Laparoscopic anastomosis devices and methods of use thereof

Abstract

An apparatus includes an elongate body and an end effector coupled to a distal end of the elongate body. The end effector includes a first end effector element configured to hold a first coupling element, a second end effector element configured to hold a second coupling element, and a first end effector element and a second end effector element coupling the first end effector element and the second end effector element to the elongate body. The end effector is configured to move between a first configuration in which the first end effector element and the second end effector element are in a first position in which the axial end of the first blood vessel is coupled to the first coupler element, a second position in which the axial end of the second blood vessel is coupled to the second coupler element, and a third configuration in which the axial end of the second blood vessel is coupled to the second coupler element. The first end effector has a first position in which the axial end of the second blood vessel is coupled to the first coupler element, and a second position in which the axial end of the second blood vessel is coupled to the second coupler element, and a third configuration in which the first end effector and the second end effector are proximate the coupler element and anastomose the first blood vessel and the second blood vessel.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 409,115, filed on September 22, 2022, entitled “LAPAROSCOPIC ANASTASMOSIS DEVICE AND METHOD OF USE THEREOF,” the entire contents of which are incorporated herein by reference.

[0003] Government Support Statement

[0004] 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. Technical Field

[0005] Embodiments described herein generally relate to apparatus for laparoscopically performing anastomosis of two tubular structures. Background Art

[0006] Anastomosis is the connection between two luminal structures. Typically, anastomotic connections are established by surgery on blood vessels (such as veins or arteries) or on tubular gastrointestinal structures (such as intestines). Conventional technology allows anastomosis to be completed between two ends (called end-to-end anastomosis), or anastomosis to be completed between the end of a structure and the side of another structure (called end-to-side anastomosis). Globally, thousands of operations requiring these anastomoses are performed every day. Similarly, a variety of surgical specialties rely on establishing reliable, unobstructed anastomoses to successfully treat corresponding patients. The surgical reattachment of veins and arteries (sometimes referred to as anastomosis in this article for simplicity) helps to restore blood circulation, thereby improving the supply of oxygen and other nutrients to downstream tissues, and improving the return of deoxygenated blood from tissues to the circulatory system. Therefore, it is desirable to reliably perform various vascular anastomosis operations with reduced complexity using minimally invasive surgery. Summary of the invention

[0007] 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 by minimally invasive or laparoscopic surgical methods. Embodiments described herein also relate to laparoscopic systems, methods, and devices that are intended to be used in conjunction with engageable rings or other anastomotic couplers used in microvascular anastomosis to facilitate end-to-end or end-to-side engagement of vascular structures (e.g., arteries and / or veins).

[0008] In some embodiments, an apparatus includes: an elongated body; and an end effector coupled to a distal end of the elongated body, the end effector including: a first end effector element defining a first receiving portion, the first receiving portion configured to retain a first coupling element of a coupling; a first articulated member, The invention relates to a method of manufacturing a first end effector element and a second end effector element for coupling a proximal end of the first end effector element to the elongated body; a second end effector element defining a second receiving portion configured to retain a second connector element of the connector; a second hinge member coupling a proximal end of the second end effector element to the elongated body; wherein the end effector is configured to move between: (i) a first configuration in which the first and second hinge members configure the first and second end effector elements to allow a first axial end of a first blood vessel to be received in the first connector element; (ii) a second configuration different from the first configuration in which the first and second hinge members configure the first and second end effectors to allow a second axial end of a second blood vessel to be received in the second connector element; and (iii) a third configuration in which the first and second hinge members configure at least a portion of the first end effector element to be adjacent to a corresponding portion of the second end effector element such that the first connector element is coupled to the second connector element to couple the first blood vessel to the second blood vessel.

[0009] In some embodiments, an apparatus includes: a first end effector element defining a first receiving portion, the first receiving portion configured to retain a first coupler element of a coupler; a first articulation member coupling a proximal end of the first end effector element to an elongated body; a second end effector element defining a second receiving portion, the second receiving portion configured to retain a second coupler element of the coupler, a distal end of the second end effector element coupled to the distal end of the first end effector element so that the first end effector element and the second end effector element are capable of articulated movement about their respective distal ends; and a second articulation member coupling the proximal end of the second end effector element to the elongated body; wherein the end effector is configured to move between the following configurations: (i) a first configuration, wherein the first and second articulated members configure the first and second end effector elements to allow the first axial end of the first blood vessel to be received in the first connector element; (ii) a second configuration different from the first configuration, wherein the first and second articulated members configure the first and second end effector elements to allow the second axial end of the second blood vessel to be received in the second connector element; and (iii) a third configuration, wherein the first and second articulated members configure at least a portion of the first end effector element to be adjacent to a corresponding portion of the second end effector element such that the first connector element is coupled to the second connector element to couple the first blood vessel to the second blood vessel.

[0010] In some embodiments, a method for anastomosing a first blood vessel to a second blood vessel in a patient comprises: inserting a distal end of an elongated body of a device into the patient, an end effector coupled to the distal end of the elongated body, the end effector comprising a first end effector element coupled to the elongated body by a first hinge member and a second end effector element coupled to the elongated body by a second hinge member. Disposing the second coupler element of the coupler in a second receiving portion of the second end effector element. Inserting the distal end of the elongated body into the patient. Moving the end effector to a first configuration in which at least a portion of the first end effector is substantially perpendicular to an axis of the elongated body. Inserting an axial end of the first blood vessel through the first coupler element. Moving the end effector to a second configuration in which at least a portion of the second end effector element is substantially perpendicular to an axis of the elongated body. Inserting an axial end of the second blood vessel through the second coupler element. Moving the end effector to a third configuration so that at least a portion of the first end effector element is moved proximate 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 blood vessel to the second blood vessel. The first coupler element is released from the first end effector element, and the second coupler element is released from the second end effector element.

[0011] In some embodiments, a method for anastomosis comprises: after an end effector of an anastomotic device has been positioned within a patient's body, converting the end effector to a first configuration; when the end effector is in the first configuration, receiving an axial end of a first blood vessel by a first connector element mounted to a first portion of the end effector; converting the end effector to a second configuration different from the first configuration; when the end effector is in the second configuration, receiving an axial end of a second blood vessel by a second connector element mounted to a second portion of the end effector; converting the end effector to a third configuration, in which at least a first portion of the end effector is positioned proximate to a second portion of the end effector to couple the first connector element to the second connector element, thereby coupling the first blood vessel to the second blood vessel; and releasing the first connector element and the second connector element from the end effector.

[0012] It should be understood that all combinations of the aforementioned concepts and the additional concepts discussed in more detail below (assuming that these concepts are not mutually contradictory) are considered to be part of the inventive subject matter disclosed herein. In particular, all combinations of the claimed subject matter appearing at the end of this disclosure are considered to be part of the inventive subject matter disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The foregoing and other features of the present disclosure will become more apparent from the following description and the appended claims in conjunction with the accompanying drawings. It should be understood that these drawings depict only several embodiments according to the present disclosure and are therefore not to be considered as limiting the scope of the present disclosure, which will be described with greater clarity and detail through the use of the accompanying drawings.

[0014] Figure 1A is a schematic diagram of an apparatus for performing laparoscopic anastomosis of two blood vessels according to an embodiment, Figure 1B yes Figure 1A Schematic diagram of the distal portion of the device, showing the Figure 1A The device couples the first blood vessel and the second blood vessel to each other.

[0015] Figure 2 is a schematic diagram of a laparoscopic device for coupling a first blood vessel to a second blood vessel relative to a patient's body using a stapling device according to an embodiment.

[0016] Figure 3A-3H is a schematic diagram of various steps of a method for coupling a first blood vessel to a second blood vessel using an anastomotic device according to an embodiment.

[0017] Figure 4A-4F are various perspective views of an anastomotic device according to an embodiment, illustrating various steps for coupling a first blood vessel to a second blood vessel.

[0018] Figure 5A and Figure 5B is a flow chart of a method for laparoscopically coupling a first blood vessel to a second blood vessel according to an embodiment.

[0019] Figure 6 is a perspective view of a portion of an apparatus for performing a laparoscopic anastomosis of two blood vessels according to an embodiment.

[0020] Fig. 7A and FIG. 76B shows a method for converting Figure 6 The end effector element of the device moves to a partially open position ( Fig. 7A ) and fully open position ( Figure 7B )'s first actuator.

[0021] Fig. 8A Shows Figure 6 a perspective view of a portion of an apparatus showing a second actuator configured to move an end effector of the apparatus between various angular orientations according to an embodiment; Figure 8B Shown in a first angle orientation Figure 6 The end effector.

[0022] Fig. 9A Shows Figure 6a side view of a portion of an apparatus showing a third actuator configured to move an end effector of the apparatus from an open configuration to a closed configuration according to an embodiment; Figure 9B-9D Shown in a closed configuration assisted by a third actuator Figure 6 The end effector of the device.

[0023] Figure 10A-10C The first configuration ( Fig. 10A ), the second configuration ( Fig. 10C ) and the angular orientation between the first configuration and the second configuration ( Fig. 10B )of Figure 6 Side view of the end effector of the device.

[0024] Fig.11 The first actuator, the second actuator and the third actuator are assisted by the first actuator, the second actuator and the third actuator. Figure 6 The end effector of the device.

[0025] Figure 12A-12C A side view of an end effector including alignment features and alignment members is shown according to an embodiment.

[0026] Reference is made to the accompanying drawings in the following detailed description. In the drawings, like reference numerals generally refer to like parts unless the context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be employed, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It is readily understood that the various aspects of the disclosure as generally described herein and illustrated in the drawings may be arranged, substituted, combined, and designed in a variety of different configurations, all of which are expressly contemplated and constitute a part of the present disclosure. DETAILED DESCRIPTION

[0027] 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 by minimally invasive or laparoscopic surgical methods. Embodiments described herein also relate to laparoscopic systems, methods, and devices that are intended to be used in conjunction with engageable rings or other anastomotic couplers used in microvascular anastomosis to facilitate end-to-end engagement of vascular structures (e.g., arteries and / or veins).

[0028] Anastomosis is the connection between two luminal structures. Typically, anastomotic connections are established surgically on blood vessels (such as veins or arteries) or on tubular gastrointestinal structures (such as intestines). Conventional techniques allow the anastomosis to be completed between two ends (called end-to-end anastomosis), or between the end of one structure and the side of another structure (called end-to-side anastomosis). Globally, thousands of operations requiring these anastomoses are performed every day. Similarly, a variety of surgical specialties rely on establishing reliable, unobstructed anastomoses to successfully treat the corresponding patients. Surgical reattachment of veins can help restore blood circulation, thereby improving the supply of oxygen and other nutrients to downstream tissues, and improving the return of deoxygenated blood from tissues to the circulatory system. It is hoped that various vascular anastomosis operations can be reliably performed with reduced complexity using minimally invasive surgery.

[0029] The original technique used to perform the anastomosis was created by Alexis Carrel, who later won the 1912 Nobel Prize for his pioneering work. Despite the 110 years of evolution and innovation in surgery since the development of microsurgical anastomosis, most vascular anastomoses to this day still utilize suture techniques similar to those originally described by Carrel in the early 20th century. In the 1970s, gastrointestinal anastomotic devices were introduced, which quickly replaced the primary suture technique for intestinal anastomosis. However, most surgeons still use circular suture techniques in the serosal layer overlying the anastomotic site after the anastomosis to increase support. Although generally successful, these techniques can take a long time, often require additional surgical expertise, and can result in leaks (blood, fecal contents, gastric contents, lymphatic fluid, etc.), constrictions, stenosis, and / or obstruction at the anastomotic site if performed incorrectly. In the case of vascular anastomoses, stenosis and / or obstruction can lead to catastrophic complications such as heart attack, stroke, peripheral limb ischemia, amputation, death, reconstruction failure, and soft tissue loss.

[0030] With the understanding of the importance of reliable, open anastomosis, microvascular anastomosis couplings can provide a superior alternative to sutures and staples. Microvascular anastomosis couplings can be composed of two coupling rings, each of which has a tissue engaging surface including a plurality of spikes. A blood vessel is passed through the center of each ring, and the vessel wall is everted or turned inside out and fixed with tissue spikes. This is done at each end of the vessel, and then the two rings are brought together, and the spikes / pins are forced into the opposing rings to join the ends together.

[0031] Microvascular anastomosis of blood vessels can be accomplished using microanastomotic coupling devices, such as the GEM™ FLOW COUPLER device. However, current anastomotic couplings are not designed or easily adapted for minimally invasive procedures, such as laparoscopic surgery or microsurgery, due to poor visibility, limited operating space, and a lack of devices for applying two anastomotic couplings together that can be introduced through a small diameter trocar port.

[0032] Manual suturing is primarily used for surgical anastomosis of blood vessels in minimally invasive surgery due to the lack of reliable devices or techniques to apply anastomotic couplers laparoscopically. Manual suturing of blood vessels is quite challenging, primarily due to the small size of the vessels and the extremely small working space. Since most blood vessels are only 1-8 mm in diameter, the procedure typically involves the use of a surgical microscope. The thickness of the suture is approximately 70 μm, which is difficult to handle. Therefore, surgeons and surgical residents must undergo extensive additional training before operating on patients requiring tissue transplants. In addition, surgeons attempt to limit recipient site morbidity, resulting in small incisions and small working areas. For example, in breast reconstruction after microsurgical mastectomy, surgeons will typically work within a surgical field of 2.5 cm to 3 cm. These size constraints make it difficult for surgeons to manipulate surgical instruments. Arterial anastomosis performed by manual suturing in the operating room takes approximately 23.5 minutes, which is not ideal.

[0033] In contrast, embodiments of the anastomosis devices and methods of use described herein may provide one or more benefits, including, for example: 1) allowing minimally invasive laparoscopic surgery to perform anastomosis of two tubular tissues (e.g., blood vessels, nerves, etc.) through a small incision with a diameter of less than about 25 mm; 2) achieving anastomosis by simply clamping a connector element by an end effector, the end effector comprising a pair of end effector elements, the end effector elements being configured to open or close to couple the connector elements together, allowing anastomosis of two blood vessels in less than about 5 minutes; 4) enabling articulated movement of the end effector about a longitudinal axis to provide surgical flexibility and allow the end effector to access difficult-to-reach areas; 5) providing an elongated body coupled to the end effector, the elongated body being greater than about 8 inches in length, allowing insertion through an incision in the abdominal wall or other part of the user's body while still allowing anastomosis of blood vessels in the patient's pelvic floor; 6) providing a multifunctional interface, allowing all operations to be performed from the interface 7) provide 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) provide significant clinical applicability, utility and novelty in a variety of surgical procedures used to treat a variety of pathophysiological 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.

[0034] In some embodiments, any of the systems, methods, and devices described herein may be used to treat indications including BPH. In some embodiments, any of the systems, methods, and devices described herein may be used to treat indications including prostate cancer. In some embodiments, any of the systems, methods, and devices described herein may be used to treat indications including male infertility. In some embodiments, any of the systems, methods, and devices described herein may be used to treat indications including androgen deprivation therapy. In some embodiments, any of the systems, methods, and devices described herein may be used to treat indications including uterine fibroids. In some embodiments, any of the systems, methods, and devices described herein may be used to treat indications including endometriosis. In some embodiments, any of the systems, methods, and devices described herein may be used to treat indications including polycystic ovary syndrome.

[0035] Various embodiments of systems, methods, and devices are disclosed herein that make anastomosis easier and more time-saving by using an anastomotic coupling in microsurgery and laparoscopy. Simplifying the anastomosis procedure minimizes the skill required by the operator, reduces the duration of high concentration, and helps reduce surgeon fatigue during long, complex procedures.

[0036] The present disclosure and the accompanying drawings are intended to describe some but not necessarily all examples or embodiments, and do not limit the scope of the present disclosure in any way. Any drawings referenced herein may not be drawn to scale and may be enlarged in proportion for ease of explanation. In the following explanation of several different examples of embodiments, corresponding features are represented by the same reference numerals.

[0037] For clarity of disclosure, the terms "near" and "far" are defined herein relative to a human or robotic operator of a surgical instrument. The term "near" refers to an element position that is closer to a human or robotic operator of a surgical instrument and further away from a surgical end effector of the surgical instrument. The term "far" refers to an element position that is closer to a surgical end effector of a surgical instrument and further away from a human or robotic operator of the surgical instrument. In addition, the terms "upper", "lower", "side", "lateral", "bottom", and "top" are relative terms to provide additional clarity for the description of the figures provided below. Therefore, the terms "upper", "lower", "side", "lateral", "bottom", and "top" are not intended to unnecessarily limit the invention described herein.

[0038] In general, the present disclosure relates to several systems, methods, and devices for applying anastomotic couplings for minimally invasive vascular surgery, particularly for performing anastomoses between hollow tissue structures when access to a tissue site is limited. In some embodiments, a device (sometimes referred to herein for simplicity as an anastomotic device, apparatus, or surgical instrument) is configured for applying an anastomotic coupling via a laparoscopic approach and includes a proximal handle portion or interface, an intermediate shaft assembly of a body extending distally from the handle portion, and an end effector disposed at a distal end of the shaft assembly.

[0039] For example, according to one embodiment, Figure 1A is a schematic diagram of a stapling device 100 for performing a laparoscopic anastomosis of a first blood vessel V1 to a second blood vessel V2, Figure 1B yes Figure 1A A schematic diagram of a portion of the device 100 is shown by Figure 1AThe device 100 couples a first blood vessel V1 and a second blood vessel V2 to each other. The device 100 includes: a body 102 coupled to an interface 104, which may include one or more actuators 106 contained in the interface or otherwise coupled to the interface; an end effector 120, which includes: a first end effector element 122a configured to removably receive a first coupling element 130a of a coupling 130; and a second end effector element 122b configured to removably receive a second coupling element 130b of a coupling 130. The device 100 may also optionally include an actuation mechanism 140, a fixing mechanism 105, and / or a release mechanism 107.

[0040] The body 102 may include an elongated member that may have a length in the range of 4 inches to 30 inches, including all subranges and values ​​therebetween (e.g., 4, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 25, 28, or 30 inches, inclusive). In some embodiments, the body 102 may have a length of at least 8 inches. The body 102 may be formed of any suitable material, such as stainless steel, alloys, etc. The body 102 may define a longitudinal passage therethrough, through which various components of the device 100 may be configured. In some embodiments, the sheath 10 may be configured around the body 102. The sheath 10 may be formed of any suitable material, such as stainless steel, alloys, plastics, etc. A user may selectively move the body 102 axially within the sheath 102, for example, to at least partially extend or retract an end effector relative to the sheath 10.

[0041] The proximal end of the body 102 is coupled to the interface 104 such that the elongated body extends longitudinally from the interface. The interface 104 may include a housing that may have an ergonomic shape for a user to grasp. For example, in some embodiments, the interface 104 may be shaped as a handle, or may include a finger or hand grip to facilitate a user to grasp the interface 104 and manipulate the interface 104 to perform a laparoscopic anastomosis of two blood vessels or any other tubular structure.

[0042] One or more actuators 106 can be coupled to the interface 104. In some embodiments, the actuator 106 can include a button, a lever, a trigger configured to be engaged by an index and / or middle finger of a user, a thumb trigger configured to be engaged or otherwise manipulated by a thumb of a user, a slide actuator, a clip, a lever, a knob, a scissor lever, or other first class, any other suitable actuator, and / or combinations thereof. In some embodiments, the device 100 can also include an actuation mechanism 140 that extends through one or more channels defined through the body 102 and operatively couples the actuator 106 to the end effector 120, for example, to cause a corresponding action or movement of the end effector 120. Such an actuation mechanism 140 can include, for example, a rod, a gear, a rack and pinion, a piston, a lever, a belt, a wire, a rope, a pulley, and the like.

[0043] For example, one or more actuators 106 can be configured to articulate the first end effector element 122a and the second end effector element 122b around the distal end of the body 102 in one or more directions to separate from each other and / or approach each other. For example, 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, 122b are separated from each other and a second configuration in which the two end effector elements 122a, 122b are adjacent to each other. In the second configuration, the two end effector elements 122a, 122b can be configured to couple the first coupling element 130a to the second coupling element 130b. In some embodiments, the first end effector element and the second end effector element 122a, 122b can also be configured to be in an intermediate configuration, for example, between the first configuration and the second configuration. One or more actuators 106 may be coupled to an actuation mechanism 107, which may be driven by the one or more actuators 106 to cause movement of the first and second end effector elements 122a, 122b. In some embodiments, the actuator 106 may be configured to cause one or more portions of the end effector 120 (e.g., the first end effector element 122a and / or the second end effector element 122b) to articulate in a single direction (e.g., a first direction), while in other embodiments, the actuator 106 may be configured to cause one or more portions of the end effector 120 to articulate in multiple directions (e.g., a first direction and a second direction). For example, the first direction may include rotation of the distal ends of the first and second end effector elements 122a / b to move toward or away from each other around the distal end of the body 102, such as Figure 1BAdditionally or alternatively, the second direction may include articulating movement of the first end effector and the second end effector 122a / b together in a direction substantially orthogonal to the first direction, such as Figure 1B , thereby allowing flexibility in positioning the end effector 120 at a desired location within the patient P. In some embodiments, the first actuator 106 may be configured to rotate the first end effector element 122a about a first axis, for example, to move the first end effector element 122a toward or away from the second end effector element 122b. In some embodiments, the second actuator 106 may be configured to rotate the second end effector element 122b about a second axis, for example, to move the second end effector element 122b toward or 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 may be the same axis, while in other embodiments, the two axes may be offset from each other. In some embodiments, the first and second end effector elements 122a, 122b can also be pivoted about a third axis or angled away from the longitudinal axis of the body, for example, to position the first and second end effector elements 122a, 122b for easier viewing by a user (e.g., a surgeon).

[0044] For example, in some embodiments, movement in a first direction may include articulated movement of the first end effector element and / or the second end effector element 122a / b in a plane extending along the longitudinal axis of the end effector 120, and the second direction may include articulated movement of the first end effector element and the second end effector element 122a / b around a plane extending along the longitudinal axis.

[0045] like Figure 1A-1BAs shown, the end effector 120 is coupled to the distal end of the elongated body 102. The end effector 120 includes a first end effector element 122a and a second end effector element 122b, the first end effector element defining a first receiving portion of the first coupling element 130a configured to hold the coupling 130, and the second end effector element defining a second receiving portion of the second coupling element 130b configured to hold the coupling 130. The coupling 130 may include any suitable coupling that can be used to connect two blood vessels or any other tubular tissue structure. For example, the first coupling element 130a may include an annular member that defines a central opening that is configured to receive the axial end of the first blood vessel V1. Similarly, the second coupling element 130b may also include an annular member that is configured to receive the axial end of the second blood vessel V2. In some embodiments, the second coupling element 130b may be a mirror image of the first coupling element 130a.

[0046] In some embodiments, each of the first and second coupling elements 130a / b can include coupling features, such as matching snap-fit ​​features (e.g., pins, grooves, slits, flanges, protrusions, notches, depressions, detents, etc.), such that the first coupling element 130a is coupled to the second coupling element 130b when the respective surfaces of the first and second coupling elements 130a / b are pressed against each other. This also causes the respective axial ends of the first and second blood vessels V1 and V2 to contact each other, which can cause the blood vessels V1 and V2 to couple to each other. In some embodiments, the axial ends of the first and second blood vessels V1 and V2 can be flared outward before coupling them together.

[0047] In some embodiments, the first and second end effector elements 122a, 122b may be implemented as clamps or clamp arms that are articulated about their proximal ends such that the proximal ends of the first and second end effector elements 122a / b remain proximal to each other during operation, while the distal ends of the first and second end effector elements 122a / b are selectively movable away from each other to open or 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 of the first end effector element 122a (e.g., its distal end) is separated from a corresponding portion of the second end effector element 122b (e.g., its corresponding distal end) such that the first coupling element 130a is separated from the second coupling element 130b, and a second configuration in which at least a portion of the first end effector element 122a is proximal to a corresponding portion of the second end effector element 122b such that the first coupling element 130a is coupled to the second coupling element 130b (e.g., such as Figure 1B) in order to connect the first blood vessel V1 to the second blood vessel V2.

[0048] In some embodiments, in a first configuration, the first and second end effector elements 122a / b may be separated laterally by a fixed or variable distance along their lengths. The first and / or second end effector elements 122a, 122b may then be displaced laterally toward each other until the first and second coupler elements 130a / b are coupled together in a second configuration. The lateral displacement may be a lateral translation.

[0049] In some embodiments, the proximal ends of the first and second end effector elements 122a, 122b may be coupled to the distal end of the elongated body 102. The first and second coupling elements 130a, 130b may be removably coupled to the respective distal ends of the first and second end effector elements 122a, 122b, respectively. In addition, the first and second end effector elements 122a / b may be configured to articulate along a first direction around the distal end of the elongated body 102 (e.g., as indicated by arrow A) to move the end effector 120 between the first configuration and the second configuration. In some embodiments, the proximal ends of the first and second end effector elements 122a / b may be coupled to the distal end of the elongated body 102 via an actuation mechanism 140, which may be configured to allow the first and second end effector elements 122a / b to articulate, as previously described.

[0050] In some embodiments, the end effector 120 may further include an intermediate member that couples the first and second end effector elements 122a / b to the elongated body 102. For example, Figure 1A-1BAs shown, the end effector 120 may include a first intermediate member 123a coupling the first end effector element 122a to the elongated body 102 and a second intermediate member 123b coupling the second end effector element 122b to the elongated body 102. In some embodiments, the first and second intermediate members 123a / b may be configured to articulate about their proximal ends (i.e., about the elongated body 102), and the first and second end effector elements 122a / b may be configured to articulate about their respective proximal ends about the distal ends of the first and second intermediate members 123a / b. Thus, the first and second intermediate members 123a / b enable the first and second end effector elements 122a / b to have multiple degrees of freedom, which may facilitate the operation of the end effector 120. In some embodiments, the distal ends of the first and second end effector elements 122a / b may be coupled to each other and may be configured to articulate about their respective distal ends. In such an embodiment, the end effector 120 can be opened and closed in a cage-like manner to perform vascular anastomosis. Figure 2 A- Fig.11 C describes such embodiments in more detail.

[0051] In some embodiments, the actuation mechanism 140 may also be configured to move the first and second end effector elements 122a / b to an intermediate configuration in which at least a portion (e.g., a distal end thereof) of the first end effector element 122a is adjacent to a corresponding portion of the second end effector element 122b, but with a gap therebetween, such that the first coupling element 130a is not coupled to the second coupling element 130b. This may advantageously reduce the lateral width of the end effector 120 to facilitate insertion into the body of the patient P through a small incision (e.g., less than 25 mm in diameter), thereby reducing trauma and allowing for faster healing.

[0052] Any suitable drive 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. Each of the first linkage arm and the second linkage arm may include a central hinge, such that movement of the proximal end of each of the first linkage arm and the second linkage arm proximate to the respective distal ends of the first linkage arm and the second linkage arm will cause the first linkage arm and the second linkage arm to articulate away from each other about their respective central hinges, thereby selectively moving the end effector from the first configuration to the second configuration. In other words, the first linkage arm and the second linkage arm may function as scissor arms to move the first and second end effector elements 122a / b between the first configuration and the second configuration.

[0053] In some embodiments, the actuation mechanism 140 may include at least one pulley coupled to a respective one of the first end effector element 122a and / or the 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 displaced longitudinally (e.g., by a user engaging a respective actuator 106). Since the tether runs around the pulley, displacing the tether will cause the at least one pulley to rotate and move the end effector between the first configuration and the second configuration.

[0054] In some embodiments, the actuation mechanism 140 may include at least one rod coupled to a corresponding one of the first end effector element 122a or the second end effector element 122b and configured to rotate to move the end effector 120 between the first configuration and the second configuration. For example, the at least one rod may be coupled to a corresponding one of the first end effector element 122a and / or the second end effector element 122b near a radially outer edge of the corresponding one of the first end effector element 122a or the second end effector element 122b. Thus, rotating the rod will cause the radially outer edges of the first end effector element and the second end effector element 122a / b located distal to the axial end of the rod to move closer to or farther from each other, thereby moving the end effector 120 between the first configuration and the second configuration.

[0055] In some embodiments, the end effector 120 may be at least partially retracted into an optional sheath 10, or the sheath 10 may be axially displaced relative to the end effector 120 such that an inner surface of the distal end of the sheath 10 covers or surrounds an outer surface of each of the first and second end effector elements 122a / b. In some embodiments, the diameter of the sheath 10 may be less than or approximately equal to the maximum lateral width of the end effector 120, such that axial displacement of the sheath 10 toward the end effector 120 (or retraction of the end effector 120 into the sheath 10) causes the first and second end effector elements 122a / b to change to the second configuration.

[0056] In some embodiments, at least one closing element may be coupled to the first end effector element 122a and the second end effector element 122b and configured to cause the end effector to change to the second configuration. The closing element may include, for example, a mechanical linkage, a rope, a line, a suture, a filament, an extrusion, a spring, a rubber band, an elastic cord, any other suitable closing element, or any combination thereof. The closing 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, an elastic element may be additionally or alternatively coupled to the first end effector element 122a and / or the second end effector element 122b and configured to bias the end effector 120 toward the open configuration. The resilient element may include, for example, a biasing member such as a spring, an elastic plate (e.g., a NITNOL plate), a mechanical linkage, a rope, a wire, a suture, a filament, an extrusion, etc., and is configured to bias the first end effector element and / or the second end effector element 122a / b toward the first configuration.

[0057] In some embodiments, each of the first and second end effector elements 122a, 122b can be configured to be torsionally bent along their respective axes to move between a first configuration and a second configuration. For example, each of the first and second end effector elements 122a / b can include an actuating stem that can be in the shape of a continuum structure through which spiral tendon filaments are threaded. Such a structure can include a set of discs through which push-pull tendon filaments are threaded to follow a spiral shape around the main axis of the structure. In other embodiments, the stem can be mesh-like. The actuation mechanism 140 can be configured to engage the tendon filaments so that the shaft of each of the first and second end effector elements 122a / b undergoes not only pure rotation but also twisting along the main axis of the shaft, thereby causing at least the distal ends of the first and second end effector elements 122a / b to move away from each other to move the end effector 120 to the first configuration, or causing the first and second end effector elements 122a / b to move toward each other to move the end effector 120 to the second configuration. This composite motion not only separates the distal ends of the first and second end effector elements 122a / b by bending the first and second end effector elements 122a / b away from each other, but also exposes the inner surface and ultimately the first and second coupler elements 130a / b coupled thereto by rotating the first and second end effectors about their respective longitudinal axes.

[0058] In some embodiments, each of the first end effector element 122a and the second end effector element 122b may include an alignment feature defined on their respective surfaces. The alignment features may be configured to align the first and second end effector elements 122a / b when the end effector 120 is moved to the second configuration, for example, to facilitate alignment of the first coupling element 130a with the second coupling element 130b. Such alignment features may include, but are not limited to, one or more notches, lips, grooves, recesses, detents, protrusions, or other mating features to facilitate coarse and fine alignment of the first coupling element 130a with the second coupling element 130b during actuation of the device 100 to move the end effector 120 from the first configuration to the second configuration. In addition, the end effector 120 may include one or more grips, grooves, surface modifications, latching mechanisms, or any combination thereof to facilitate controlled anastomosis.

[0059] Optionally, in some embodiments, the device 100 may include a fixing mechanism 105, which may be configured to selectively fix 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, for example, for releasing the first coupler element 130a and / or the second coupler element 130b from the end effector 120. In some embodiments, the receiving portions of the first end effector element and the second end effector element 122a / b may include cutouts, cavities, slits, etc., which are shaped and sized to tightly receive the first coupler element and the second coupler element 130a / b, respectively (e.g., by friction fit). In some embodiments, the first and second coupler elements 130a / b can be selectively fixed in their respective receiving portions or released from the receiving portions, for example, by means of the fixing mechanism 105 and / or the release mechanism 107. For example, in the second configuration, the release mechanism 107 can be configured to be selectively actuated to release the coupler 130 from the end effector 120. In some embodiments, the release mechanism 107 can be coupled to the fixation mechanism 105, for example, such that movement of the fixation mechanism 105 can drive movement of the release mechanism 107 to release the coupler 130. Alternatively, the device 100 may not include the fixation mechanism 105 or the release mechanism 107. In this case, the surgeon can use a separate tool (e.g., forceps, hooks, etc.) to disengage the coupler elements 130a / b from the end effector elements 122a / 122b.

[0060] Any suitable securing mechanism 105 may be used. In some embodiments, at least one of the first coupling element 130a and the second coupling element 130b may define a circumferential groove on its radially outer surface, for example, in a radial edge thereof circumferentially surrounding the first coupling element and / or the second coupling element 130a / b. In such embodiments, the securing mechanism 105 may include a thread (e.g., a rope, cord, line, belt, chain, etc.) disposed in a portion of the circumferential groove to secure the first coupling element 130a or the second coupling element 130b.

[0061] Figure 2 A schematic diagram of the laparoscopic stapling device is shown, followed by Figure 3A-3H According to various embodiments, Figure 2 Schematic diagram of the end effector of the device shown coupling a first blood vessel to a second blood vessel.

[0062] Figure 2 A laparoscopic stapling device 200 according to an embodiment is shown. The proximal end 201 of the device 200 includes an actuator 202 interface, for example, for actuation by a user. The device body 203 serves as a connection point between the proximal and distal ends of the device 200 and embodies the form factor of a minimally invasive device. The end effector 204 of the device 200 allows various operations to be performed with an appropriate range of motion based on the connection to the proximal end (including the interface 201 and the actuator 202) via the body 203.

[0063] In each step of using the embodiment, Figure 3A An exemplary end effector 304 is shown. In this embodiment, the distal end of the device, the body 205, and the end effector 304 may include internal channels 209, 210 for navigating a vessel actuator 206 that can translate along the axis of the internal channels 209, 210. The vessel actuator 206 can be used to grasp the end of a vessel and connect the vessel to anastomotic coupling rings 211, 212 that may be present in the respective clamps 207, 208. The end effector 204 may include clamps 207, 208 and articulation members 213, 214 for the respective clamps 207, 208. The distal end of the device may include two clamps 207, 208 that may be connected at the distal end of the device by a distal articulation member 215. The distal articulation member 215 may allow for a wide range of mobility required to achieve three device positions or configurations, for example, for successful anastomosis.

[0064] In further detail, the body 205 (also referred to herein as the "elongated body 205") comprises an elongated structure extending longitudinally from the interface 201. The elongated body 205 can define an internal passage 209 along its longitudinal axis. The vascular actuator 206 can be configured to displace or translate axially through the internal passage 209, for example, by selectively protruding through the end effector 204 by being displaced distally relative to the elongated body 205, as described herein. Although not shown, in some embodiments, an outer sheath can be disposed around the elongated body 205.

[0065] The end effector 204 is coupled to the distal end of the elongated body 205 and includes a first end effector element 207 (also referred to herein as the "first clamp 207"), a second end effector element 208 (also referred to herein as the "second clamp 208"), a first articulation member 213, a second articulation member 214, and in some embodiments, a distal articulation member 215 (collectively referred to herein as the "device joints 214, 213, 215"). The first end effector element 207 defines a first receiving portion, cavity or opening configured to retain a coupling ring 211 (also referred to herein as the "first coupling element 211"), and the second end effector element 208 defines a second receiving portion, cavity or opening configured to retain a coupling ring 212 (also referred to herein as the "second coupling element 212"). The first and second coupling elements 211, 212 form two parts that form a coupler when they are coupled together. The distal end of the second end effector element 207 can be coupled to the distal end of the first end effector element 208 so that the first and second end effector elements 207, 208 can be articulated about their respective distal ends. For example, in some embodiments, the distal articulation member 215 can couple the distal end of the first end effector element 207 to the distal end of the second end effector element 208 to allow the distal ends of the first and second end effector elements 207, 208 to articulate about each other. In some embodiments, the distal articulation member 215 can be configured to enable articulation and translation of the first and second end effector elements 207, 208. For example, the distal articulation member 215 can include a longitudinal slit in which a pin is disposed to couple the first end effector element 207 to the second end effector element 208. The pin may allow the clamping elements of the first and second end effector elements 207, 208 to rotate about each other to move from an open configuration to a closed configuration. In addition, for example, in the closed configuration of the end effector 204, the pin may be configured to slide in the longitudinal slit to allow the first and second end effector elements 207, 208 to slide toward (or away from) each other. This may help align the connector elements 211, 212 disposed in the respective first and second end effector elements 207, 208 with each other, and allow the first and second end effector elements 207, 208 to allow the connector elements 211, 212 to move toward each other to facilitate the connection of the connector elements 211, 212 and anastomose the axial ends of the two blood vessels V1 and V2, as described previously herein.

[0066] The first hinge member 213 couples the proximal end of the first end effector 207 to the elongated body 205, and the second hinge member 214 couples the proximal end of the second end effector element 208 to the elongated body 205. For example, the proximal ends of the first and second hinge members 213, 214 may be coupled to an outer end surface or portion of the elongated body 205 and configured to articulate about their respective distal ends. The distal ends of the first and second hinge members 213, 214 may be coupled to the proximal ends of the first and second end effector elements 207, 208, respectively, so that the first and second end effector elements 207, 208 may articulate about the respective distal ends of the first and second hinge members 213, 214, respectively. In this way, the combination of the first and second hinge members 213, 214 that can be articulated around the proximal ends, the first and second end effector elements 207, 208 that can be articulated around the respective proximal ends at the respective distal ends of the first and second hinge members 213, 214, and the distal hinge member 215 forms a cage-like structure with multiple degrees of freedom. This can allow the cage-like structure to be opened, closed, and / or moved to different angular positions to facilitate the insertion of the axial ends of the blood vessels V1 and V2 into the first and second connector elements 211, 212 and the coupling of the first and second connector elements 211, 212 for anastomosis of the distal ends of the blood vessels V1, V2.

[0067] In some embodiments, the first and second articulated members 213, 214 may be coupled to the elongated body 205 via a coupling element or linkage configured to allow the first and second articulated members 213, 214 to slide or translate, the first and second articulated members coupling the end effector 204 to the elongated body 205 along a side of the elongated body 205. This may allow the first and second articulated members 213, 214, and thereby the first and second end effector elements 207, 208, to translate proximally or distally, thereby facilitating translation and rotation of the end effector 204 in various directions. In various embodiments, the coupling element or linkage may include a slit defined in a side wall of the elongated body 205 and a sliding linkage coupled to the slit or to a coupler within the slit, thereby allowing for an increased range of motion.

[0068] The end effector 204 may be configured to move between various position configurations. For example, in some embodiments, the end effector 204 is configured to move between: (i) a first configuration, wherein the first and second articulated members 213, 214 set the first end effector element 207 in a first position separated from the second end effector element 208 to allow the first axial end of the first blood vessel V1 to be received in the first connector element 211; (ii) a second configuration, wherein the first and second articulated members 213, 214 set the first end effector element 207 in a second position different from the first position separated from the second end effector element 208 to allow the second axial end of the second blood vessel V2 to be received in the second connector element 212; and (iii) a third configuration, wherein the first and second articulated members 213 set at least a portion of the first end effector element 207 proximate to a corresponding portion of the second end effector element 208, so that the first connector element 211 is connected to the second connector element 212 to connect the first blood vessel V1 to the second blood vessel V2. In some embodiments, the end effector 204 is further configured to move to an intermediate configuration in which at least a portion of the first end effector element 211 is proximate to a corresponding portion of the second end effector element 212, but with a gap therebetween such that the first coupling element 211 is not coupled to the second coupling element 212. The intermediate configuration can facilitate insertion of the end effector 204 into a target surgical site, such as within a patient's body.

[0069] 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 elongated body 205; in a second configuration, at least a portion of the second end effector element 208 is substantially perpendicular to the axis of the elongated body 205. As used herein, the term "substantially perpendicular" means within a range of + / - 10 degrees of perpendicularity or within a range of 80 to 90 degrees relative to the axis of the elongated body 205. For example, Figure 3BAs shown, the first step in the device workflow can include positioning the first clamp 207 perpendicular to the axis of the vascular actuator 206. The device joints 214, 213, 215 are appropriately articulated to achieve this configuration. For example, the distal end of the first articulation member 213 articulates around its proximal end toward the axis of the slender body 205, and the distal end of the second articulation member 214 articulates around its proximal end away from the axis of the slender body 205, so that at least a portion of the first end effector element 207 is oriented nearly perpendicular to the axis of the slender body 205. This thereby allows the vascular actuator 206 to be advanced through the first coupling ring 211. For example, the first coupling element 211 can be disposed in the receiving portion so that the hole of the first coupling element 211 is nearly aligned axially with the slender body 205 in the first configuration. Once the vascular actuator 206 has passed through the coupling ring 211, the vascular actuator 206 can be advanced into the lumen through the end of the first blood vessel V1.

[0070] Various positions of the end effector 204 can be achieved by controlling the drive of the articulated joint using, for example, tethers, cables, mechanical linkages, motors, electroactive polymers, magnets, push rods, translating pins, rivets, swivel joints, rotating pins, shafts, bearings, sleeve bearings, and / or combinations thereof. For example, in some embodiments, the device 200 may include: a first tether having a first distal end coupled to the first articulated member 213; and a second tether having a second distal end coupled to the second articulated member 214. The first tether and the second tether can move independently of each other to control the movement of the first articulated member and the second articulated member between the first configuration, the second configuration, and / or the third configuration. In other embodiments, the device 200 may include a tether having a first distal end coupled to the first articulated member 213 and a second distal end coupled to the second articulated member 214.

[0071] As a second step, Figure 3CAs shown, the vascular actuator 206 is actuated to engage the lumen of the first blood vessel V1. This allows a secure connection between the first blood vessel V1 and the vascular actuator 206 to allow the first blood vessel V1 to pass through the coupling ring 211. In the first configuration, the vascular actuator 206 can be configured so that the axial end of the first blood vessel V1 is received in the first coupling element 211. For example, in the first configuration, the vascular actuator 206 can be configured to translate through the first coupling element 211. The vascular actuator 206 can also be configured to grab, fix, clamp or otherwise capture the axial end of the first blood vessel V1 and pull it back through the hole of the first coupling element 211. The vascular actuator 206 can engage the lumen of the first blood vessel V1 using a mechanical mechanism, such as but not limited to an expansion basket, an expansion wire, an opening mechanism, negative pressure, vacuum, suction, barbs, hooks, tacks, etc. The vascular actuator 206 is then withdrawn into the body internal passage 209 via the coupling ring 212, thereby advancing the blood vessel V1 together with the vascular actuator 206. Once the end of the first blood vessel V1 has successfully passed through the coupling ring, the vascular actuator 206 can be further actuated to facilitate coupling the blood vessel V1 to the coupling ring 212. The connection of the blood vessel end of the first blood vessel V1 to the coupling ring 211 can be facilitated by everting or opening the blood vessel end. This eversion of the blood vessel end can be achieved by the vascular actuator 206 by mechanically, hydraulically or pneumatically expanding the connection between the blood vessel actuator and the blood vessel. Once the blood vessel V1 is connected to the coupling ring 212, the connection between the blood vessel V1 and the vascular actuator 206 can be cut off, and then the vascular actuator 206 can be relaxed and withdrawn (e.g., completely or partially) into the body internal passage 209. For example, the first coupling element 211 can include a fixing member on its inner surface, such as a pin, a hook, a recess, a pawl or any other fixing member. Everting of the axial end of the first blood vessel V1 can cause the fixing member to fix the axial end of the first blood vessel V1, for example by piercing the wall of the first blood vessel V1, so that when the blood vessel actuator 206 is withdrawn from the first blood vessel V1, the axial end of the first blood vessel V1 remains fixed to the first connector element 207.

[0072] The above configuration and position can be controlled from the proximal end of the device by an appropriate linkage mechanism through the body 205.

[0073] The above procedure can be repeated for the second blood vessel V2, such as Figure 3D and Figure 3EAs shown. For example, the distal end of the first hinge member 213 is articulated around its proximal end away from the axis of the slender body 205, and the distal end of the second hinge member 214 is articulated around its proximal end toward the axis of the slender body 205, so that at least a portion of the second end effector element 208 is oriented almost perpendicular to the axis of the slender body 205, and the hole of the second coupling element 212 is almost axially aligned with the axis of the slender body 205. The blood vessel actuator 206 can be configured so that in the second configuration, the axial end of the second blood vessel V2 is received in the second coupling element 212, and the axial end of the second blood vessel V2 is coupled to the second coupling element 212, as described with respect to the first configuration. Once the attachment of the second blood vessel is completed, both blood vessels are attached to their respective anastomotic coupling rings. The end effector 204 can be articulated to bring the two clamps 207, 208 together by moving the end effector 204 to the third configuration. For example, one or more additional actuators, such as tethers, ropes, wires, or other actuators, may be coupled to the first and / or second articulated members 213, 214, or may be coupled to the first and / or second end effector elements 207, 208, and configured to move the distal ends of the first and second articulated members 213, 214 toward each other. This causes the distal ends of the first and second end effector elements 207, 208 to articulate about the distal articulated member 215, causing the proximal ends of the first and second end effector elements 207, 208 to displace closer to each other until the end effector 204 is closed. This action engages the coupling elements 211, 213 together, as shown in FIG. Figure 3F Shown

[0074] Then, the vascular actuator 206 can be advanced through the distal channel 210 to separate the anastomotic vascular line AL, such as Figure 3G and Figure 3HAs described previously herein, the first end effector element 207 defines a first channel 207a and the second end effector element 208 defines a second channel 208a, which are continuous with the holes defined in the first and second end effector elements 207, 208 for holding the first and second coupling elements 211, 212, so that in the third configuration, the vascular actuator 206 can be moved axially into the channel 207a / b until the head end of the vascular actuator 206 contacts the coupling elements 211, 212. The distal hinge member 215 defines an opening 217, which is continuous with the channel 207a / b in the third configuration. The continuous displacement of the vascular actuator 206 through the channels 207a, 208a pushes the first and second coupling elements 211, 212 coupled to each other out of their respective holes, into and through the opening 217, until the coupling elements 211, 212 are removed from the end effector 204.

[0075] Figure 4A-4F An exemplary embodiment of a laparoscopic stapling device 300 is shown along with steps for creating an anastomosis. Figure 4A-4F The laparoscopic device shown can be structurally and / or functionally similar to other devices described herein, including, for example, with reference to Figure 3A-3H The device described. Figure 4A A perspective view of the end effector is shown, which is in a stowed state to allow the device to pass through a small opening. Each end effector may include a clamp 302, a connector element 303, and an articulation member 304. In addition, the two end effectors may be connected at the distal end 301 using one or more of the following connection methods, including but not limited to a swivel pin, a cable, a mechanical linkage, a sliding linkage, a living hinge, a hinge mechanism, a magnetic connection, and an electromagnetic connection. In some embodiments, the distal end 301 may be configured to enable articulated movement when the elements of the clamp 302 are translated. For example, the distal end may include a longitudinal slit in which a pin is disposed that connects a first clamp element of the clamp 302 to a second clamp element. The pin can allow the clamp elements of the clamp 302 to rotate relative to each other to move from an open configuration to a closed configuration. In addition, the pin can be configured to slide in the longitudinal slit, such as in the closed configuration of the clamp 302, to allow the elements of the clamp 302 to slide toward (or away from) each other. This can help align the coupler elements 303 disposed in each clamp element with each other and allow the clamp elements 302 and thereby the coupler elements 303 to move toward each other to couple the coupler elements and anastomose the axial ends of two blood vessels as previously described herein.

[0076] Figure 4B and Figure 4CA perspective view of exemplary positions is provided that allow the vessel actuator 305 to be advanced through the coupling ring (coupler element) 303, the vessel axial end to engage the vessel actuator, or the connection to be transferred from the vessel actuator and the vessel to the vessel and the coupler element. The articulated member 304 including the end effector can be coupled to the distal end of the elongated body by using a mechanical linkage 308. FIG. 4C shows a detailed view of such a mechanical linkage 308. For example, in some embodiments, the mechanical linkage 308 can be configured to allow the articulated member that couples the end effector 304 to the device body 305 to slide or translate along a side of the device body 305. This can allow the articulated members of the end effector 304 to translate proximally or distally independently of each other, thereby facilitating translation and rotation of the end effector 304 in various directions. In various embodiments, the mechanical linkage 308 can include a slit defined in a side wall of the device body 305 and a sliding linkage coupled to the slit or to a coupler within the slit, thereby allowing for an increased range of motion.

[0077] Figure 4D 303 is a perspective view of another exemplary position of a laparoscopic stapling device, which allows the first coupling element to be coupled to the second coupling element by bringing the first end effector element and the second end effector element closer to each other, thereby achieving the coupling of two blood vessels. The end effector element allows the blood vessel end to pass through the opening 316 in the end effector element and allow connection to the coupling element 303.

[0078] Figure 4E An example of a vascular actuator 305 is shown that may be used to disconnect the coupling element 303 from the rest of the laparoscopic stapling device. Figure 4F An exemplary embodiment of coupling elements 321 , 322 is shown in a mated configuration.

[0079] The coupling elements 321, 322 may include an annular body with a plurality of pins, the two coupling elements having a plurality of holes so that the pins are aligned with the holes when the two coupling elements approach each other. The annular body and the pins may include, for example, plastic, metal, 3D printed polymers, biodegradable materials, or a combination thereof.

[0080] Figure 5A-Figure 5B A flow chart of a method 10 for completing anastomosis of one blood vessel to another blood vessel using an exemplary device or surgical instrument according to an embodiment is shown. 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. Ligating the second tubular tissue structure. The method 10 may also include closing at least a portion of the first tubular tissue structure and the second tubular tissue structure to prevent blood loss.

[0081] The first clamp arm and the second clamp arm can be moved to an open configuration. Method 10 may also include passing at least a portion of the first tubular tissue structure through a first connector ring of the first clamp arm of the surgical instrument, and passing at least a portion of the second tubular tissue structure through a second connector ring of the second clamp arm of the surgical instrument. Method 10 may also include fixing at least a portion of the first tubular tissue structure and the second tubular tissue structure to at least a portion of the first clamp arm and the second clamp arm, causing a configuration change of the first clamp arm and the second clamp arm to securely engage the first tubular tissue structure and the second tubular tissue structure. The configuration of the end effector of the surgical instrument can be changed to separate the first tubular tissue structure and the second tubular tissue structure from the distal side of the surgical instrument. The configuration of the first clamp arm and the second clamp arm can be changed to move the clamp arms to a closed configuration, and the surgical instrument can be separated from the target surgical site. The first tubular tissue structure and the second tubular tissue structure can be opened to enable fluid to flow between them.

[0082] Complete closure of the clamp arms of any end effector described herein is desirable, for example, because incomplete closure can result in possible leakage, clotting, and bleeding. The clamp arms can be configured to mate with each other and overcome friction associated with mating of the coupler rings, for example, where the pins of the rings need to slide into corresponding holes. The closure force can be increased by adding elements to the end effector. Such elements can include, for example, a sheath (e.g., sheath 10, Figure 1B ), the sheath can be used to externally compress the clamp arms together. In some embodiments, a mechanical linkage or pull line inside the clamp arms can be used to pull the two clamp arms closer to each other. In some embodiments, suitable elements for closing the two clamp arms can include magnets, electromagnets, compression using pneumatic and / or hydraulic elements. Additionally or alternatively, the clamp arms can include an ultrasonic transducer that helps overcome friction when the pins of the coupling ring slide into the corresponding snap-fit ​​channels or holes.

[0083] In further detail, method 10 may include preparing a first tubular tissue structure for anastomosis at 11, for example, by isolating and ligating the first tubular tissue structure (e.g., a first blood vessel). At 12, preparing a second tubular tissue structure for anastomosis, for example, by isolating and ligating the second tubular tissue structure (e.g., a second blood vessel). At 13, preparing a surgical instrument (e.g., device 200), for example, by loading coupling rings 211, 212 into end effectors 207, 208. At 14, introducing the surgical instrument to a target surgical site, for example, by making an incision in a patient's body and moving device 200 to an intermediate configuration.

[0084] At 15, the external surgical instrument is configured for mode one, for example, by moving the end effector 204 to a first configuration to align the distal clamp one (i.e., the first end effector element 207) perpendicular to the vascular actuator 206 or the internal device. At 16, the vascular actuator 206 is advanced through the first end effector element 207 and into the first tubular structure. At 17, the first use mode of the vascular actuator 206 is actuated, wherein the vascular actuator 206 is advanced through the first coupling element 211, secures the end of the first tubular structure, and advances the end into the first coupling element 211. At 18, the second use mode of the vascular actuator 206 is initiated, wherein the vascular actuator 206 everts the end of the first tubular structure and passes the end through a corresponding pin of the first coupling element. At 19, the vascular actuator 206 is retracted into the elongated body 205.

[0085] At 20, the external surgical instrument is again configured for mode one, for example, by moving the end effector 204 to a second configuration to align the distal clamp two (i.e., the second end effector element 208) perpendicular to the vascular actuator 206. At 21, the vascular actuator 206 is advanced through the second end effector element 208 and into the second tubular structure. At 22, the first use mode of the vascular actuator 206 is actuated, wherein the vascular actuator 206 is advanced through the second coupling element 212, secures the end of the second tubular structure, and advances the end into the second coupling element 211. At 23, the second use mode of the vascular actuator 206 is initiated, wherein the vascular actuator 206 everts the end of the second tubular structure and passes the end through a corresponding pin of the second coupling element. At 24, the vascular actuator 206 is retracted into the elongated body 205.

[0086] At 25, the surgical device is configured for mode three, e.g., preparing the end effector 204 to move to the third configuration. At 26, mode three is actuated by closing the first and second end effector elements 207, 208, thereby engaging the first and second coupling elements 211, 212 by moving the end effector 204 to the third configuration. At 27, the vascular actuator is advanced through the end effector 204 to eject the coupling elements 211, 212 from the end effector 204. At 28, the surgical instrument is retracted and removed from the target surgical site.

[0087] Figure 6A perspective view of a device 400 according to an embodiment is shown. The device 400 is substantially similar to the devices 200 and 300 described previously herein, and includes an elongated body 405, a vascular actuator 406 disposed through the elongated body 405, and an end effector 404, the end effector including a first end effector element 407, a second end effector element 408, a first articulation member 413, a second articulation member 414, and a distal articulation member 415, which are substantially similar in structure and function to the elongated body 205, the vascular actuator 206, the first end effector element 207, the second end effector element 208, the first articulation member 213, the second articulation member 214, and the distal articulation member 215 as described previously herein. The first and second end effector elements 407, 408 define receiving portions 419a, 419b, in which the first and second coupling elements (e.g., the first and second coupling elements 211, 212) can be disposed, respectively, as previously described herein. The end effectors 407, 408 also define an opening 417 for allowing the coupling element to be removed from the end effector 404 by the vascular actuator 406, as previously described herein.

[0088] A further breakdown of the device 400 can be seen in FIG7. Referring to FIG7- Fig.11 , the device 400 includes a first actuator 422a / b, a second actuator 424a / b, and a third actuator 426a / b, which are configured to cycle the end effector 404 through various actuation modes by changing the relative distances between the components 407, 408, 413, 414, and 415. Fig.11 As shown, the actuators 422a / b, 424a / b, and 426a / b include tethers, but in other embodiments, any suitable actuators may be included, such as ropes, wires, pulleys, pins, rods, etc. In the illustrated embodiment, the change in distance is achieved by applying tension on three sets of actuators 422a / b, 424a / b, and 426a / b in different configurations, which are shown as wires, for a total of six wires, three on the right side (R) and three on the left side (L). The final desired position output, the right cage configuration of the end effector 404, the middle cage configuration of the end effector 404, the left cage configuration, and the stowed cage configuration can determine the tension combination, that is, the tension applied to one or more of the actuators 422a / b, 424a / b, 426a / b. The tension can be divided into three categories: off, medium, and on. Where "off" means that the force applied to the desired line is zero, "medium" means that the line is held taut, and "on" means that the line has been pulled to the maximum range of motion that can be displaced. Fig.11 The different combinations of tension required from each set of wires to output the desired distal pattern are broken down.

[0089] The first actuator 422a / b (also referred to herein as "distal wire 422a / b") may include wires coupled to the first end effector element 407 and the second end effector element 408b, respectively, by being inserted into slits 421a / b defined on outer surfaces of the first end effector element 407 and the second end effector element 408, respectively. Pulling the first actuator 422a / bb causes the first end effector element 407 and the second end effector element 408 to articulate about the distal hinge member 415, thereby causing the first end effector element 407 and the second end effector element 408 to articulate about their respective proximal ends to move the end effector 404 to an open configuration, such as Figure 7B 4. Unlike the end effectors 205, 305, the distal ends of the first and second end effector elements 407, 408 and / or the distal hinge member 415 are shaped to form a distal terminal stop 416 that limits the angular movement of the first and second end effector elements 407, 408 and, thereby, the end effector 404. For example, the distal terminal stop 416 may include angled distal ends of the first and second end effector elements 407, 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, 408 away from each other, thereby preventing the end effector 404 from further opening. In some embodiments, the distal terminal stop 416 may be configured to limit the articulated movement of the first and second end effector elements 407, 408 about their respective distal ends to an angle α that is less than 180 degrees. Thus, the distal end stop 416 limits the maximum angle that the end effector elements 408 and 407 can open, for example, to ensure proper alignment. As described herein, this can advantageously help position the end effector 404 in a desired orientation in the first configuration and the second configuration.

[0090] Figure 8A-B Further description is given by showing various mechanical features Figure 6 and Figure 7A-7B The device 400 shown. The device 400 can be cycled through different modes by moving the distal components so that they are located more proximally. In this embodiment, this is achieved by a wire that reduces the distance between the proximal components 407, 408, 413, 414, and 415 when the wire is pulled proximally. Figure 7B The same embodiment is shown after the wire has been pulled, showing the reduction in distance of the end effector elements 407 , 408 and the engagement of the distal terminal stop 416 .

[0091] Figure 8A-BA second actuator 424a / b is shown that is coupled to the first and second articulated members 413, 414 and may include a tether or wire (also referred to herein as a "distal stop wire 424a / b"). Figure 8A-B As shown, the second actuator 424a / b is coupled to the first slit 423a / b defined near the proximal ends of the first and second hinge members 413, 414, respectively. The distal terminal stop wires 424a / b are the distal-most wires that pull the first and second hinge members 413, 414. When a pulling force is applied to the distal terminal stop wires 424a / b, the motion output depends on which wire is pulled, and the wires can move equal distances (L=R) in opposite directions from each other, configured to cause a seesaw-like motion of the end effector 404. For example, pulling the second actuator 424b while letting the second actuator 424a move will cause the end effector 404 to move to the distal end. Figure 8B The first configuration shown and vice versa.

[0092] Figure 9A-9D A third actuator 426a / b (also referred to herein as a "stowed mode wire 426a / b") is shown coupled to the first and second articulated members 413, 414 and configured to stow the first and second end effectors 407, 408 to move the end effector 404 to a third configuration. The third actuator 426a / b may be shown as comprising a tether or wire, but may comprise any other actuator described herein. Fig. 9A As shown, the distal ends of the stowed mode lines 426a / b are respectively coupled to the second slits 425a, 425b defined on the first and second hinge members 413, 414. The second slits 425a / b can be defined at a position distal to the first slits 423a / b on the first and second hinge members 413, 414, but can be located at any suitable position on the first and second hinge members 413, 414 in other embodiments.

[0093] The stowed mode lines 426a / b can apply a pulling force on the first and second hinge members 413, 414 to articulate the distal ends of the first and second hinge members 413, 414 toward each other, thereby returning the first and second end effector elements 407, 408 to the stowed state when the first and second end effector elements 407, 408 are in any other mode (e.g., the first configuration or the second configuration, or any other orientation). When a pulling force is applied to the stowed mode lines 426a / b, the motion output is independent, (L≠R), meaning that the action of pulling one side (left or right) does not necessarily affect the opposite side in this embodiment. The second actuator 424a / b applies a pulling force on the first and second hinged members 413, 414 and allows these components to swing further to the left or further to the right depending on whether the left or right second actuator 424a / b has a greater pulling force applied thereto, thereby producing a seesaw effect as described above, (L=R). Figure 8A-B The second actuator 424a / b is highlighted. Fig. 8A , the end effectors 407, 408 are in the stowed mode before a pulling force is applied to the second actuators 424a, 424b. As a result, when a pulling force is applied to the left second actuator 424b (open), the second hinge member 414 articulates radially outward and the first articulated member 413 articulates radially inward, causing the first end effector element 407 to move to a vertical position relative to the elongated body 405. The same is true if a pulling force is applied to the right second actuator 424a, which will cause the second end effector element 408 to be oriented perpendicular to the elongated body 405.

[0094] Fig. 9A - Figure 9D highlights the stowed mode lines 426a / b. Fig. 9A , before a tension is applied to the stowed mode lines 426a / b, the first and second hinge members 413, 414 are in the intermediate cage configuration. Thus, when a tension is applied to the right and left stowed mode lines 426a / b (open), an inward biasing force is applied to the first and second hinge members 413, 414, thereby causing the first and second end effector elements 407, 408 to close the end effector 404 and move the end effector 404 to the stowed cage configuration, as shown. Figure 9B-9D shown.

[0095] Figure 10A-10C The concepts of different cage configurations are shown in more detail. Fig. 10A The end effector 404 is shown in a first configuration (right cage configuration), Fig. 10C The end effector 404 is shown in a second configuration (left cage configuration), Fig. 10CThe end effector 404 is shown in an intermediate cage configuration between the first and second configurations. The arrows indicate end effector elements 407, 408 and / or articulated members 413, 414 that are subject to tension. Figure 10A-10C In the figure, the line without arrows indicates that the end effector elements 407, 408 and the hinge members 413, 414 are not subjected to tension. In some embodiments, the end effector 404 may also include hinge pins disposed at the first and second hinge members 413, 414 and the proximal and distal ends of the first and second end effector elements 407, 408, for coupling the first and second end effector elements 413, 414 to the elongated body 405, coupling the distal ends of the first and second end hinge members 413, 414 to the proximal ends of the first and second end effector elements 407, 408, and coupling the distal ends of the first and second end effector elements 407, 408 to each other (e.g., via the distal hinge member 415). In some embodiments, the end effector 404 may also include a terminal stop pin disposed at any suitable position on the end effector 404. The terminal stop pins may be configured to limit angular movement or displacement of the first and second end effector elements 407, 408 and / or the first and second hinge members 413, 414. This may advantageously prevent the end effector 404 from moving in the cage configuration to an orientation such that the stowed mode lines 426a / b do not enable the end effector 404 to move to the stowed configuration. Fig.11 Each end effector 404 is shown in right cage, middle cage, and left cage configurations, and the first actuator 422a / b, second actuator 424a / b, and / or third actuator 426a / b actuated to achieve each of these configurations.

[0096] Figure 12A-12C A perspective view of a device 500 according to another embodiment is shown. The device 500 is substantially similar to the device 400 described previously herein and includes an elongated body 505, a vascular actuator 506 disposed through the elongated body 505, and an end effector 504, the end effector 504 including a first end effector element 507, a second end effector element 508, a first articulation member 513, a second articulation member 514, and a distal articulation member 515, which are substantially similar in structure and function to the elongated body 405, vascular actuator 405, first end effector element 407, second end effector element 408, first articulation member 413, second articulation member 414, and distal articulation member 415 as described previously herein.

[0097] Unlike device 400, end effector 504 of device 500 further includes alignment features for aligning first and second end effector elements 507, 508 and first and second hinge members 513, 514 for proper closure in the third configuration, and for axially aligning vascular actuator 506 with the first or second coupler element (e.g., first and second coupler elements 211, 212) in the first and second configurations. For example, as Figure 12A-12C As shown, the first and second hinge members 513, 514 include first alignment features 532 (e.g., pins, protrusions, recesses, detents, slits, cavities, etc.), and the first and second end effector elements 507, 508 include second alignment features 534 (e.g., pins, protrusions, recesses, detents, slits, cavities, etc.) configured to cooperate with the corresponding first alignment features 532. The first and second alignment features 532 are configured to facilitate proper alignment and closure of the end effector elements 507, 508 and the first and second hinge members 513, 514 when in the stowed state configuration (i.e., the third configuration). In this way, the first and second alignment features 532, 534 help to align and engage the first coupling element coupled to the first end effector element 507 with the second coupling element coupled to the second end effector element 508 in the third configuration.

[0098] The end effector 504 also includes: a first end effector alignment member 536a, which is disposed on the first hinge member 513 and is configured to align the vascular actuator 506 with the first coupling element in the first configuration; and a second end effector alignment member 536b, which is disposed on the second hinge member 514 and is configured to align the vascular actuator 506 with the second coupling element in the second configuration. The first and second end effector alignment members 536a, 536b can facilitate the upward travel of the vascular actuator 406 while maintaining axial alignment relative to the first or second end effector elements 407, 408 depending on the cage configuration. In some embodiments, the first and second end effector alignment members 536a / b may include an annular or arched structure coupled to the inner surface of the first and second hinge members 513, 514. The first end effector alignment member and the second end effector alignment member 536a / b define a through hole through which the vascular actuator 506 is inserted to approach the corresponding coupling element. When the vascular actuator 506 is inserted through the first end effector alignment member or the second end effector alignment member 536a / b, the inner surface of the first end effector alignment member or the second end effector alignment member 536a / b in the first configuration or the second configuration can contact the outer surface of the vascular actuator 506 and inhibit the lateral movement of the vascular actuator 506 to keep the vascular actuator 506 aligned with the corresponding first coupling element or the second coupling element. The first end effector alignment member and the second end effector alignment member 536a / b can be configured to be retractable, for example, in the third configuration to allow the end effector 504 to be closed. In some embodiments, the first end effector alignment member 536a can be configured to move from a stowed configuration to a deployed configuration in a first configuration, and the second end effector alignment member 536b can be stowed in the first configuration, such as Fig. 12A As shown. The first end effector element and the second end effector element 536a / b can both be stowed in the intermediate cage configuration. Fig. 12B In addition, the second end effector alignment member 536b can be configured to move from the stowed configuration to the deployed configuration in the second configuration, and the first end effector alignment member 536b can be stowed in the second configuration, as shown. Fig. 12C shown.

[0099] In some embodiments, any of the end effectors described herein can be configured to articulate about the distal end of the elongated body or shaft assembly at an angle within a range of at least about 20 degrees (e.g., about 20, 40, 60, 80, 90, 100, 110, or 120 degrees, including all values ​​and subranges therebetween). This can enhance visibility of various elements that are critical to performing an anastomotic procedure.

[0100] As used herein, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, the term "component" is intended to mean a single component or a combination of components, and "material" is intended to mean one or more materials or a combination thereof.

[0101] As used herein, the terms "about" and "approximately" generally refer to plus or minus 10% of the listed value. For example, about 0.5 will include 0.45 and 0.55, about 10 will include 9 to 11, and about 1000 will include 900 to 1100.

[0102] As used herein, the term "substantially" and similar terms are intended to have a broad meaning consistent with the common and accepted usage by ordinary technicians in the field related to the subject matter of the present disclosure. For example, the term "substantially flat" would mean that there can be a minimal amount of surface differences or undulations caused by manufacturing differences that exist on an otherwise flat surface. It should be understood by those skilled in the art reading this disclosure that these terms are intended to allow description of certain features described and claimed, rather than limiting the scope of these features to the precise arrangement and / or numerical range provided. Therefore, these terms should be interpreted as indicating that insignificant or insignificant modifications or changes to the subject matter described and claimed are considered to be within the scope of the invention stated in the appended claims.

[0103] It should be noted that the term "exemplary" used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, representatives and / or illustrations of possible embodiments (such terms are not intended to imply that such embodiments are necessarily extraordinary or superlative examples).

[0104] As used herein, the terms "coupled" and the like refer to the joining of two members directly or indirectly to one another. Such joining may be fixed (e.g., permanent) or movable (e.g., removable or releasable). Such joining may be achieved by the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another, or by the two members or the two members and any additional intermediate members being attached to one another.

[0105] It is worth noting that the construction and arrangement of various exemplary embodiments are for illustration only. Although only a few embodiments are described in detail in this disclosure, those skilled in the art who read this disclosure will readily appreciate that many modifications are possible (e.g., changes in the size, dimensions, structure, shape and proportion of various elements, parameter values, mounting arrangements, materials used, colors, orientations, etc.) without departing from the scope of the present invention. Other substitutions, modifications, changes, and omissions may also be made in the design, operating conditions, and arrangements of various exemplary embodiments without departing from the scope of the present invention.

[0106] Although this specification contains many specific implementation details, these should not be regarded as limitations on the scope of any invention or the scope that may be claimed, but should be regarded as descriptions of the unique features of specific embodiments of specific inventions. Certain features described in the context of each separate embodiment in this specification may also be implemented in combination in a single embodiment. Conversely, the various features described in the context of a single embodiment may also be implemented separately in multiple embodiments or in any suitable sub-combination. In addition, although the features above may be described as acting in certain combinations and even if such protection is initially claimed, in some cases one or more features from the claimed combination may be deleted from the combination, and the claimed combination may be directed to a sub-combination or a variant of a sub-combination.

[0107] Thus, specific embodiments of the invention have been described. Other embodiments are also within the scope of the following claims. In some cases, the actions listed in the claims can be performed in a different order and still achieve the desired results. In addition, the methods depicted in the accompanying drawings do not necessarily require the specific order or sequential order shown to achieve the desired results. In some embodiments, multitasking and parallel processing may be advantageous.

Claims

1. A device comprising: Slender body; as well as An end effector coupled to the distal end of the elongated body, the end effector comprising: a first end effector element defining a first receiving portion configured to retain a first coupler element of the coupler; a first articulation member coupling the proximal end of the first end effector element to the elongated body; a second end effector element defining a second receiving portion configured to retain a second coupler element of the coupler; a second articulation member coupling the proximal end of the second end effector element to the elongated body; wherein the end effector is configured to move between: (i) a first configuration, wherein the first articulated member and the second articulated member configure the first end effector element and the second end effector element to allow the first axial end of the first blood vessel to be received into the first connector element; (ii) a second configuration different from the first configuration, wherein the first articulated member and the second articulated member configure the first end effector and the second end effector element to allow the second axial end of the second blood vessel to be received into the second connector element; and (iii) a third configuration, wherein the first articulated member and the second articulated member configure at least a portion of the first end effector element to be adjacent to a corresponding portion of the second end effector element such that the first connector element is coupled to the second connector element to couple the first blood vessel to the second blood vessel.

2. The apparatus according to claim 1, wherein: In the first configuration, at least a portion of the first end effector is substantially perpendicular to the axis of the elongated body; In the second configuration, at least a portion of the second end effector is substantially perpendicular to the axis of the elongated body.

3. The apparatus according to claim 2, wherein: In the first configuration, the bore of the first coupling element is nearly axially aligned with the elongated body; In the second configuration, the aperture of the second coupling element is nearly axially aligned with the elongated body.

4. The apparatus according to claim 1, further comprising: A vascular actuator is disposed through an interior passage defined by the elongated body and is configured to be axially displaceable through the interior passage to extend through the end effector.

5. The device according to claim 4, wherein: The vessel actuator is configured to cause an axial end of a first vessel to be received in the first coupler element in a first configuration and to cause an axial end of a second vessel to be received in the second coupler element in a second configuration.

6. The apparatus according to claim 4, further comprising: a first end effector alignment member disposed on the first articulation member and configured to align the vascular actuator with the first coupler element in a first configuration; and A second end effector alignment member is disposed on the second articulation member and is configured to align the vascular actuator with the second coupler element in the second configuration.

7. The apparatus of claim 4, wherein: Each of the first end effector element and the second end effector element defines a passage through at least a portion thereof; In a third configuration, the vessel actuator is configured to selectively translate along the axis of the interior passage to push the first and second coupler elements, and thereby the first and second blood vessels, out of the respective first and second receiving portions.

8. The device element according to claim 1, wherein: The first hinge member and the second hinge member include a first alignment feature; The first end effector element and the second end effector element include a second alignment feature; The first alignment feature and the second alignment feature are configured to facilitate alignment and engagement of the first coupling element with the second coupling element in the third configuration.

9. The apparatus according to claim 1, further comprising: A distal articulation member is coupled to the distal ends of the first and second end effectors, the distal articulation member being configured to allow the distal ends of the first and second end effector elements to articulate about each other.

10. The apparatus of claim 9, wherein: The distal articulation member defines an opening in the third configuration, the opening being continuous with the first and second receiving portions, the opening being configured to allow the first and second coupler elements to be removed from the first and second receiving portions via the opening, thereby releasing the coupler from the end effector.

11. The device according to claim 10, wherein: The distal articulation member includes a distal end stop member configured to limit articulated movement of the first end effector element and the second end effector element about their respective distal ends to an angle of less than 180 degrees.

12. The device according to claim 9, wherein: The distal articulation member is configured to further allow the first end effector element and the second end effector element to translate toward or away from each other in the third configuration.

13. The apparatus according to claim 1, wherein: The proximal ends of the first and second articulation members are configured to translate relative to the elongated body.

14. The apparatus according to claim 1, further comprising: A first actuator is coupled to the first end effector element and the second end effector element, the first actuator being configured to be engaged to articulately move the first end effector element and the second end effector element about their respective distal ends away from each other.

15. The apparatus according to claim 14, further comprising: a second actuator coupled to the first hinge member and the second hinge member at a first position of the first hinge member and the second hinge member, in: a second actuator coupled to the second hinge member configured to be displaced toward the elongated body to move the end effector to the first configuration; A second actuator coupled to the first hinge member is configured to be displaced toward the elongated body to move the end effector to the second configuration.

16. The apparatus according to claim 15, further comprising: a third actuator having a first distal end coupled to the first and second hinge members at a second position of the first and second hinge members different from the first position, in, The third actuator is configured to be engaged to move the end effector from the first configuration or the second configuration to a third configuration.

17. The device according to claim 16, wherein: At least one of the first actuator, the second actuator, or the third actuator includes a tether.

18. The apparatus according to claim 1, wherein: The end effector is further configured to be movable to an intermediate configuration in which the at least a portion of the first end effector element is adjacent to the corresponding portion of the second end effector element with a gap therebetween such that the first coupling element is not coupled to the second coupling element.

19. A device comprising: a first end effector element defining a first receiving portion configured to retain a first coupler element of the coupler; a first articulation member coupling a proximal end of the first end effector element to the elongated body; a second end effector element defining a second receiving portion configured to retain 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 end effector element and the second end effector element are capable of articulated movement about their respective distal ends; as well as a second articulation member coupling a proximal end of the second end effector element to the elongated body; wherein the end effector is configured to move between: (i) a first configuration, wherein the first articulated member and the second articulated member configure the first end effector element and the second end effector element to allow the first axial end of the first blood vessel to be received into the first connector element; (ii) a second configuration different from the first configuration, wherein the first articulated member and the second articulated member configure the first end effector and the second end effector element to allow the second axial end of the second blood vessel to be received into the second connector element; and (iii) a third configuration, wherein the first articulated member and the second articulated member configure at least a portion of the first end effector element to be adjacent to a corresponding portion of the second end effector element such that the first connector element is coupled to the second connector element to couple the first blood vessel to the second blood vessel.

20. The apparatus of claim 19, wherein: In a first configuration, at least a portion of the first end effector is configured to be disposed approximately perpendicular to an axis of the elongated body; In the second configuration, at least a portion of the second end effector is configured to be disposed approximately perpendicular to the axis of the elongated body.

21. The apparatus of claim 20, wherein: In the first configuration, the first receiving portion of the first coupling element is configured to be nearly axially aligned with the elongated body; In the second configuration, the second receiving portion of the second coupling element is configured to be nearly axially aligned with the elongated body.

22. The apparatus of claim 19, wherein: Each of the first end effector element and the second end effector element defines a channel through at least a portion thereof, and each of the channels is configured to receive a portion of a blood vessel actuator axially through the channel in a third configuration so that the blood vessel actuator can release the first and second connector elements and thereby the first and second blood vessels respectively connected to the first and second connector elements from the end effector.

23. The apparatus of claim 19, further comprising: A distal articulation member is coupled to the distal ends of the first and second end effectors, the distal articulation member being configured to allow the distal ends of the first and second end effector elements to articulate about each other.

24. The apparatus of claim 23, wherein: The distal articulation member defines an opening in the third configuration, the opening being continuous with the first and second receiving portions, the opening being configured to allow the first and second coupler elements to be removed from the first and second receiving portions via the opening, thereby releasing the coupler from the end effector.

25. The apparatus of claim 24, wherein: The distal articulation member includes a distal end stop member configured to limit articulated movement of the first end effector element and the second end effector element about their respective distal ends to an angle of less than 180 degrees.

26. The apparatus of claim 19, further comprising: a first end effector alignment member disposed on the first articulation member and configured to align the vascular actuator with the first coupler element in a first configuration; and A second end effector alignment member is disposed on the second articulation member and is configured to align the vascular actuator with the second coupler element in the second configuration.

27. The apparatus of claim 19, wherein: The first hinge member and the second hinge member include a first alignment feature; The first end effector element and the second end effector element include a second alignment feature; The first alignment feature is configured to facilitate engagement of the first coupler element with the second coupler element in the third configuration.

28. The apparatus of claim 19, wherein: The end effector is further configured to move to an intermediate configuration in which the at least a portion of the first end effector element is proximate to the corresponding portion of the second end effector element with a gap therebetween such that the first coupler element is not coupled to the second coupler element.

29. A method for anastomosing a first blood vessel to a second blood vessel in a patient, comprising: inserting a distal end of an elongated body of the device into a patient, an end effector coupled to the distal end of the elongated body, the end effector comprising a first end effector element coupled to the elongated body by a first hinge member and a second end effector element coupled to the elongated body by a second hinge member; moving the end effector to a first configuration in which at least a portion of the first end effector is substantially perpendicular to the axis of the elongated body; inserting an axial end of a first blood vessel through a first coupler element coupled to a 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 substantially perpendicular to the axis of the elongated body; inserting an axial end of a second blood vessel through a second coupler element coupled to the second end effector element; moving the end effector to a third configuration such that at least a portion of the first end effector element moves proximate 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 blood vessel to the second blood vessel; The first coupler element is released from the first end effector element, and the second coupler element is released from the second end effector element.

30. The method of claim 29, further comprising: disposing a first coupler element in a first receiving portion of a first end effector element; and The second coupling element is disposed in the second receiving portion of the second end effector element.

31. The method of claim 29, further comprising: after inserting the axial end of the first blood vessel through the first coupler element, everting the axial end of the first blood vessel to couple the axial end of the first blood vessel to the first coupler element; and After inserting the axial end of the second blood vessel through the second coupler element, the axial end of the second blood vessel is everted to couple the axial end of the second blood vessel to the second coupler element.

32. The method of claim 29, further comprising: prior to inserting the elongated body into a patient, ligating the first blood vessel; and Ligate the second blood vessel.

33. The method of claim 29, further comprising: Prior to inserting the distal end of the elongated body into a patient, the end effector is moved to an intermediate configuration in which at least a portion of the first end effector element is adjacent to a corresponding portion of the second end effector element but with a gap therebetween so that the first connector element is not coupled to the second connector element.

34. A method for anastomosis, the method comprising: After the end effector of the stapling device has been positioned within the patient, converting the end effector to a first configuration; receiving an axial end of a first blood vessel via a first coupling element mounted to a first portion of the end effector when the end effector is in a first configuration; transforming the end effector to a second configuration different from the first configuration; receiving an axial end of a second blood vessel via a second coupling element mounted to a second portion of the end effector when the end effector is in a second configuration; converting 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 to couple the first coupler element to the second coupler element to couple the first blood vessel to the second blood vessel; and The first coupling element and the second coupling element are released from the end effector.

35. The method of claim 34, wherein: Transitioning to the first configuration includes orienting a first portion of the end effector substantially perpendicular to an elongated body coupled to the end effector; Transitioning to the second configuration includes orienting the second portion of the end effector approximately perpendicular to the elongated body.

36. The method of claim 34, further comprising: After inserting the axial end of the first blood vessel through the first coupler element, activating the blood vessel actuator to evert the axial end of the first blood vessel to couple the axial end of the first blood vessel to the first coupler element; and After the axial end of the second blood vessel is inserted through the first coupler element, the blood vessel actuator is activated to evert the axial end of the second blood vessel, thereby coupling the axial end of the second blood vessel to the second coupler element.

37. The method of claim 34, further comprising: Prior to positioning the end effector within the patient, the end effector is transformed into an intermediate configuration in which at least a portion of the first end effector element is proximate to a corresponding portion of the second end effector element but with a gap therebetween such that the first coupling element is not coupled to the second coupling element.

Images