. For example, the distal end may include a longitudinal slot within which a pin is disposed that couples a first jaw element to a second jaw element of the jaws 302. The pin may facilitate rotation of the jaw elements of the jaws 302 about each other from an open configuration to a closed configuration. Additionally, the pin may slide the elements of the jaws 302 toward (or away from) each other, for example, by sliding within the longitudinal slot in the closed configuration of the jaws 302. This may align the coupler elements 303 disposed on each jaw element with each other and permit movement of the jaw elements 302, and thus the coupler elements 303, relative to each other to couple the coupler elements and facilitate anastomosis of the axial ends of the two vessels, as described previously herein.

[0063]

[0074] 4B and 4C provide perspective views illustrating example positions for advancing the tube actuator 305 through the coupling ring (coupler element) 303 to engage the tube axial end with the tube actuator or transition from the tube actuator and tube to the tube and coupler element connection. The articulation drive member 304 comprising the end effector may be connected to the distal end of the elongate body using a mechanical linkage 308. A detailed view of such a mechanical linkage 308 is shown in FIG. 4C. For example, in some embodiments, the mechanical linkage 308 may be configured to allow the articulation drive member coupling the end effector 304 to the device body 305 to slide or translate along the side of the device body 305. This may allow the articulation drive members of the end effector 304 to be independently translated proximally or distally to facilitate rotation and translation of the end effector 304 in various directions. In various embodiments, the mechanical linkage 308 may comprise a slot defined in a sidewall of the device body 305 and a sliding linkage that couples to the slot or a coupler within the slot to provide a range of motion.

[0064]

[0075] 4D is a perspective view showing another example position of a laparoscopic anastomosis device in which first and second end effector elements are brought close to one another to allow for the connection of two tubes, thereby allowing for the connection of a first connecting element to a second connecting element, where the end effector elements allow the end of the tube to be threaded through opening 316 in the end effector elements to allow connection with connecting element 303.

[0065]

[0076] Figure 4E illustrates an example of a tube actuator 305 that can be used to disconnect linking element 303 from the rest of the laparoscopic anastomosis device. Figure 4F illustrates an example embodiment of linking elements 321 and 322 in a mated configuration.

[0066]

[0077] Linking elements 321 and 322 comprise annular bodies with a plurality of pins, with the two linking elements having a plurality of holes such that the pins align with the holes as the two linking elements are brought closer together. The annular bodies and pins may comprise, for example, plastic, metal, 3D printed polymer, biodegradable material, or a combination thereof.

[0067]

[0078] 5A and 5B show a flowchart of a method 10 of using an example device or surgical instrument to complete an anastomosis of one vessel to another vessel, according to an embodiment. The method may include dissecting tissue to isolate a first tubular tissue structure; ligating the first tubular tissue structure; dissecting tissue to isolate a second tubular tissue structure; and ligating the second tubular tissue structure. Process 10 may also include closing at least a portion of the first and second tubular tissue structures to prevent bleeding.

[0068]

[0079] The first and second clamp arms are movable to an open configuration. Method 10 may also include passing at least a portion of the first tubular tissue structure through a first coupling ring of a first clamp arm of the surgical instrument and passing at least a portion of the second tubular tissue structure through a second coupling ring of a second clamp arm of the surgical instrument. Method 10 may also include changing the configuration of the first and second clamp arms to securely join the first and second tubular tissue structures by securing at least a portion of the first and second tubular tissue structures to at least a portion of the first and second clamp arms. Changing the configuration of the end effector of the surgical instrument may space the first and second tubular tissue structures from a distal side of the surgical instrument. Changing the configuration of the first and second clamp arms may move the clamp arms to a closed configuration, space the surgical instrument from the intended surgical site. The first and second tubular tissue structures may be open, allowing fluid communication therebetween.

[0069]

[0080] For example, complete closure of the clamp arms of any of the end effectors described herein may be desirable because incomplete closure can potentially lead to leakage, clotting, and bleeding. The clamp arms may be configured to fit together to overcome frictional forces associated with the mating of coupler rings, for example, when pins on the rings must slide into corresponding holes. The closure force may be increased by adding elements to the end effector. Such elements include, for example, a sheath (e.g., sheath 10, FIG. 1B ), which may be used to externally compress the clamp arms together. In some embodiments, a mechanical linkage or pull wire inside the clamp arms may be used to bring the two clamp arms closer together. In some embodiments, elements suitable for closing the two clamp arms include compression using magnets, electromagnets, pneumatic and / or hydraulic elements. Additionally or alternatively, the clamp arms may include ultrasonic transducers to help overcome frictional forces as the pins on the coupler rings slide into corresponding snap-fit ​​channels or holes.

[0070]

[0081] Expanding further, method 10 may include, for example, at 11, preparing a first tubular tissue structure (e.g., a first vessel) for anastomosis by isolating and ligating the first tubular tissue structure. At 12, preparing a second tubular tissue structure (e.g., a second vessel) for anastomosis by, for example, isolating and ligating the second tubular tissue structure. At 13, preparing a surgical instrument (e.g., device 200), for example, by loading coupling rings 211 and 212 onto end effectors 207 and 208. At 14, introducing the surgical instrument to a surgical site of interest by, for example, making an incision in a patient's body and moving device 200 to an intermediate configuration.

[0071]

[0082] At 15, the outer surgical instrument is configured for mode 1, for example, by moving the end effector 204 to a first configuration, aligning the distal jaw 1 (i.e., the first end effector element 207) perpendicularly to the tube actuator 206 or the inner device. At 16, the tube actuator 206 is advanced through the first end effector element 207 into the first tubular structure. At 17, the first use mode of the tube actuator 206 is activated, causing the tube actuator 206 to advance through the first coupler element 211, secure the end of the first tubular structure, and advance the end into the first coupler element 211. At 18, the second use mode of the tube actuator 206 is activated, causing the tube actuator 206 to evert the end of the first tubular structure and thread the end through the corresponding pin of the first coupler element. At 19, the tube actuator 206 is retracted into the elongate body 205.

[0072]

[0083] At 20, the outer surgical instrument is reconfigured to mode 1, for example, by moving end effector 204 to a second configuration, aligning distal jaw 2 (i.e., second end effector element 208) perpendicularly to tube actuator 206. At 21, tube actuator 206 is advanced through second end effector element 208 into the second tubular structure. At 22, a first use mode of tube actuator 206 is activated, and tube actuator 206 is advanced through second coupler element 212, securing the end of the second tubular structure, and into the end of second coupler element 211. At 23, a second use mode of tube actuator 206 is activated, and tube actuator 206 everts the end of the second tubular structure, threading it through the corresponding pin of the second coupler element. At 24, tube actuator 206 is retracted into elongate body 205.

[0073]

[0084] At 25, the surgical device is configured in mode 3, preparing the end effector 204 for moving to, for example, the third configuration. At 26, mode 3 is activated by moving the end effector 204 to the third configuration, closing the first and second end effector elements 207 and 208, thereby joining the first and second coupler elements 211 and 212. At 27, a tube actuator is advanced through the end effector 204, causing the coupler elements 211 and 212 to move out of the end effector 204. At 28, the surgical instrument is retracted and removed from the targeted surgical site.

[0074]

[0085] 6 shows a perspective view of one embodiment of device 400. Device 400 is substantially similar to devices 200 and 300 described herein above, and includes an elongate body 405, a tube actuator 406 disposed therethrough, and an end effector 404 including a first end effector element 407, a second end effector element 408, a first articulation drive member 413, a second articulation drive member 414, and a distal articulation drive member 415, and has substantially similar structure and function to elongate body 205, tube actuator 206, first end effector element 207, second end effector element 208, first articulation drive member 213, second articulation drive member 214, and distal articulation drive member 215 described herein above. The first and second effector elements 407 and 408 define receptacles 419a and 419b, respectively, into which the first and second coupler elements (e.g., the first and second coupler elements 211 and 212) may be disposed, as previously described herein. The end effectors 407 and 408 also define openings 417 that allow the coupler elements to be removed from the end effector 404 via the tube actuator 406, as previously described herein.

[0075]

[0086] Additionally, an exploded view of device 400 can be seen in FIG. 7. Referring to FIGS. 7-11, device 400 includes first, second, and third actuators 422a / b, 424a / b, and 426a / b configured to cycle end effector 404 through different actuation modes by varying the relative distances of components 407, 408, 413, 414, and 415. As shown in FIGS. 7-11, actuators 422a / b, 424a / b, and 426a / b comprise tethers, but in other embodiments may include any suitable actuators, such as ropes, wires, pulleys, pins, and rods. In the illustrated implementation, this variation in distance is achieved by applying pulling forces to three sets of actuators 422a / b, 424a / b, and 426a / b, shown herein as wires, in different configurations for a total of six wires, three on the right (R) and three on the left (L). The final desired position output, the right cage configuration of the end effector 404, the mid-cage configuration, the left cage configuration of the end effector 404, and the folded cage configuration determine the combination of pulls, i.e., the pulls on one or more of the actuators 422a / b, 424a / b, 426a / b. Pull forces can be categorized as OFF, MED, and ON. OFF represents no force on the desired wire, MED represents the wire being taut, and ON represents the wire being pulled to its maximum possible displacement. Figure 11 breaks down the different combinations of pull forces required from each set of wires to output the desired distal mode.

[0076]

[0087] The first actuators 422a / b (also referred to herein as "distal wires 422a / b") may comprise wires coupled to the first end effector element 407 and the second end effector element 408b by being inserted into slots 421a / b defined in the outer surfaces of the first and second effector elements 407 and 408, respectively. As shown in FIG. 7B, pulling the first actuators 422a / bb articulates the first and second end effector elements 407 and 408 about the distal articulation drive member 415, which in turn articulates the first and second end effector elements 407 and 408 about their respective proximal ends, thereby moving the end effector 404 to the open configuration. The tips and / or distal articulation drive members 415 of the first and second end effector elements 407 and 408, unlike the end effectors 205 and 305, are shaped to form tip stops 416 that limit angular movement of the first and second end effector elements 407 and 408, and thus the end effector 404. For example, the tip stop 416 may comprise angular tips of the first and second end effector elements 407 and 408 that contact each other when the end effector 404 is moved to the third configuration, by moving the proximal ends of the first and second end effector elements 407 and 408 away from each other, thereby preventing the end effector 404 from opening any further. In some embodiments, the tip stop members 416 may be configured to limit articulation by the first and second end effector elements 407 and 408 about their respective tips to an angle α of less than 180 degrees. Thus, tip stop member 416 limits the maximum angle to which end effector elements 408 and 407 can open, for example, to ensure proper alignment, which may advantageously facilitate positioning end effector 404 in a desired orientation in the first and second configurations, as described herein.

[0077]

[0088] 8A and 8B further illustrate the device 400 shown in FIGS. 6, 7A, and 7B by illustrating various mechanical features. Device 400 can be cycled through different modes by moving the distal components so that they are seated more proximally. In this embodiment, this is accomplished with a wire that, when pulled proximally, shortens the distance between proximal components 407, 408, 413, 414, and 415. FIG. 7B displays the same embodiment after wire pulling, showing the engagement of tip stop 416 and the reduction in the distance between end effector elements 407 and 408.

[0078]

[0089] 8A and 8B show second actuators 424a / b coupled to the first and second articulation drive members 413 and 414 and which may include tethers or wires (also referred to herein as "distal stop wires 424a / b"). For example, as shown in FIGS. 8A and 8B, the second actuators 424a / b are coupled to first slots 423a / b defined proximal to the proximal ends of the first and second articulation drive members 413 and 414, respectively. The distal stop wires 424a / b are the most distally found wires, and these wires pull the first and second articulation drive members 413 and 414. When a pulling force is applied to the distal stop wires 424a / b, the movement output depends on which wire is being pulled; the wires may be moved equal distances in opposite directions (L=R), configured to produce a seesaw-like movement of the end effector 404. For example, pulling second actuator 424b while leaving second actuator 424a in place will move end effector 404 to the first configuration shown in FIG. 8B, and vice versa.

[0079]

[0090] 9A-9D illustrate third actuators 426a / b (also referred to herein as "folded mode wires 426a / b") coupled to the first and second articulation drive members 413 and 414 and configured to collapse the first and second end effectors 407 and 408, thereby moving the end effector 404 to the third configuration. The third actuators 426a / b may be depicted as comprising a tether or wire, but may comprise any other actuator described herein. As shown in FIG. 9A, distal ends of the folded mode wires 426a / b are coupled to second slots 425a and 425b defined in the first and second articulation drive members 413 and 414, respectively. The second slots 425a / b may be defined in the first and second articulation drive members 413 and 414 at a location distal to the first slots 423a / b, but in other embodiments may be positioned at any suitable location on the first and second articulation drive members 413 and 414.

[0080]

[0091] The folded mode wires 426 a / b apply a pulling force to the first and second articulation drive members 413 and 414, causing the tips of the first and second articulation drive members 413 and 414 to articulate toward each other, thereby returning the first and second end effector elements 407 and 408 to a folded state when the first and second end effector elements 407 and 408 are in any other mode (e.g., the first or second configuration, or any other orientation). When a pulling force is applied to the folded mode wires 426 a / b, the movement outputs are independent (L≠R), which means that in this embodiment, pulling on either the left or right side does not necessarily affect the opposite side. The second actuators 424a / b apply a pulling force to the first and second articulation drive members 413 and 414, causing these components to oscillate further left or further left depending on which of the left and right second actuators 424a / b is applying more pulling force, thus creating a see-saw effect as described above (L=R). FIGS. 8A and 8B focus on the second actuators 424a / b. In FIG. 8A, the end effectors 407 and 408 are in the collapsed mode prior to applying a pulling force to the second actuators 424a and 424b. As a result, when the left second actuator 424b is pulled (ON), the second articulation drive member 414 articulates radially outward and the first articulation drive member 413 articulates radially inward, thereby moving the first end effector element 407 to a vertical position relative to the elongate body 405. This is equally true when a pulling force is applied to the second actuator 424 a on the right, causing the second end effector element 408 to be oriented perpendicular to the elongate body 405 .

[0081]

[0092] 9A-9D focus on the collapsed mode wires 426 a / b. In FIG. 9A, the first and second articulation drive members 413 and 414 are in the intermediate cage configuration prior to applying a pulling force to the collapsed mode wires 426 a / b. As a result, when a pulling force is applied (ON) to both the right and left collapsed mode wires 426 a / b, an inward bias is applied to the first and second articulation drive members 413 and 414, causing the first and second end effector elements 407 and 408 to close the end effector 404 and move the end effector tail 404 to the collapsed cage configuration, as shown in FIG. 9B-9D.

[0082]

[0093] Figures 10A-10C illustrate the concept of different cage configurations in more detail. Figure 10A shows the end effector 404 in a first configuration (right cage configuration), Figure 10C shows the end effector 404 in a second configuration (left cage configuration), and Figure 10C shows the end effector 404 between the first and second configurations (intermediate cage configuration). Arrows indicate end effector elements 407 and 408 and / or articulation drive members 413 and 414 under tension. In Figures 10A-10C, lines without arrowheads indicate end effector elements 407 and 408 and articulation drive members 413 and 414 under no tension. In some embodiments, the end effector 404 may also include hinge pins disposed at proximal and distal ends of the first and second articulation drive members 413 and 414 and the first and second end effector elements 407 and 408 to couple the first and second end effector elements 413 and 414 to the elongate body 405, couple the distal ends of the first and second end effector elements 407 and 408 to the proximal ends of the first and second end effector elements 407 and 408, and couple the distal ends of the first and second end effector elements 407 and 408 to one another, for example, via the distal articulation drive member 415. In some embodiments, the end effector 404 may also include end stop pins located at any suitable location on the end effector 404. The end stop pins may be configured to limit the angular movement or displacement of the first and second end effector elements 407 and 408 and / or the first and second articulation drive members 413 and 414. This may advantageously prevent the end effector 404 from moving to an orientation in the cage configuration where the collapsed mode wires 426 a / b would prevent the end effector 404 from moving to the collapsed configuration. Figure 11 shows various end effectors 404 in right, middle, and left cage configurations, as well as the first actuators 422 a / b, second actuators 424 a / b, and / or third actuators 426 a / b that are actuated to achieve these configurations.

[0083]

[0094] 12A-12C show perspective views of another embodiment of device 500. Device 500 is substantially similar to device 400 described herein above, and comprises an elongate body 505 substantially similar in structure and function to elongate body 405, tube actuator 405, first end effector element 407, second end effector element 408, first articulation drive member 413, second articulation drive member 414, and distal articulation drive member 415 described herein above, a tube actuator 506 disposed through elongate body 505, and an end effector 504 comprising first end effector element 507, second end effector element 508, first articulation drive member 513, second articulation drive member 514, and distal articulation drive member 515.

[0084]

[0095] Unlike device 400, the end effector 504 of device 500 further comprises alignment features for aligning the first and second end effector elements 507 and 508 with the first and second articulation drive members 513 and 514 for proper closure in the third configuration, and for axially aligning the tube actuator 506 with the first or second coupler element (e.g., the first and second coupler elements 211 and 212) in the first and second configurations. 12A-12C, the first and second articulation drive members 513 and 514 include first alignment features 532 (e.g., pins, protrusions, recesses, detents, slots, cavities, etc.), and the first and second end effector elements 507 and 508 include second alignment features 534 (e.g., pins, protrusions, recesses, detents, slots, cavities, etc.) configured to mate with the corresponding first alignment features 532. The first and second alignment features 532 are configured to facilitate properly aligned closure of the end effector elements 507 and 508 and the first and second articulation drive members 513 and 514 when in the folded state configuration, i.e., the third configuration. In this manner, the first and second alignment features 532 and 534 facilitate alignment and mating of the first coupler element coupled to the first end effector element 507 and the second coupler element coupled to the second end effector element 508 in the third configuration.

[0085]

[0096] The end effector 504 also includes a first end effector alignment member 536a disposed on the first articulation drive member 513 and configured to align the tube actuator 506 with the first coupler element in the first configuration, and a second end effector alignment member 536b disposed on the second articulation drive member 514 and configured to align the tube actuator 506 with the second coupler element in the second configuration. The first and second end effector alignment members 536a and 536b may facilitate upward advancement of the tube actuator 406 while maintaining axial alignment with the first or second end effector element 407 or 408, depending on the cage configuration. In some embodiments, the first and second end effector alignment members 536a / b may comprise ring-like or arch-like structures coupled to inner surfaces of the first and second articulation drive members 513 and 514. The first and second end effector alignment members 536 a / b define an opening through which the tube actuator 506 is inserted to access the corresponding coupler element. When the tube actuator 506 is inserted through the first or second end effector alignment members 536 a / b, the inner surface of the first or second end effector alignment members 536 a / b in the first or second configuration, respectively, may contact the outer surface of the tube actuator 506 to restrict lateral movement of the tube actuator 506 and maintain alignment of the tube actuator 506 with the corresponding first or second coupler element. The first and second end effector alignment members 536 a / b may also be configured to be foldable, e.g., to allow the end effector 504 to be closed in a third configuration. In some embodiments, the first end effector alignment member 536a may be configured to move from a folded configuration to an deployed configuration in the first configuration, and the second end effector alignment member 536b may be folded in the first configuration, as shown in Figure 12A. Both the first and second end effector elements 536a / b may be folded in an intermediate cage configuration, as shown in Figure 12B.Also, the second end effector alignment member 536b may be configured to move from a folded configuration to an deployed configuration in the second configuration, as shown in FIG. 12C, and the first end effector alignment member 536b may be folded in the second configuration.

[0086]

[0097] In some embodiments, any of the end effectors described herein may be configured to articulate about the tip of the elongate body or shaft assembly through an angle ranging from at least about 20 degrees (e.g., 20, 40, 60, 80, 90, 100, 110, and 120 degrees, including subranges therebetween), which may enhance visibility of various elements important in performing an anastomosis procedure.

[0087]

[0098] As used herein, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Thus, for example, the term "a member" is intended to mean a single member or a combination of members, and the term "a material" is intended to mean one or more materials or a combination thereof.

[0088]

[0099] As used herein, the terms "about" and "approximately" generally mean plus or minus 10% of the referenced value. For example, about 0.5 includes 0.45 and 0.55, about 10 includes 9-11, and about 1000 includes 900-1100.

[0089]

[0100] As used herein, the term "substantially" and similar terms are intended to have a broad meaning consistent with common and accepted usage by those skilled in the art to which the subject matter of this disclosure pertains. For example, the term "substantially flat" means that a minimal amount of surface irregularities or undulations may exist on an otherwise flat surface due to manufacturing variations. These terms should be understood as intended to enable those skilled in the art, upon reviewing this disclosure, to describe the particular features described and claimed without limiting the scope of those features to the precise configurations and / or numerical ranges provided. Accordingly, these terms should be interpreted as indicating that inseparable or unrelated changes or modifications to the subject matter described and claimed are considered to be within the scope of the invention as set forth in the appended claims.

[0090]

[0101] It should be noted that the term "exemplary" as used herein is intended to indicate that various embodiments are possible examples, representations, and / or illustrations of possible embodiments (and such term is not intended to imply that such embodiments are necessarily excellent or superlative examples).

[0091]

[0102] As used herein, terms such as "coupled" mean the joining of two members directly or indirectly to one another. Such joining may be fixed (e.g., permanent) or movable (e.g., detachable or releasable). Such joining may be achieved either when the two members, or the two members and any additional intermediate members, are integrally formed with one another as a single, unified unit, or when the two members, or the two members and any additional intermediate members, are attached to one another.

[0092]

[0103] It is important to note that the construction and arrangement of the various example embodiments are illustrative only. While only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications (e.g., variations in the size, dimensions, structure, shape, and proportions of various elements, parameter values, mounting arrangements, use of materials, color, orientation, etc.) are possible without substantially departing from the novel teachings and advantages of the subject matter described herein. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the various example embodiments without departing from the scope of the invention.

[0093]

[0104] Although many specific embodiment details are described herein, these should not be construed as limitations on any invention or claims, but rather as descriptions of features specific to particular embodiments of a particular invention. Certain features that are described herein in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented separately in multiple embodiments or in any suitable subcombination. Furthermore, although features may be described above as operative in a certain combination, and even initially claimed as such, one or more features of a claimed combination can, in some cases, be removed from the combination, and a claimed combination may be directed to subcombinations or variations of the subcombination.

[0094]

[0105] Thus, specific embodiments of the present invention have been described. Other embodiments are within the scope of the following claims. The actions recited in the claims may, in some cases, be performed in a different order and still achieve desirable results. Also, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequentiality, to achieve desirable results. In certain embodiments, multitasking and parallel processing may be advantageous.

Claims

1. A long, slender body and an end effector coupled to a distal end of the elongated body; The end effector a first end effector element defining a first receiving portion configured to hold a first coupler element of a coupler; a first articulation drive member connecting a proximal end of the first end effector element to the elongate body; a second end effector element defining a second receiving portion configured to hold a second coupler element of the coupler; a second articulation drive member connecting a proximal end of the second end effector element to the elongate body; The end effector is configured to move between: (i) a first configuration in which the first and second articulation drive members position the first and second end effector elements such that a first axial end of a first tube is received in the first coupler element; (ii) a second configuration different from the first configuration in which the first and second articulation drive members position the first and second end effector elements such that a second axial end of the second tube is received in the second coupler element; and (iii) a third configuration in which the first and second articulation drive members position at least a portion of the first end effector element adjacent to a corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element and connecting the first tube to the second tube. Device.

2. In the first configuration, at least a portion of the first end effector is generally perpendicular to the axis of the elongate body; The device of claim 1 , wherein in the second configuration, at least a portion of the second end effector is generally perpendicular to the axis of the elongate body.

3. In the first configuration, an opening of the first coupler element is generally axially aligned with the elongate body; The apparatus of claim 2 , wherein in the second configuration, the opening of the second coupler element is generally axially aligned with the elongate body.

4. The device of claim 1 , further comprising a tube actuator disposed through an internal channel defined by the elongate body and configured to be axially displaced through the internal channel to protrude through the end effector.

5. 5. The apparatus of claim 4, wherein the tube actuator is configured such that in the first configuration, the axial end of the first tube is received within the first coupler element, and in the second configuration, the axial end of the second tube is received within the second coupler element.

6. a first end effector alignment member disposed on the first articulation drive member and configured to align the tube actuator with the first coupler element in the first configuration; a second end effector alignment member disposed on the second articulation drive member and configured to align the tube actuator with the second coupler element in the second configuration; The apparatus of claim 4 further comprising:

7. the first end effector element and the second end effector element each define a channel therethrough at least a portion thereof; 5. The device of claim 4, wherein in the third configuration, the tube actuator is configured to selectively translate along the axis of the internal channel to push the first and second coupler elements, thereby causing the first and second tubes to exit the first and second receiving portions, respectively.

8. the first and second articulation drive members include first alignment features; the first and second end effector elements include second alignment features; The device element of claim 1 , wherein the first and second alignment features are configured to facilitate alignment and mating of the first coupler element and the second coupler element in the third configuration.

9. 10. The device of claim 1, further comprising a distal articulation drive member coupled to tips of the first end effector and the second end effector and configured to articulate the tips of the first and second end effector elements relative to one another.

10. the distal articulation drive member defines an opening in the third configuration that is continuous with the first and second receiving portions; 10. The apparatus of claim 9, wherein the opening is configured to displace the first and second coupler elements through and from the first and second receivers, thereby releasing the coupler from the end effector.

11. 11. The apparatus of claim 10, wherein the distal articulation drive member comprises a tip stop member configured to limit articulation of the first and second end effector elements to an angle of less than 180 degrees about their respective tips.

12. 10. The apparatus of claim 9, wherein the distal articulation drive member, in the third configuration, is further configured to translate the first and second end effector elements toward or away from one another.

13. The device of claim 1 , wherein the proximal ends of the first and second articulation drive members are configured for translational movement relative to the elongate body.

14. 10. The apparatus of claim 1, further comprising a first actuator coupled to the first and second end effector elements, the first actuator configured to articulate the first and second end effector elements apart from one another about their respective tips.

15. a second actuator coupled to the first and second articulation drive members at their first locations; the second actuator coupled to the second articulation drive member configured to be displaced toward the elongate body to move the end effector to the first configuration; The apparatus of claim 14 , wherein the second actuator coupled to the first articulation drive member is configured to be displaced toward the elongate body to move the end effector to the second configuration.

16. a third actuator having a first tip connected to the first and second articulation drive members at second locations different from the first locations of the first and second articulation drive members; The apparatus of claim 15 , wherein the third actuator is configured to be engaged to move the end effector from the first or second configuration to the third configuration.

17. 17. The device of claim 16, wherein at least one of the first actuator, the second actuator, or the third actuator comprises a tether.

18. 10. The apparatus of claim 1, wherein the end effector is also configured to move to an intermediate configuration in which at least a portion of the first end effector element is adjacent to the corresponding portion of the second end effector element but there is a gap therebetween and the first coupler element is not coupled to the second coupler element.

19. a first end effector element defining a first receiving portion configured to hold a first coupler element of a coupler; a first articulation drive member connecting a proximal end of the first end effector element to an elongate body; a second end effector element defining a second receiving portion configured to hold a second coupler element of the coupler, a distal end of the second end effector element coupled to a distal end of the first end effector element such that the first and second effector elements are articulatable about their respective distal ends; a second articulation drive member connecting a proximal end of the second end effector element to the elongate body; The end effector is configured to move between: (i) a first configuration in which the first and second articulation drive members position the first and second end effector elements such that a first axial end of a first tube is received in the first coupler element; (ii) a second configuration different from the first configuration in which the first and second articulation drive members position the first and second end effector elements such that a second axial end of the second tube is received in the second coupler element; and (iii) a third configuration in which the first and second articulation drive members position at least a portion of the first end effector element adjacent to a corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element and coupling the first tube to the second tube. Device.

20. In the first configuration, at least a portion of the first end effector is configured to be disposed generally perpendicular to an axis of the elongate body; 20. The device of claim 19, wherein in the second configuration, at least a portion of the second end effector is configured to be disposed generally perpendicular to the axis of the elongate body.

21. In the first configuration, the first receiving portion of the first coupler element is generally axially aligned with the elongate body; 21. The apparatus of claim 20, wherein in the second configuration, the second receiving portion of the second coupler element is generally axially aligned with the elongate body.

22. the first end effector element and the second end effector element each define a channel through at least a portion thereof; 20. The device of claim 19, wherein the channels are each configured to axially receive a portion of a tube actuator therethrough in the third configuration, thereby releasing the first and second coupler elements, and thus the first and second tubes coupled thereto, respectively, from the end effector.

23. 20. The apparatus of claim 19, further comprising a distal articulation drive member coupled to tips of the first and second end effectors, the distal articulation drive member configured to articulate the tips of the first and second end effector elements about one another.

24. the distal articulation drive member defines an opening in the third configuration that is continuous with the first and second receiving portions; 24. The apparatus of claim 23, wherein the opening is configured to displace the first and second coupler elements through and from the first and second receivers, thereby releasing the coupler from the end effector.

25. 25. The apparatus of claim 24, wherein the distal articulation drive member comprises a tip stop member configured to limit articulation of the first and second end effector elements to an angle of less than 180 degrees about their respective tips.

26. a first end effector alignment member disposed on the first articulation drive member and configured to align the first coupler element and a tube actuator in the first configuration; a second end effector alignment member disposed on the second articulation drive member and configured to align the second coupler element and tube actuator in the second configuration; 20. The apparatus of claim 19 further comprising:

27. the first and second articulation drive members include first alignment features; the first and second end effector elements include second alignment features; 20. The apparatus of claim 19, wherein the first alignment feature is configured to facilitate mating of the first coupler element with the second coupler element in the third configuration.

28. 20. The apparatus of claim 19, wherein the end effector is also configured to move to an intermediate configuration in which at least a portion of the first end effector element is adjacent to the corresponding portion of the second end effector element but there is a gap therebetween and the first coupler element is not coupled to the second coupler element.

29. 1. A method for performing an anastomosis between a first vessel and a second vessel within a patient's body, comprising: inserting a distal end of an elongate body of a device into the body of the patient, wherein an end effector is coupled to the distal end of the elongate body, the end effector comprising a first end effector element coupled to the elongate body via a first articulation drive member and a second end effector element coupled to the elongate body via a second articulation drive member; moving the end effectors to a first configuration in which at least a portion of the first end effector is generally perpendicular to an axis of the elongate body; inserting an axial end of the first tube through a first coupler element coupled to the first end effector element; moving the end effector to a second configuration in which at least a portion of the second end effector element is generally perpendicular to the axis of the elongate body; inserting an axial end of the second tube through a second coupler element coupled to the second end effector element; moving the end effector to a third configuration, thereby moving at least a portion of the first end effector element adjacent to the corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element, and thus coupling the first tube to the second tube; disengaging the first coupler element from the first end effector element and the second coupler element from the second end effector element; A method comprising:

30. placing the first coupler element in a first receiving portion of the first end effector element; placing the second coupler element in a second receiving portion of the second end effector element; 30. The method of claim 29, further comprising:

31. coupling the axial end of the first tube to the first coupler element by inserting the axial end of the first tube through the first coupler element and then inverting the axial end of the first tube; coupling the axial end of the second tube to the second coupler element by inserting the axial end of the second tube through the second coupler element and then inverting the axial end of the second tube; 30. The method of claim 29, further comprising:

32. ligating the first vessel prior to inserting the elongate body into the body of the patient; ligating the second vessel; 30. The method of claim 29, further comprising:

33. 30. The method of claim 29, further comprising, prior to inserting the tip of the elongate body into the body of the patient, moving the end effector to an intermediate configuration in which at least a portion of the first end effector element is adjacent to but has a gap with the corresponding portion of the second end effector element and the first coupler element is not coupled to the second coupler element.

34. 1. A method for anastomosis, comprising: transitioning an end effector of an anastomosis device to a first configuration after the end effector is positioned within the patient's body; receiving an axial end of a first tube through a first coupler element mounted to a first portion of the end effector when the end effector is in the first configuration; transitioning the end effector to a second configuration different from the first configuration; receiving an axial end of a second tube through a second coupler element mounted to a second portion of the end effector when the end effector is in the second configuration; transitioning the end effector to a third configuration in which at least the first portion of the end effector is positioned proximate to the second portion of the end effector, thereby coupling the first coupler element to the second coupler element and thus the first tube to the second tube; releasing the first and second coupler elements from the end effector; A method comprising:

35. transitioning to the first configuration includes orienting the first portion of the end effector generally perpendicular to an elongate body coupled to the end effector; 35. The method of claim 34, wherein transitioning to the second configuration comprises orienting the second portion of the end effector generally perpendicular to the elongate body.

36. after inserting the axial end of the first tube through the first coupler element, actuating a tube actuator to couple the axial end of the first tube to the first coupler element by flipping the axial end of the first tube; after inserting the axial end of the second tube through the first coupler element, actuating the tube actuator to couple the axial end of the second tube to the second coupler element by inverting the axial end of the second tube; 35. The method of claim 34, further comprising:

37. 35. The method of claim 34, further comprising, prior to positioning the end effector on the body of the patient, transitioning the end effector to an intermediate configuration in which at least a portion of the first end effector element is adjacent to but has a gap with the corresponding portion of the second end effector element and the first coupler element is not coupled to the second coupler element.

Images