Laparoscopic anastomosis device and method of use thereof

Abstract

The device includes an interface and an elongate body coupled to the interface. An end effector is coupled to a distal end of the elongate body and includes a first end effector element defining a first receptacle structured to hold a first coupler element of a coupler that receives an axial end of a first vessel and a second end effector element defining a second receptacle structured to hold a second coupler element of a coupler that receives an axial end of a second vessel. The end effector is configured to move between a first configuration in which the first and second end effector elements are separated and a second configuration in which the first coupler element is coupled to the second coupler element such that the first end effector element is proximate to the second end effector element, thereby coupling the first vessel to the second vessel.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority and the benefit of U.S. Provisional Application No. 63 / 164,493, filed on March 22, 2021, entitled "Devices and Methods for Anastomosis", the entire disclosure of which is incorporated herein by reference.

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

[0003] (Field of the Invention) The embodiments described herein generally relate to devices for performing laparoscopic anastomosis of two tubular structures.

Background Art

[0004] An anastomosis is a connection between two luminal structures. Generally, an anastomotic connection is surgically formed on a blood vessel (such as a vein or artery) or a tubular gastrointestinal structure (such as the intestine). Conventional techniques allow the anastomosis to be completed between two ends (referred to as end - to - end anastomosis) or between the end of one structure and the side of another structure (referred to as end - to - side anastomosis). Procedures that require these anastomoses are performed thousands of times a day worldwide. Similarly, in multiple surgical specialties, reliable, non - occluded anastomoses are relied upon to successfully treat their respective patients. Surgical reattachment of veins and arteries (sometimes also referred to simply as anastomosis in this specification) helps to restore blood circulation, thereby improving the supply of oxygen and other nutrients to downstream tissues and also improving the return of deoxygenated blood from tissues to the circulatory system. Therefore, it is desirable to reliably perform various vascular anastomosis procedures using minimally invasive procedures and reducing complexity.

Summary of the Invention

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

[0006] In some embodiments, the device includes an interface and an elongated body coupled to the interface and extending longitudinally from the interface. An end effector is coupled to the distal end of the elongated body. The end effector includes a first end effector element defining a first receptacle structured to hold a first coupler element of the coupler, wherein the first portion of the coupler is configured to receive the axial end of a first blood vessel; and a second end effector element defining a second receptacle structured to hold a second coupler element of the coupler, wherein the second portion of the coupler is configured to receive the axial end of a second blood vessel. The end effector is configured to move between a first configuration in which at least a portion of the first end effector element is separated from the corresponding portion of the second end effector element, thereby separating the first coupler element from the second coupler element, and a second configuration in which at least a portion of the first end effector element is in close proximity to the corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element so as to connect the first vessel to the second vessel.

[0007] In some embodiments, the device includes an elongated body and an end effector coupled to the distal end of the elongated body. The end effector includes a first end effector element defining a first receptacle structured to hold a first coupler element of a coupler, wherein the first coupler element is configured to receive the axial end of a first blood vessel, and a second end effector element defining a second receptacle structured to hold a second coupler element of a coupler, wherein the second coupler element is configured to receive the axial end of a second blood vessel. A fixing mechanism is operably coupled to the end effector and is configured to fix at least one of the first coupler element or the second coupler element in a first configuration of the end effector. The end effector is configured to move between a first configuration in which at least a portion of the first end effector element is separated from the corresponding portion of the second end effector element, thereby separating the first coupler element from the second coupler element, and a second configuration in which at least a portion of the first end effector element is in close proximity to the corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element so as to connect the first vessel to the second vessel.

[0008] In some embodiments, a method is provided for anastomosing a first blood vessel with a second blood vessel in a patient's body via an apparatus comprising an interface, an elongated body coupled to the interface, and an end effector including a first end effector element and a second end effector element. The method includes inserting the distal end of the elongated body into the patient's body. The end effector is moved to a first configuration in which at least a portion of the first end effector element is separated from the corresponding portion of the second end effector element, such that a first coupler element coupled to the first end effector element is separated from a second coupler element coupled to the second end effector element. The axial end of the first blood vessel is inserted through the first coupler element. The axial end of the second blood vessel is inserted through the second coupler element. The end effector is operated to move at least a portion of the first end effector element closer to the corresponding portion of the second end effector element so that the first coupler element is coupled to the second coupler element, thereby coupling the first blood vessel to the second blood vessel. In some embodiments, the method may also include releasing the first coupler element from the first end effector element and the second coupler element from the second end effector element, and withdrawing the elongated body from the patient's body.

[0009] It should be understood that all combinations of the aforementioned concepts and additional concepts described in more detail below (where such concepts are not contradictory) are intended to be part of the subject matter of the invention disclosed herein. In particular, all combinations of the claimed subject matter appearing at the end of this disclosure are intended to be part of the subject matter of the invention disclosed herein. [Brief explanation of the drawing]

[0010] The features described herein and other features will become more fully apparent from the following description and the attached claims, in conjunction with the attached drawings. While understanding that these drawings only illustrate some of the implementations described herein and should therefore not be considered limiting, the disclosure is described with additional specificity and detail through the use of the attached drawings. [Figure 1A] This is a schematic diagram of a device for performing laparoscopic anastomosis of two blood vessels according to one embodiment. [Figure 1B] This is a schematic diagram of the distal portion of the apparatus in Figure 1A, showing a first blood vessel and a second blood vessel connected to each other via the apparatus in Figure 1A, according to one embodiment. [Figure 2] This is a schematic flowchart of a method for laparoscopically connecting a first blood vessel to a second blood vessel, according to one embodiment. [Figure 3] This shows a side perspective view of an anastomosis device with an end effector according to one embodiment, and an enlarged view of the end effector in one configuration. [Figure 4A] Figure 3 shows a top perspective view of the end effector in the first configuration inside the patient's body, where the first blood vessel is inserted through the first coupler element of a coupler connected to the first end effector element, and the second blood vessel is inserted through the second coupler element of a coupler connected to the second coupler element of the coupler. [Figure 4B] This is a top perspective view of an end effector in a second configuration in which a first coupler element is coupled to a second coupler element to connect a first blood vessel to a second blood vessel. [Figure 4C] The image shows the device detached from the coupler, with the coupler remaining inside the patient's body, and the first blood vessel connected to the second blood vessel. [Figure 5] A shows a partial side perspective view and a side view of the anastomosis device in a first (open) configuration according to one embodiment. B shows a partial side perspective view and a side view of the device of Figure 5A in a third or intermediate (delivery) configuration. C shows a partial side perspective view and a side view of the device of Figure 5A in a second (closed) configuration. [Figure 6]A is a top view of a portion of the anastomosis device in a second (closed) configuration according to one embodiment, and B is a side view of a portion of the anastomosis device in a second (closed) configuration according to one embodiment. C is a top view of a portion of the device in a first (open) configuration, and D is a side view of a portion of the device in a first (open) configuration. E is a schematic diagram of the trajectory of the end effector of the devices in Figures 6A to 6D between the first and second configurations. [Figure 7] A is a front view of a portion of the anastomosis device in a second (closed) configuration according to one embodiment; B is a side perspective view of a portion of the anastomosis device in a second (closed) configuration according to one embodiment; C is a top view of a portion of the anastomosis device in a second (closed) configuration according to one embodiment. D is a top view of a portion of the device in a first (open) configuration; and E is a side perspective view of a portion of the device in a first (open) configuration. [Figure 8] A is a top view of the apparatus, including an elastic element and a closing element, according to one embodiment, and B is a front view of the apparatus, including an elastic element and a closing element, according to one embodiment. [Figure 9] A is a top view of a part of an anastomosis device, which includes an end effector in a second (closed) configuration according to one embodiment, comprising a first end effector element and a second end effector element configured to bend along its longitudinal axis, and B is a top view of the device in a first (open) configuration according to one embodiment. [Figure 10] A is a top view of an anastomosis device including a biasing member in a second (closed) configuration according to one embodiment, and B is a side view of an anastomosis device including a biasing member in a second (closed) configuration according to one embodiment. C is a top view of the device of Figure 10A in a first (open) configuration, and D is a side view of the device of Figure 10A in a first (open) configuration. [Figure 11] This is a side view of an end effector that may be included in an anastomosis device according to one embodiment. [Figure 12] A is a side view of a part of an anastomosis device including a fixing mechanism according to one embodiment, and B is a side perspective view of a first coupler element to which the fixing mechanism can be fixed, according to one embodiment. [Figure 13] A is a side view of a part of an anastomosis device including a fixation mechanism according to one embodiment, and B is a side perspective view of a first coupler element that can be fixed by the fixation mechanism according to one embodiment. [Figure 14A] It is a side view of a part of an anastomosis device including a release mechanism in a first configuration according to one embodiment. [Figure 14B] It is a side view of a part of an anastomosis device in which the release mechanism is in a second configuration according to one embodiment. [Figure 15] It is a schematic flowchart of a method for connecting a first blood vessel to a second blood vessel using an anastomosis device according to one embodiment. [Figure 16] It is a schematic flowchart of a method for connecting a first blood vessel to a second blood vessel using an anastomosis device according to one embodiment. [Figure 17] It is a schematic diagram of various steps of a method for connecting a first blood vessel to a second blood vessel using an anastomosis device according to one embodiment.

[0011] The accompanying drawings are referred to throughout the following detailed description. In the drawings, like reference numerals typically identify like components unless the context indicates otherwise. The exemplary implementations described in the detailed description, the drawings, and the claims are not meant to be limiting. Other implementations may be utilized and other changes may be made without departing from the spirit or scope of the subject matter presented herein. The aspects of the present disclosure described comprehensively herein and shown in the figures can be arranged, substituted, combined, and designed in a variety of different configurations, all of which are explicitly contemplated herein and will be readily understood to form part of the present disclosure.

Embodiments for Carrying Out the Invention

[0012] The embodiments described herein relate to microsurgical instruments, minimally invasive surgery, and laparoscopic surgical devices. More specifically, the embodiments described herein relate to systems, methods, and devices for performing anastomoses of tubular structures via a minimally invasive or laparoscopic surgical approach. The embodiments described herein additionally relate to laparoscopic systems, methods, and devices intended to be used in conjunction with joinable rings or other anastomosis couplers used in microvascular anastomosis to facilitate end-to-end joining of vascular structures (such as arteries and / or veins).

[0013] An anastomosis is a connection between two lumen structures. Generally, an anastomosis connection is surgically formed on a blood vessel (such as a vein or artery) or a tubular gastrointestinal structure (such as the intestine). Conventional techniques allow the anastomosis to be completed between two ends (referred to as end-to-end anastomosis) or between the end of one structure and the side of another structure (referred to as end-to-side anastomosis). Procedures that require these anastomoses are performed thousands of times a day worldwide. Similarly, in multiple surgical specialties, forming reliable non-obstructed anastomoses is relied upon to successfully treat each of their respective patients. Surgical reattachment of veins helps to restore blood circulation, which in turn improves the supply of oxygen and other nutrients to downstream tissues and the return of deoxygenated blood from the tissue to the circulatory system. It is desirable to perform various vascular anastomosis procedures using minimally invasive procedures and with reduced complexity.

[0014] The first technique for performing anastomosis was created by Alexis Carrel, who was later awarded the Nobel Prize in 1912 for his pioneering work. Despite 110 years of surgical advancements and innovations since the development of microsurgical anastomosis, the majority of vascular anastomoses to date still employ suturing techniques similar to Carrel's initial description in the early 1900s. In the 1970s, gastrointestinal stapling devices were introduced, which rapidly replaced the earlier suturing techniques for intestinal anastomoses. However, most surgeons still employ circumferential suturing techniques in the serosal layer above the stapled anastomosis to add support. While generally successful, these techniques can be time-consuming, often require additional surgical expertise, and, if not performed correctly, can result in leakage (blood, fecal contents, gastric contents, lymph, etc.), contraction, stenosis, and / or occlusion at the anastomosis site. In vascular anastomoses, stenosis and / or occlusion can lead to serious complications such as heart attack, stroke, peripheral limb ischemia, amputation, death, and reconstructive failure and soft tissue loss.

[0015] Given the recognized importance of reliable open anastomoses, microvascular anastomosis couplers can offer an excellent alternative to sutures and staples. A microvascular anastomosis coupler can consist of two coupler circular rings, each having a tissue engagement surface containing numerous sharp spikes. The vessel is moved through the center of each ring, and the vessel wall is turned over or wrapped around the tissue spikes for fixation. This is completed at each vessel end, and then the two rings are brought together, with the spikes / pins being pushed into the opposite ring to join the ends together.

[0016] Microvascular anastomosis of blood vessels can be achieved using anastomotic coupling devices such as the GEM(trademark) FLOW COUPLER device. However, current anastomotic couplers are not designed for use in minimally invasive procedures such as laparoscopy or microsurgery, or are not easily adaptable, due to poor visibility, limited surgical space, and the lack of a device for applying two anastomotic couplers together that can be introduced through the small diameter of a trocar port.

[0017] Due to the lack of reliable devices or techniques for applying anastomotic couplers laparoscopically, manual suturing is overwhelmingly used for surgical vascular joining in minimally invasive procedures. Manual suturing of vessels can be extremely difficult, mainly due to the small size of the vessels and the limited working space. Since most vessels are only 1mm to 8mm in diameter, this procedure generally involves the use of a surgical microscope. The sutures are approximately 70μm thick and can be difficult to handle. As a result, surgeons and surgical residents must undergo extensive additional training before performing surgery on patients requiring tissue transplantation. Furthermore, surgeons attempt to limit the pathological condition of the recipient site, resulting in small incisions and small areas to work within. For example, in breast reconstruction after mastectomy using microsurgery, surgeons typically work in a surgical field of 2.5cm to 3cm. These size constraints make it difficult for surgeons to manipulate their surgical instruments. Arterial anastomosis performed by manual suturing takes approximately 23.5 minutes in the operating room, which is undesirable.

[0018] In contrast, embodiments of the anastomotic apparatus and method of use described herein enable, for example, 1) minimally invasive laparoscopic surgery to perform anastomosis of two tubular tissues, such as blood vessels and nerves, through a small incision having a diameter of less than about 25 mm; 2) enable anastomosis of two blood vessels in a time of about 5 minutes or less by simply clamping coupler elements via an end effector including a pair of end effector elements configured to separate or close and connect the coupler elements; and 4) provide surgical freedom by enabling articulation of the end effector around the longitudinal axis. The device may offer one or more advantages, including: 5) providing an elongated body to which an end-effector is attached, which may be more than 8 inches in length, allowing insertion through an incision in the abdominal wall while still allowing anastomosis of blood vessels within the patient's pelvic floor; 6) providing a multifunctional interface that allows all anastomosis-related surgeries to be performed from the interface, thus reducing the use of manual procedures with forceps; and 7) providing significant clinical applicability, usefulness, and novelty in various surgical procedures for the treatment of numerous pathophysiological abnormalities, urinary tract conditions, chronic diseases, and clinical indications, including but not limited to varicocele repair, cardiovascular surgery, varicocele, erectile dysfunction, testosterone deficiency, infertility, nutcracker syndrome, benign prostate hyperplasia (BPH), bladder cancer, prostate cancer, pelvic congestion, ovarian cancer, polycystic ovary syndrome, endometritis, and / or uterine fibroids.

[0019] Various embodiments of systems, methods, and devices that make anastomoses easier and more time-efficient by enabling the use of anastomotic couplers in microsurgery and laparoscopy are disclosed herein. Simplifying anastomotic procedures helps minimize the required operator skill, reduce the duration of extreme concentration, and alleviate surgeon fatigue during long and complex surgical procedures.

[0020] This disclosure and accompanying drawings are intended to illustrate some, but not all, examples or embodiments and are not intended to limit the scope of this disclosure. Any drawings referenced herein may not be to scale and may be exaggerated for illustrative purposes. In the description of some different examples of embodiments below, corresponding features are given the same reference numerals.

[0021] To clarify the disclosure, the terms “proximal” and “distal” are defined herein in relation to the human or robotic operator of the surgical instrument. The term “proximal” refers to the location of an element that is closer to the human or robotic operator of the surgical instrument and further away from the surgical end effector of the surgical instrument. The term “distal” refers to the location of an element that is closer to the surgical end effector of the surgical instrument and further away from the human or robotic operator of the surgical instrument. In addition, the terms “upper,” “lower,” “lateral,” “transverse,” “bottom,” and “top” are relative terms to provide additional clarity to the description of the figures provided below. Thus, the terms “upper,” “lower,” “lateral,” “transverse,” “bottom,” and “top” are not intended to unnecessarily limit the invention as described herein.

[0022] In general, the present disclosure relates to several systems, methods, and devices for applying anastomotic couplers to perform minimally invasive vascular procedures, particularly for performing anastomoses between hollow tissue structures when access to the tissue site is limited. In some embodiments, the device (which may also be referred to herein as anastomotic device, apparatus, or surgical instrument for brevity) is configured to apply anastomotic coupler via a laparoscopic approach and comprises a proximal handle portion or interface, an intermediate shaft assembly of a body extending distally from the handle portion, and an end effector positioned at the distal end of the shaft assembly.

[0023] For example, Figure 1A is a schematic diagram of an anastomosis device 100 for performing laparoscopic anastomosis of a first vessel V1 to a second vessel V2, and Figure 1B is a schematic diagram of a portion of the device 100 of Figure 1A, showing the first vessel V1 and the second vessel V2 coupled to each other via the device 100 of Figure 1A, according to one embodiment. The device 100 includes a body 102 coupled to an interface 104 which may include one or more actuators 106 contained internally or otherwise coupled, and an end effector 120 including a first end effector element 122a configured to removably receive a first coupler element 130a of a coupler 130, and a second end effector element 122b configured to removably receive a second coupler element 130b of a coupler 130. The device 100 may also optionally include an actuation mechanism 140, a locking mechanism 105, and / or a release mechanism 107.

[0024] The body 102 may include an elongated member having a length encompassing all sub-ranges and values ​​in the range of 4 inches to 30 inches (e.g., comprehensively, 4, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 25, 28, or 30 inches). In some embodiments, the body 102 may have a length of at least 8 inches. The body 102 may be formed from any suitable material, such as stainless steel, an alloy, etc. The body 102 may define a longitudinal channel through which various components of the device 100 may be disposed. In some embodiments, a sheath 10 may be disposed around the body 102. The sheath 10 may be formed from any suitable material, such as stainless steel, an alloy, or a plastic. The user may be able to selectively move the body 102 axially within the sheath 102, for example, to extend an end effector or to retract at least partially into the sheath 10.

[0025] The proximal end of the main body 102 is connected to the interface 104, so that an elongated main body extends longitudinally from the interface 104. The interface 104 may include a housing that has an ergonomic shape for user gripping. For example, in some embodiments, the interface 104 may be molded as a handle, or it may include fingers or a handgrip that facilitates the user gripping and manipulating the interface 104 to perform a laparoscopic anastomosis of two blood vessels or any other tubular structure.

[0026] One or more actuators 106 may be coupled to the interface 104. In some embodiments, the actuators 106 may include push buttons, pull levers, triggers structured to be engaged by the user's index and / or middle fingers, thumb triggers configured to be engaged by the user's thumb or operated in other ways, slide actuators, clips, levers, rotary knobs, scissor levers, or other primary levels, any other suitable actuators, and / or combinations thereof. In some embodiments, the device 100 may also include an actuation mechanism 140 extending through one or more channels defined through the body 102, which operably couples the actuators 106 to the end effector 120, for example, causing a corresponding movement or motion of the end effector 120. Such an actuation mechanism 140 may include, for example, rods, gears, rack and pinion, pistons, levers, bands, threads, ropes, pulleys, and the like.

[0027] For example, one or more actuators 106 may be configured to articulate the first end effector element 122a and the second end effector element 122b in one or more directions around the distal end of the main body 102, separating them from each other and / or bringing them closer together. For example, one or more actuators 106 may be configured to move the first end effector element 122a and the second end effector element 122b between a first configuration in which the two end effector elements 122a and 122b are separated from each other, and a second configuration in which the two end effector elements 122a and 122b are adjacent to each other. In the second configuration, the two end effector elements 122a and 122b can be configured to connect the first coupler element 130a to the second coupler element 130b. In some embodiments, the first and second end effector elements 122a, 122b can also be configured to be in an intermediate configuration between, for example, a first configuration and a second configuration. One or more actuators 106 can be coupled to an actuation mechanism 107, which is driven by one or more actuators 106 and can cause movement of the first and second end effector elements 122a, 122b. In some embodiments, the actuator 106 may be configured to articulate one or more parts of the end effector 120 (e.g., the first end effector element 122a and / or the second end effector element 122b) in a single direction (e.g., a first direction), while in other embodiments, the actuator 106 may be configured to articulate one or more parts of the end effector 120 in multiple directions (e.g., a first direction and a second direction). For example, the first direction may involve rotation of the distal ends of the first and second end effector elements 122a / b so that they move toward or away from each other around the distal end of the main body 102, as indicated by arrow A in Figure 1B.Additionally or alternatively, the second direction may include joint articulation of the first and second end effectors 122a / b in a direction substantially perpendicular to the first direction, as indicated by arrow B in Figure 1B, thus allowing degrees of freedom when positioning the end effector 120 at a desired location within the patient P's body. In some embodiments, the first actuator 106 may be configured to rotate the first end effector element 122a about a first axis in order 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 in order to move the second end effector element 122b toward or away from the first end effector element 122a. In some embodiments, the first axis around which the first end effector element 122a rotates and the second axis around which the second end effector element 122b rotates may be the same axis, but in other embodiments, the two axes may be offset from each other. In some embodiments, the first and second end effector elements 122a, 122b may also be pivoted around a third axis or angled away from the longitudinal axis of the body to position the first and second end effector elements 122a, 122b for easier viewing by a user (e.g., a surgeon).

[0028] For example, in some embodiments, movement in the first direction may include articulation of the first and / or second end effector elements 122a / b in a plane extending along the longitudinal axis of the end effector 120, and movement in the second direction may involve articulation of the first and second end effector elements 122a / b about the plane extending along the longitudinal axis.

[0029] As shown in Figures 1A and 1B, 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 defining a first receptacle structured to hold a first coupler element 130a of the coupler 130, and a second end effector element 122b defining a second receptacle structured to hold a second coupler element 130b of the coupler 130. The coupler 130 may include any suitable coupler that can be used to connect two blood vessels or any other tubular tissue structure. For example, the first coupler element 130a may include a ring-shaped member defining a central opening configured to receive the axial end of a first blood vessel V1. Similarly, the second coupler element 130b may also include a ring-shaped member configured to receive the axial end of a second blood vessel V2. In some embodiments, the second coupler element 130b may be a mirror image of the first coupler element 130a.

[0030] In some embodiments, each of the first and second coupler elements 130a / b may include coupling features, such as mating snap-fit ​​features (e.g., pins, grooves, slots, ledges, protrusions, notches, recesses, stoppers, etc.), such that when the corresponding surfaces of the first and second coupler elements 130a / b are pressed against each other, the first coupler element 130a is coupled to the second coupler element 130b. This also brings the corresponding axial ends of the first vessel V1 and the second vessel V2 into contact with each other, which may lead to coupling the vessels V1 and V2 together. In some embodiments, the axial ends of the first and second vessels V1 and V2 may be flared before coupling them together.

[0031] In some embodiments, the first end effector element 122a and the second end effector element 122b can be implemented as jaws or clamping arms that can articulate around their proximal ends, thereby allowing the proximal ends of the first and second end effector elements 122a / b to remain close to each other during operation, while the distal ends of the first and second end effector elements 122a / b can be selectively moved 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 the corresponding portion of the second end effector element 122b (e.g., its corresponding distal end), thereby separating the first coupler element 130a from the second coupler element 130b, and a second configuration in which at least a portion of the first end effector element 122a is in close proximity to the corresponding portion of the second end effector element 122b, thereby coupling the first coupler element 130a to the second coupler element 130b (e.g., as shown in Figure 1B) to connect the first vessel V1 to the second vessel V2.

[0032] In some embodiments, the first and second end effector elements 122a / b may be spaced laterally apart by a constant or variable distance along their length in the first configuration. The first end effector element 122a and / or the second end effector element 122b may then be displaced laterally toward each other until the first and second coupler elements 130a / b are coupled together in the second configuration. The lateral displacement may be lateral translation.

[0033] In some embodiments, the proximal ends of the first end effector element 122a and the second end effector element 122b may be coupled to the distal end of the elongated body 102. The first coupler element 130a and the second coupler element 130b may be detachably coupled to the corresponding distal ends of the first end effector element 122a and the second end effector element 122b, respectively. Furthermore, the first and second end effector elements 122a / b may be configured to articulate around the distal end of the elongated body 102 (for example, in the first direction as indicated by arrow A) in order to move the end effector 120 between the first and second configurations. 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 can be structured to allow the articulation of the first and second effector elements 122a / b as described above.

[0034] 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 of the first end-effector element 122a (e.g., its distal end) is positioned close to the corresponding portion of the second end-effector element 122b, but with a gap between them so that the first coupler element 130a does not connect to the second coupler element 130b. This advantageously reduces the width of the end-effector 120, facilitating insertion into the patient P's body through a small incision (e.g., having a diameter of less than 25 mm), and thus potentially reducing injury and enabling faster healing.

[0035] Any suitable actuation mechanism 140 can be used. In some embodiments, the actuation mechanism 140 may include a first linkage arm coupled to a first end effector element 122a and a second linkage arm coupled to a second end effector element 122b. Each of the first and second linkage arms may include a central hinge, which articulates the first and second linkage arms away from each other around their respective central hinges, so that moving the proximal end of each of the first and second linkage arms closer to the corresponding distal end of the first and second linkage arms selectively moves the end effector from a first configuration to a second configuration. In other words, the first and second linkage arms may function as scissor arms that move the first and second end effector elements 122a / b between a first configuration and a second configuration.

[0036] In some embodiments, the actuation mechanism 140 may include at least one pulley coupled to the corresponding 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. At least one tether may be configured to be displaced longitudinally (for example, by a user via engagement of the corresponding actuator 106). Since the tether extends around the pulley, displacing the tether causes at least one pulley to rotate, moving the end effector between the first and second configurations.

[0037] In some embodiments, the actuation mechanism 140 may include at least one rod coupled to the corresponding one of the first end effector element 122a or the second end effector element 122b, and configured to rotate in order to move the end effector 120 between the first and second configurations. For example, at least one rod may be coupled to the corresponding one of the first end effector element 122a and / or the second end effector element 122b, in close proximity to the radially outer edge of the corresponding one of the first end effector element 122a and the second end effector element 122b. Thus, rotating the rod moves the radially outer edges of the first and second end effector elements 122a / b, located distal to the axial end of the rod, closer to or further away from each other, and thus moves the end effector 120 between the first and second configurations.

[0038] 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 the inner surface of the distal end of the sheath 10 covers or surrounds the respective outer surfaces of the first and second end effector elements 122a / b. In some embodiments, the sheath 10 may have a diameter less than or approximately equal to the maximum width of the end effector 120 such that the axial displacement of the sheath 10 toward the end effector 120 (or the retraction of the end effector 120 within the sheath 10) pushes the first and second end effector elements 122a / b into a second configuration.

[0039] In some embodiments, at least one closure element may be coupled to the first end effector element 122a and the second end effector element 122b and configured to push the end effector toward the second configuration. The closure element may include, for example, a mechanical linkage, rope wire, thread, suture, filament, extruded product, spring, rubber band, bungee cord, any other suitable closure element, or any combination thereof. The closure element may be configured to bias the first end effector element 122a and the second end effector element 122b toward each other in order to facilitate the movement of 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 elastic element may include biasing members such as springs, elastic plates (e.g., NITNOL plates), mechanical linkages, rope wires, threads, sutures, filaments, and extruded products, and may be configured to bias the first and / or second end effector elements 122a / b toward the first configuration.

[0040] In some embodiments, each of the first end-effector element 122a and the second end-effector element 122b may be configured to twist and bend along their respective axes in order to move between the first and second configurations. For example, each of the first and second end-effector elements 122a / b may include an actuation backbone, which may be in the shape of a continuum structure having helical tendon wire routing. Such a structure may include a set of disks through which push-pull tendon wires are routed according to a helical shape around the main axis of the structure. In other embodiments, the backbone may be mesh-like. The actuation mechanism 140 may be configured to engage with the tendon wire such that each backbone of the first and second end effector elements 122a / b is subjected not only to pure rotation but also torsion along the backbone's main axis, causing at least the distal ends of the first and second end effector elements 122a / b to move away from each other, thereby moving the end effector 120 to the first configuration, or causing the first and second end effector elements 122a / b to move toward each other, thereby moving the end effector 120 to the second configuration. Such complex movements can not only separate the distal ends of the first and second end effector elements 122a / b by bending them away from each other, but can also expose the inner surfaces and ultimately the first and second coupler elements 130a / b coupled thereto by rotating the first and second end effectors around their respective longitudinal axes.

[0041] In some embodiments, each of the first end effector element 122a and the second end effector element 122b may include alignment features defined on their corresponding surfaces. The alignment features may be configured to align the first and second end effector elements 122a / b as the end effector 120 moves to the second configuration, for example, to facilitate the alignment of the first coupler element 130a and the second coupler element 130b. Such alignment features may include, but are not limited to, one or more notches, lips, grooves, recesses, stoppers, protrusions, or other mating features that are useful for rough and fine alignment of the first coupler element 130a and the second coupler element 130b during the operation of the device 100 for moving the end effector 120 from the first configuration to the second configuration. Furthermore, the end effector 120 may include one or more grips, grooves, surface modifiers, latching mechanisms, or any combination thereof to facilitate controlled anastomosis.

[0042] Optionally, in some embodiments, the device 100 may include a fixing mechanism 105 that can be configured to selectively fix the coupler 130 (e.g., a first coupler element 130a and / or a second coupler element 130b) to the end effector 122. Optionally, in some embodiments, the device 100 may include a release mechanism 107 for releasing, for example, the first coupler element 130a and / or the second coupler element 130b from the end effector 120. In some embodiments, the receptacles of the first and second end effector elements 122a / b may include notches, cavities, slots, etc., of a shape and size that tightly receive the first and second coupler elements 130a / b, respectively (e.g., via friction fit). In some embodiments, the first and second coupler elements 130a / b may be selectively fixed within or released from their respective receptacles, for example, via a fixing mechanism 105 and / or a release mechanism 107. For example, the release mechanism 107 may be configured to be selectively actuated to release the coupler 130 from the end effector 120 in a second configuration. In some embodiments, the release mechanism 107 may be coupled to the fixing mechanism 105, for example, so that movement of the fixing mechanism 105 drives movement of the release mechanism 107 to release the coupler 130. Alternatively, the device 100 may not include a fixing mechanism 105 or a release mechanism 107. In such a case, the surgeon can disengage the coupler elements 130a / b from the end effector elements 122a / 122b using a separate tool (e.g., pliers, hook, etc.).

[0043] Any suitable fixing mechanism 105 can be used. In some embodiments, at least one of the first coupler element 130a and the second coupler element 130b may have a circumferential groove defined on its radially outer surface, for example, at its radial edge, around the first and / or second coupler element 130a / b. In such embodiments, the fixing mechanism 105 may include a string (e.g., twisted yarn, rope, thread, band, chain, etc.) disposed in part of the circumferential groove to fix the first coupler element 130a and / or the second coupler element 130b within the end effector 120 in the first configuration. The string may be configured to be selectively removed from the circumferential groove by a user (e.g., by engaging the string with a corresponding actuator 106 and pulling it out of the circumferential groove) to release the first coupler element 130a and / or the second coupler element 130b in the first or second configuration. For example, since the first and second coupler elements 130a / b can be joined to each other in the second configuration, releasing one may cause both coupler elements 130a / b to be released.

[0044] In some embodiments, at least one of the first coupler element 122a and the second coupler element 122b has a recess defined on its radially outer surface (for example, on the radially outer edge of the first coupler element 130a and / or the second coupler element 130b). In such embodiments, the fixing mechanism 105 may include a rod having its axial end disposed within the recess for fixing at least one of the first coupler element 130a and the second coupler element 130b to the first configuration (for example, to prevent rotation of the first coupler element 130a and / or the second coupler element 130b within the receptacle, or to snap into the recess to prevent axial displacement of the first and / or second coupler element 130a / b). The axial end of the rod may be configured to be selectively removed from the recess (for example, by a user engaging with an actuator 106 operably coupled to the locking mechanism 105) in order to release the first coupler element 130a and / or the second coupler element 130b in the second configuration. In some embodiments, a biasing member (e.g., a spring such as a coil spring, torsion spring, or disc spring) may be coupled to the rod and configured to bias the rod toward at least one of the first coupler element 130a and the second coupler element 130b, thereby locking them within their respective receptacles.

[0045] In some embodiments, the device 100 may include a release mechanism 107 configured to selectively push the first coupler element 130a and / or the second coupler element 130b out of the end effector 120. For example, the first and second coupler elements 130a / b may be fixed via friction fittings within their respective receptacles of the first end effector element 122a and the second end effector 122b, thereby requiring a predetermined amount of force to discharge the first and second coupler elements 130a / b from their respective receptacles.

[0046] In some embodiments, the release mechanism 107 may include a piston disposed on a portion of the first end-effector element 122a or the second end-effector element 122b. The piston may be configured to selectively protrude into the receptacles of the first end-effector element 122a and / or the second end-effector element 122b (for example, in response to a user engaging the corresponding actuator 106) to push (e.g., push) the first coupler element 130a and / or the second coupler element 130b out of the end-effector 120. For example, as described above, once the first coupler element 130a and the second coupler element 130b are coupled to each other in a second configuration of the end-effector 120 to couple the first vessel V1 to the second vessel V2, the user can engage the corresponding actuator 106 to push the piston into the receptacle. The piston extends axially within the receptacle until the first and second coupler elements 130a / b are released from their respective receptacles. The first and second coupler elements 130a / b can remain inside the patient P's body, but the elongated body 102, and therefore the end effector 120, is withdrawn from the patient P's body.

[0047] The first vessel V1 and the second vessel V2 may be positioned in any part of the patient's body so that the device 100 may be equally applicable when performing a variety of laparoscopic anastomotic procedures, including but not limited to varicocele repair, cardiovascular surgery, erectile dysfunction, testosterone deficiency, infertility, nutcracker syndrome, BPH, bladder cancer, prostate cancer, pelvic congestion, ovarian cancer, polycystic ovary syndrome, endometritis, and / or uterine fibroids. Thus, the device 100 or any other anastomotic device described herein makes anastomosis easier and more time-efficient by enabling the use of anastomotic couplers in microsurgery and laparoscopy. Simplifying anastomotic procedures helps minimize the training of the required operator skills, reduce the duration of extreme concentration, and reduce surgeon fatigue during long and complex surgical procedures.

[0048] The apparatus 100 described herein, or any other anastomotic procedure, may be particularly beneficial when treating the following conditions:

[0049] Varicocele repair: Varicocele is a chronic condition in which the testicular veins enlarge due to the accumulation of venous blood, causing venous reflux and significantly reducing testicular blood flow. The method of treating varicocele is called varicocele excision. Since 1929, the most common method of varicocele excision has focused solely on ligating the testicular veins and preventing reflux.

[0050] The left internal spermatic vein (ISV) merges with the left renal vein at a right angle near the superior mesenteric artery, while the right internal spermatic vein tends to merge with the inferior vena cava at a more acute angle. A one-way valve within the internal spermatic vein (ISV) prevents the backflow of venous blood flowing from the testicles. Venous blood from the testicles must flow upward against gravity, which is the greatest force when standing. The left internal spermatic vein (ISV) merges with the left renal vein at a right angle near the superior mesenteric artery, while the right internal spermatic vein tends to merge with the inferior vena cava at a more acute angle. Repetitive loading of the one-way valve within the ISV (a result of bipedalism or upright posture in humans) often leads to progressive deterioration and eventual failure of the valve.

[0051] This chronic reduction in blood flow can lead to a pathophysiological condition called varicocele. Varicocele is associated with left ISV in 95% of cases. This is a result of various anatomical differences, particularly in vascular length. In fact, left ISV is easier to diagnose and is widely associated with male infertility. Varicocele can also be caused by compression of the renal vein by the superior mesenteric artery and aorta. This leads to the nutcracker phenomenon (NCP) or left renal vein capture. The prevalence of varicocele has been shown to increase with age, reaching over 75% by age 70. Several studies have demonstrated a strong correlation between varicocele and left renal vein compression, as well as deterioration of the unidirectional valve leading to bilateral vascular disease.

[0052] Currently, varicoceles are treated by ligation through several different access points. ISVs are ligated through incisional surgical procedures (microsurgery / surgical ligation through inguinal access, subinguinal access), laparoscopic procedures through abdominal access points, or interventions / percutaneous procedures through femoral vein or carotid artery access points. In a typical laparoscopic varicocele ligation procedure, a camera and several small instruments are introduced into the abdomen. The peritoneum is incised to access the spermatic vein. The ISV is carefully isolated from the artery and lymphatic vessel. The ISV is ligated, clipped, and the tools are withdrawn. In contrast, varicocele repair may be performed via a minimally invasive procedure in less than 5 minutes using device 100, which allows for shorter hospital stays and faster healing times.

[0053] There are several advantages to using fluid connections to treat varicocele, including, for example, a single connection can be made to the entire bed of testicular veins to equalize testicular venous blood pressure, typically including its side branches; this approach can be used in patients with nutcracker syndrome or left renal vein compression, as it allows an alternative route for renal venous blood drainage separate from the renal vein; and it avoids the need for multiple embolic coils to ensure complete occlusion of the spermatic vein. The use of fluid connections also reduces the prostate's exposure to free testosterone compared to embolization or ligation of the testicular veins. The testicular veins are the primary route for draining testicular venous blood. Ligation or occlusion of the testicular veins forces blood drainage into the iliac veins via other smaller vessels. Because the back pressure of testicular venous blood is reduced after ligation or occlusion of the testicular veins, the prostate's exposure to testosterone-rich venous blood is reduced for patients undergoing this treatment. However, ligation or occlusion still exposes the prostate to hyperphysiological levels of testosterone concentration that are higher than normal. Conversely, according to the embodiments described herein, forming a fluid connection using apparatus 100 or any other apparatus described herein allows for the direct drainage of most of the testosterone-rich blood into larger venous vessels, thereby reducing the prostate's exposure to testosterone-rich blood. While the use of a fluid connection may also lead to immediate and long-term pain relief, inflammation of the spermatic cord and testicular veins may recur after occlusion or ligation, as the testicular veins and their collateral branches further deteriorate over time.

[0054] Tissue transplantation: The transplantation of tissue from one part of a patient's body to another provides a means for reconstructive surgeons to repair and replace body parts, restoring appearance, and often function and sensation. The most common reasons patients undergo tissue transplantation are to restore lost function associated with tumor removal (e.g., breast cancer reconstruction), trauma, burns, or birth defects. In these tissue transplants, a microsurgical specialist removes tissue, including skin, fat, muscle, nerves, and bone, along with associated vascular peduncles, from one part of the body and moves it to the part of the body required for aesthetic or functional restoration. Arteries and veins are reattached, and in some cases, nerves are also reattached. Apparatus 100 can be readily applied to tissue transplantation procedures to rapidly and minimally invasively reconnect arteries, veins, and / or nerves.

[0055] Cardiovascular surgery: One of the most common surgical procedures performed today that requires the implementation of anastomosis is coronary artery bypass grafting (CABG), commonly known as bypass surgery. This procedure is used to treat patients with coronary artery disease in the form of one or more coronary arteries that are partially or completely blocked by stenosis. When blood flow through the coronary arteries is restricted or blocked, the myocardial tissue is deprived of sufficient blood flow, which ultimately leads to the death of muscle tissue. Other interventions, such as angioplasty and atherectomy, are also used to treat blocked coronary arteries. However, bypass surgery is usually preferred or necessary to treat patients with severe or multiple coronary artery occlusions, or when other interventions have been unsuccessful or are likely to be unsuccessful.

[0056] To bypass occlusion in the coronary arteries, the surgeon must anastomose a vascular conduit communicating with an arterial blood supply source to the coronary artery downstream of the occlusion. The vascular conduit may be an innate artery carrying blood from the patient's heart, such as the right or left internal mammary artery (IMA). In such cases, the artery may be resected from the patient's body and provide a free end prepared for distal anastomosis to the coronary artery. Alternatively, the IMA may be resected and removed from the body, with one end prepared for anastomosis to an arterial blood source and the other end prepared for anastomosis to a coronary artery. Furthermore, depending on the number of coronary arteries being occluded, other vascular conduits may be required in addition to using the right and / or left IMA. One end of each conduit is prepared for distal anastomosis to the coronary artery, while the other end is prepared for proximal anastomosis to an arterial blood source, such as the aorta. Vascular conduits may be taken from the patient's body, and preferred examples include the left or right IMA, inferior epigastric artery, splenic artery, subclavian artery, and saphenous vein. Animal or synthetic vascular conduits may also be used in place of or in addition to those described above.

[0057] The most common form of bypass surgery involves bypassing occlusions in multiple coronary arteries, such as quadrilateral, quintulateral, or hexalateral bypass procedures. Consequently, most bypass procedures require numerous vascular conduits to form the necessary anastomoses. However, the number of available natural arterial conduits that can be used by simply attaching one end to the occluded coronary artery is limited. Therefore, it is usually necessary to use free conduits or grafts, which require forming anastomoses at both ends of each conduit, with one end to an arterial blood source and the other end to the occluded coronary artery. The patient's aorta is the preferred arterial blood source to which the proximal ends of one or more conduits can be anastomosed. As with all other anastomoses, the surgeon must tightly suture the proximal end of each conduit to the patient's aorta to obtain a strong, fluid-tight connection, which is a highly technical and time-consuming procedure. Nevertheless, when bypass surgery is performed via a conventional thoracotomy in which the patient's sternum is split and retracted, the surgeon has essentially unhindered access to the heart and aorta, which reduces the difficulty of forming proximal anastomoses between the vascular conduits and the patient's aorta.

[0058] However, in recent years, there has been a shift from open-chest surgery to minimally invasive cardiac surgery. These procedures are typically performed through incisions made between the ribs, which requires surgeons to operate with significantly less access to the heart and aorta compared to open-chest procedures. This reduced access to the heart increases the difficulty and time associated with performing vascular anastomoses. When surgeons operate through small incisions or trocar ports, already highly technical procedures become even more difficult. Devices and methods used in conventional open-chest cardiac surgery are not always available or readily adaptable for performing minimally invasive cardiac surgery. Anastomotic couplers, often used in incisions to join various tissue structures, are not designed for use in minimally invasive cardiac surgery or are not readily adaptable. In contrast, device 100 or any of the anastomotic devices described herein may be used to easily access the heart through small incisions and to rapidly perform vascular anastomoses.

[0059] This disclosure describes several clinical conditions that may benefit from laparoscopic procedures performed by the devices described herein, although device 100 or any of the devices described herein may be used for any clinical or surgical procedure. Examples of such clinical conditions, particularly varicocele, are described in International Application US2020 / 062287, filed November 25, 2020, entitled “Systems, Apparatus, and Methods for Treatment of Varicocele and Associated Conditions,” the entire disclosure of which is incorporated herein by reference.

[0060] Figure 2 is a schematic flowchart of Method 200 for laparoscopically joining a first vessel (e.g., first vessel V1) to a second vessel (e.g., second vessel V2) using an anastomosis device (e.g., anastomosis device 100) according to one embodiment. Although described with respect to device 100, the operation of Method 200 may be implemented using any of the anastomosis devices described herein. All such embodiments should be contemplated and considered to be within the scope of this disclosure.

[0061] Method 200 includes, in 202, ligating a first blood vessel V1 using, for example, a clip, band, clamp, etc. Method 200 also includes, in 204, ligating a second blood vessel V2. In some embodiments, Method 200 may include, in 206, coupling a first coupler element 130a to the receptacle of a first end-effector element 122a and coupling a second coupler element 130b to the receptacle of a second end-effector element 122b. For example, the apparatus 100 may be provided to the user with the coupler 130 separated from the end-effector 120. In other embodiments, the apparatus 100 may be provided with the first and second coupler elements 130a / b already coupled to the first and second end-effector elements 122a / b, respectively, thus eliminating the need for operation 206.

[0062] In 208, the distal end of the device 100 is inserted into the body of patient P. For example, a small incision having a diameter of 25 mm or less may be made in the body of patient P, and the distal end of the elongated body 102, and therefore the end effector 120, may be inserted into the body of patient P. In some embodiments, the end effector 120 may be moved to the intermediate configuration as described above before insertion of the end effector 120 into the body of patient P in order to facilitate insertion.

[0063] At 210, the end effector 120 is moved to an open configuration (i.e., a first configuration). For example, after inserting the end effector 120 into the patient P's body, the user can engage an actuator 106 (e.g., a corresponding one of a set of actuators 106) to articulate the first and second end effector elements 122a / b so that they move away from each other around the distal end of the elongated body.

[0064] In 212, the axial end of the first vessel V1 is connected through the first coupler element 130a. In 214, the axial end of the second vessel V2 is connected through the second coupler element. For example, to connect the first and second vessels V1 and V2 to the first and second coupler elements 130a / b, the axial end of the first vessel V1 may be inserted through a through hole defined through the first coupler element 130a, and the axial end of the second vessel V2 may be inserted through a through hole defined through the second coupler element 130b. In some embodiments, the axial ends of the first vessel V1 and the second vessel V2 may be flared after being inserted through the first and second coupler elements 130a / b, respectively. In some embodiments, pins, protrusions, notches, grooves, or any other fixing elements may be provided on the respective surfaces of the first and second coupler elements 130a / b facing each other. The axial ends of the first and second blood vessels V1 and V2 may be connected to the first and second coupler elements 130a / b, respectively, by coupling their axial ends to a fixed element.

[0065] In 216, the first end-effector element 122a and / or the second end-effector element 122b may be moved to a closed configuration (i.e., the second configuration) to couple the first coupler element 130a to the second coupler element 130b, and thus, as described above, the first vessel V1 is coupled to the second vessel V2. In 218, the first and second coupler elements 130a / b are released from the first and second end-effector elements 122a / b, for example, by releasing the first and / or second coupler elements 130a / b from the fixing mechanism 105 and / or by activating the release mechanism 107, as described above. Alternatively, the surgeon may use a separate tool to pull the first and second coupler elements 130a / b from the first and second end-effector elements 122a / b or otherwise disengage them. In step 220, the device 100 is withdrawn from the patient P's body, for example, by withdrawing the elongated body 102 and, consequently, the end effector 120 from the patient P's body. The end effector 120 may be maintained in a closed configuration while being withdrawn from the patient P's body. The laparoscopic incision is closed to complete the surgical procedure (e.g., sutured, stapled, or bonded).

[0066] Referring to Figures 3 to 4C, Figure 3 is a side perspective view of an anastomosis device 300 with an end effector 320 in a first (open) configuration according to one embodiment, and an enlarged view of the end effector 320. The device 300 may include a handle assembly 301 (e.g., an interface), a shaft assembly 302 extending longitudinally and distally from the handle assembly 301, and an end effector 320 located at the distal end of the shaft assembly 302. The handle assembly 301 may include a body 303, which includes a pistol grip 304 and an anastomosis control button 306a (e.g., a first actuator) configured to be operated by the user to control various aspects of the application of anastomosis coupler rings 330a and 330b (e.g., first and second coupler elements) to target vessels (e.g., vessels V1 and V2), and their release from the end effector 320 of the surgical instruments 300. A trigger 306 (e.g., a second actuator) may be coupled to the lower portion of the body 303 and pivotable toward and away from the pistol grip 304 to selectively actuate the end effector 320. In some embodiments, the handle assembly 301 may include a scissor grip configuration. The body 303 may also be referred to herein as the housing 303 and may include one component or an assembly of components. Accordingly, the terms “body” and “housing” are not intended to unnecessarily limit the embodiments described herein to any number of distinct components.

[0067] As shown in Figure 3, the end effector 320 includes a first clamp arm 322a and a second clamp arm 322b (e.g., first and second end effector elements) configured to pivot selectively toward or toward each other for the purpose of applying or joining together the ends of two tubular structures such as arteries, veins, and / or nerves. Each clamp arm 322a / b may be operably coupled to a trigger 306b such that the set of clamp arms 322a / b is configured to pivot toward each other in a closed position in response to the pivot of the trigger 306b toward the pistol grip 304, for example. Furthermore, the set of clamp arms 322a / b may be configured to pivot away from the closed position to an open position in response to the pivot of the trigger 306b toward the pistol grip 304. Various preferred ways in which the clamp arms 322a / b may be coupled to the trigger 306b will be apparent to those skilled in the art in consideration of this disclosure. In some versions, one or more elastic elements may be incorporated to bias the clamp arms 322a / b and / or trigger 306b toward the open position.

[0068] The shaft assembly 302 of the device 300 may include an outer tube 309 extending along the longitudinal axis, an inner tube 310 disposed through the outer tube 309, and a coupler release rod (not shown) supported within and extending longitudinally through the inner tube 310. The proximal end of each clamp arm 322a / b may be pivotably coupled to the distal end of the outer tube 309 and / or the inner tube 310, allowing the clamp arms 322a / b to pivot relative to the shaft assembly 302 about a pivot axis defined by a pivot pin 311 extending transversely through the distal end of the inner tube 310. In some embodiments, the shaft assembly 302 may alternatively include one or more lumens extending through the shaft assembly 302 to an end effector 320, which may be configured for operational control of the surgical instrument 300 for performing anastomosis, including one or more pusher rods or actuation cables.

[0069] In some embodiments, as shown in Figure 3, the inner tube 310 may be fixed longitudinally to the handle assembly 301, and the outer tube 309 may be configured to translate relative to the inner tube 310 and the handle assembly 301 along the longitudinal axis of the shaft assembly 302. When the outer tube 309 is translated distally, each clamp arm 322a / b may pivot about its pivot axis toward its open position. When the outer tube 309 is translated proximal, each clamp arm may pivot about its pivot axis in the opposite direction toward its closed position. Although not shown, in some embodiments, the proximal end of the outer tube 309 may be operably coupled to a trigger 306b, so that the activation of the trigger 306b causes the outer tube 309 to translate relative to the inner tube 310, thereby opening or closing the set of clamp arms 322a / b as described above. In some embodiments, the outer tube 309 may be fixed longitudinally, and the inner tube 310 may be configured to translate to move the set of clamp arms 322a / b between an open position and a closed position. Various other suitable mechanisms for operating the set of clamp arms 322a / b may be used and should be considered within the scope of this disclosure.

[0070] In some embodiments, the shaft assembly 302 and the end effector 320 may be configured to rotate together with respect to the body 304, deviating from the longitudinal axis defined by the shaft assembly 302. As shown in Figure 3, the shaft assembly 302 may include a rotary knob 312 located at its proximal end and a shaft coupler configured to mechanically connect to the body coupler of the handle assembly 301. The rotary knob 312 may be rotatably coupled to the body 304 of the handle assembly 301, or rotatably fixed to the outer tube 309 and inner tube 310 (for example, by coupling pins extending transversely through them). In other examples, the rotary knob 312 may be rotatably fixed to the remaining components of the shaft assembly 302 in any preferred manner. The rotary knob 312 may be configured to be gripped by an operator to selectively manipulate the rotational orientation of the shaft assembly 302 and the end effector 303 relative to the handle assembly 301.

[0071] Referring to Figures 4A to 4C, Figure 4A is a top perspective view of the end effector 320 of Figure 3 in a first configuration within a patient's body, with a first vessel V1 inserted through a first coupler ring 330a connected to a first clamp arm 322a, and a second vessel V2 inserted through a second coupler ring 330b connected to a second clamp arm 322b. The pair of anastomotic rings 330a / b define through-holes 332a / b into which the first vessel V1 and the second vessel V are inserted, respectively. The first coupler ring 330a is located within the first receptacle 324a of the first clamp arm 322a, and the second coupler ring 330b is located within the second receptacle 324b defined within the second clamp arm 322b. The coupler rings 330a / b are configured to connect the tubular tissue structures V1 and V2 to the clamp arms 322a / b.

[0072] The coupler ring 330a / b may include a plurality of fasteners that are operable to puncture tubular structures and join together to form an anastomosis. In some embodiments, the coupler ring 330a / b may be detachably coupled to the clamp arm 322a / b after the first vessel V1 has been coupled to the second vessel V2, for example, as shown in Figure 4C. Thus, the coupler ring 330a / b may be replaceable to allow for multiple uses of the surgical instrument 300. In some embodiments, the coupler ring 330a / b may not be detachable so that the surgical instrument 300 is provided for single use. The surgical instrument 300 may include a pusher rod operably coupled to an anastomosis control button 306a to controllably release the coupler ring 330a / b from the clamp arm 322a / b.

[0073] Figure 4B is a top perspective view of the end effector 320 in a second configuration in which the clamp arms 322a / b close to connect the first coupler ring 330a to the second coupler ring 330b, thereby connecting the first blood vessel V1 to the second blood vessel V2. Figure 4C shows the device 300 with the first blood vessel V1 connected to the second blood vessel V2, and the coupler rings 330a / b left inside the patient's body, with the device removed from the coupler rings 330a / b.

[0074] Figure 5A shows a partial side perspective view and a side view of the anastomosis device 400 according to one embodiment. Figure 5B shows a partial side perspective view and a side view of the device 400 of Figure 5A in an intermediate configuration, and Figure 5C shows a partial side perspective view and a side view of the device 400 of Figure 5A in a second configuration. The device 400 includes a sheath 401, an operating mechanism 440 including first and second linkage arms 442a and 442b, and an effector 420 including clamp arms 442a and 442b (e.g., first and second end effector elements). The clamp arms 442a / b may be configured to pivot around the operating mechanism 440, which may include an unconventional rotary joint formed by the first and second linkage arms 442a / b. For example, the actuation mechanism 440 may include a first linkage arm 442a coupled to a first clamp arm 422a and a second linkage arm 442b coupled to a second clamp arm 422b. Each of the first and second linkage arms 442a / b may include a central hinge 444a / b. Furthermore, the proximal ends of the clamp arms 422a / b may be coupled to the distal end of the actuation mechanism 440 via a pivot joint 410, thereby causing the first and second linkage arms 442a / b to articulate away from each other around their respective central hinges 444a / b, thereby selectively moving the end effector 420 from an open configuration to a closed configuration by moving the distal end of each of the first and second linkage arms 442a toward the corresponding proximal end of the first and second linkage arms 422a. In some embodiments, the end effector 420 may be at least partially retracted into the sheath 401, as shown in Figure 4C, in order to move the end effector 420 into a closed configuration.

[0075] Conventionally, laparoscopic jaws pivot around a rotary joint perpendicular to the main axis of the apparatus or device. This results in planar motion of the end effector. In contrast, apparatus 400 allows for better visibility, exposure, and access to the inner surface of the clamp arms 422a / b via angled, pivoting linkage arms 442a / b. By determining the desired configuration of the clamp arms 422a / b in closed and open configurations, it may be possible to determine the optimal axis of rotation, and therefore the joint angle relative to the main axis of apparatus 400, so that the clamp arms 422a / b can achieve a three-dimensional (non-planar) trajectory when moving between the open and closed configurations.

[0076] Figure 6A is a partial top view of the anastomosis device 500 in a second (closed) configuration according to one embodiment, and Figure 6B is a side view thereof. Figure 6C is a partial top view of the device 500 in a first (open) configuration, and Figure 6D is a side view thereof. Figure 6E is a schematic diagram of the trajectory of the end effector of the device in Figures 6A to 6D between the first and second configurations. The device 500 includes an end effector 520 including a clamp arm that defines a receptacle 524, the clamp arm being coupled at its proximal end to an elongated body 502 via an actuation mechanism 540. The actuation mechanism 540 may include a pulley 542 coupled to the corresponding one of the first and second clamp arms 520. At least one tether 544 is coupled to a corresponding pulley 542 and is configured to be displaced longitudinally so as to rotate one or both pulleys 542, thereby moving the end effector 520 between a first configuration and a second configuration.

[0077] In some embodiments, any of the anastomosis devices described herein may have dual operating modes, for example, 1) a first operating mode that allows for large movements of the end effector, and 2) a second operating mode that includes fine and rigid closure of the clamp arm (e.g., in the direction indicated by arrow A in Figure 1B). The first operating mode may allow the device to perform its desired task by rapidly (e.g., at a speed exceeding about 180 degrees / second) and easily (e.g., with one degree of freedom) releasing the end effector clamp arm. This can be achieved via any mechanism (e.g., mechanical linkage, nitinol ribbon, wire, rope, etc.). The latter operating mode may allow for the slow and controlled generation of a high clamping force at the tip of the clamp arm. This may be achieved by translating the outermost shaft of the device across jaws designed with a specific interference angle.

[0078] Figure 7A is a front view of a portion of the anastomotic device or surgical instrument 600 in a second (closed) configuration according to one embodiment, Figure 7B is a side perspective view, and Figure 7C is a top view. Figure 7D is a top view of a portion of the device 600 in a first (open) configuration, and Figure 7E is a side perspective view. The device 600 may include a shaft assembly 602 including an end effector 620 with clamp arms 622a / b defining the receptacle 624a / b. The device 600 includes an actuation mechanism 640, which includes a first rod 642a coupled to the first clamp arm 622a and a second rod 642b coupled to the second clamp arm 622b, and is configured to rotate to move the end effector 620 between the first and second configurations. For example, the rods 642a / b may be coupled to the clamp arms 622a / b, respectively, in close proximity to the radially outer edges of the clamp arms 622a / b, as shown in Figures 7A to 7E.

[0079] More specifically, the apparatus 600 may include a handle assembly and a shaft assembly substantially similar to those of surgical instruments 100, 300, including a shaft assembly 602. As shown in Figures 7A to 7E, the end effector 620 includes a set of pivotable clamp arms 622a / b configured to pivot selectively toward or away from each other for the purpose of applying or joining together the ends of two tubular structures, such as arteries and / or veins. Each clamp arm 622a / b may be operably coupled to an actuator (e.g., trigger 306b) such that the set of clamp arms 622a / b is configured to rotate toward a closed position in response to a pivot of the actuator (e.g., moving the trigger 306b toward the pistol grip 304). Furthermore, the set of clamp arms 322a / b may be configured to rotate away from the closed position to an open position in response to the opposite movement of the actuator (e.g., pivoting the trigger 306b away from the pistol grip 304).

[0080] The shaft assembly 602 extends along the longitudinal axis and may include an outer tube (not shown) and an inner tube 610 received within the outer tube, and optionally includes a coupler release rod (not shown) supported within the inner tube 610 and extending longitudinally through it. The proximal end of each clamp arm 622a / b may be rotatably coupled to the distal end of the outer tube and the inner tube 610 via a rod 642a / b, allowing each clamp arm 622a / b to rotate relative to the shaft assembly 602 about a pivot axis defined by a rod 642a / b (e.g., a pivot pin) extending transversely through the distal end of the inner tube 610.

[0081] In some embodiments, the inner tube 610 may be fixed longitudinally to the handle assembly (e.g., handle assembly 301). When the actuator (e.g., trigger 306b) is pulled, each clamp arm 622a / b rotates toward its closed position about a pivot axis defined by the rod 642a / b. When the actuator (e.g., trigger 306b) is released, each clamp arm 622a / b rotates toward its open position about the pivot axis in the opposite direction. Various other suitable mechanisms for operating the set of clamp arms 308 between the open and closed positions may be used and should be considered to be within the scope of this disclosure.

[0082] In some embodiments, the shaft assembly 602 and the end effector 620 may be configured to rotate together with respect to the interface (e.g., body 301) away from the longitudinal axis defined by the shaft assembly 602. The surgical instrument 600 may also include a pair of anastomotic coupler rings (e.g., coupler rings 330a / b) disposed within the receptacle 624a / b and configured to connect tubular tissue structures (e.g., blood vessels V1 and V2) to the clamp arms 622a / b. The connecting rings may include a plurality of fasteners that are operable to puncture the tubular structures and join together to form an anastomosis. In some embodiments, the coupler rings can be detachably coupled to the clamp arms 622a / b. Thus, the coupler rings may be replaceable to allow for multiple uses of the surgical instrument 600. In some embodiments, the coupler rings may not be detachable so that the surgical instrument 600 may be provided for single use. The surgical instrument 600 may include a pusher rod operably coupled to a corresponding actuator (e.g., anastomosis control button 306a) for controllably releasing a coupler ring (e.g., coupler ring 330a / b) from the clamp arm 622a / b.

[0083] In some embodiments, the end effector 600 or any of the end effectors described herein may additionally include one or more closing elements to assist in the complete closing of the coupler ring. In some embodiments, one or more elastic members may be incorporated to bias the clamp arm and / or actuator toward the open position. For example, Figure 8A is a top view of the apparatus 700 according to one embodiment, including an elastic element 725 and a closing element 727, and Figure 8B is a front view thereof. The apparatus 700 includes a shaft assembly 702, an end effector 720 including clamp arms 722a / b defining receptacles 724a / b for receiving the coupler ring, and pivot rods 742a / b coupled to each clamp arm 722a / b. The elastic element 725 may be coupled to each of the clamp arms 722a / b and may include biasing members such as springs, elastic plates (e.g., nitinol plates), mechanical linkages, rope wires, threads, sutures, filaments, extruded products, etc., and may be configured to bias the clamp arms 722a / b toward the open configuration. Furthermore, the closing element 727 may be coupled to each of the clamp arms 722a / b. The closing element 727 may include, for example, mechanical linkages, rope wires, threads, sutures, filaments, extruded products, springs, rubber bands, bungee cords, any other suitable closing elements, or any combination thereof, and may be configured to bias the clamp arms 722a / b toward the closed configuration.

[0084] Figure 9A is a top view of a portion of the anastomosis device 800, including an end effector 820 in a second (closed) configuration according to one embodiment, which includes a first clamp arm 822a and a second clamp arm 822b configured to bend along its longitudinal axis, and Figure 9B is a top view of the device 800 in which the end effector 820 is in the first (open) configuration. The clamp arms 822a / b define receptacles 824a / b configured to removably receive coupler rings (e.g., coupler rings 330a / b). In some embodiments, the clamp arms 822a / b may include working backbones 803, 804, which may be in the shape of a continuum structure having helical tendon routing. Such a structure may include a set of disks 805 through which push-pull tendon wires 806 can be routed according to a helical shape around the main axis of the structure. By pulling the tendon wire, the backbone 803 and / or 804 may experience not only pure rotation but also twisting along the backbone main axis 408. Such complex movements may not only separate the distal ends of the clamp arms 822a / b but also expose their inner surfaces, and ultimately expose the coupler ring, which may be embedded in or otherwise disposed within the receptacle 824a / b.

[0085] Figure 10A is a top view of the anastomosis device 900, including a biasing member in a second (closed) configuration according to one embodiment, and Figure 10B is a side view thereof. Figure 10C is a top view of the device 900 of Figure 10A in a first (open) configuration, and Figure 10D is a side view thereof. The device 900 includes an end effector 920 which includes clamp arms 922a / b defining a receptacle 924a / b configured to removably receive a coupler ring (e.g., coupler ring 330a / b). The clamp arms 922a / b may be provided with independent closure control units 905a and 905b (e.g., rope, string, wire, tether, rod, etc.). Each of the clamp arms 922a / b is coupled to a shaft assembly 902 by a pivot joint 910a / b such that the clamp arms 922a / b open like scissors. In some embodiments, the clamp arms may be equipped with biasing members 904 (e.g., spring-loaded) which may be actuated via closure control units 905a / b to assist in their return to a closed configuration. Such a configuration may allow exposure of the inner lumen 906 (Figure 10B) of a dedicated vascular implant, which is divided into two (906a and 906b as shown in Figure 10D) on both sides of each clamp arm 922a / b.

[0086] Figure 11 is a side view of an end effector 1020 that may be included in an anastomosis device (e.g., devices 100, 300) according to one embodiment. The end effector 1020 includes clamp arms 1022, each defining a receptacle 1024. The clamp arms 1022 may include one or more alignment features 1026 configured to precisely align the clamp arms 1022 during coupler ring joining. The alignment features 1026 may include a plurality of notches, lips and grooves, or other mating features that facilitate coarse and fine alignment of the coupler ring during the operation of associated surgical instruments (e.g., devices 100, 300). The end effector 1020 may additionally or alternatively include one or more grips, grooves, surface modifications, latching mechanisms, or any combination thereof to facilitate controlled anastomosis.

[0087] Figure 12A is a side view of a portion of an anastomosis device 1100 including a fixation mechanism 1105 according to one embodiment, and Figure 12B is a side perspective view of a coupler ring 1130 to which the fixation mechanism 1105 can be fixed, according to one embodiment. The coupler ring 1130 is disposed within a receptacle 1124 of a clamp arm 1122 and defines a dedicated track or groove 1136 on its outer peripheral surface 1133 that enables proper and secure engagement of the fixation mechanism 1105 (e.g., wire, suture, rope, etc.) with the end effector 1122 of a surgical tool. The track 1136 may be friction-fitted to the fixation mechanism 1105 so that when the coupler ring 1130 is ready to deploy, the fixation mechanism 1105 can be released, for example, by pulling from one of its ends. The coupler ring 1130 (or any of the coupler rings described herein) may be formed from any suitable biocompatible material, including but not limited to metals, alloys, plastics, ceramics, polymers, or any combination thereof.

[0088] Figure 13A is a side view of a portion of an anastomosis device 1200 including a fixing mechanism 1205 according to one embodiment, and Figure 13B is a side perspective view of a coupler ring 1230 to which the fixing mechanism 1205 can be fixed, according to one embodiment. The coupler ring 1205 is detachably disposed within a receptacle 1124 of a clamp arm 1122. The coupler ring 1230 defines a dedicated recess 1236 on its circumferential outer surface 1233 which can act as a keyhole. Furthermore, the clamp arm 1222 may include a fixing mechanism 1205 which may include a spring rod or piston that can be engaged by a user to selectively, reliably, and controllably engage / disengage with the coupler ring 1205.

[0089] Figure 14A is a partial side view of an anastomosis device 1300, including a release mechanism 1307 in a first configuration according to one embodiment. Figure 14B is a partial side view of an anastomosis device 1300, in which the release mechanism 1300 is in a second configuration. The device 1300 includes an end effector, which includes a clamp arm 1322 defining a receptacle 1324 in which a coupler ring 1330 is disposed. The release mechanism includes a piston 1309, which may be configured to selectively push the coupler ring 1330 into the receptacle from the clamp arm 1322 in order to discharge it from the receptacle 1324.

[0090] Figure 15 is a schematic flowchart of method 1400 for joining a first blood vessel to a second blood vessel using an anastomosis device, according to one embodiment. In some embodiments, method 1400 includes, in 1402, preparing a first tubular tissue structure for anastomosis. In 1404, a second tubular tissue structure may be prepared for anastomosis. In 1406, surgical instruments (e.g., devices 100, 300 or any other devices described herein) are prepared (e.g., coupler rings 130a / b, 330a / b are loaded and moved to an intermediate position, as described herein).

[0091] In 1408, the surgical instrument is introduced to the surgical site. In 1410, at least a portion of the first tubular tissue structure is advanced or passed through the first distal opening of the first clamp arm of the surgical instrument. In 1412, at least a portion of the second tubular tissue structure is passed through the second distal opening of the second clamp arm of the surgical instrument. In 1414, a change in the configuration of the first and second clamp arms is caused to ensure that the first and second tubular tissue structures are securely joined. In 1416, method 1440 may include causing a change in the configuration of the end effector to separate the first and second tubular tissue structures from the distal side of the surgical instrument. In 1418, the surgical instrument is separated from the target surgical site.

[0092] Figure 16 is a schematic flowchart of method 1500 for anastomosis of a first tubular tissue structure to a second tubular tissue structure according to one embodiment. Method 1500 may include, in 1502, preparing the first and second tubular tissue structures for anastomosis, preparing the surgical instruments, and after introducing the surgical instruments to the target surgical site, passing at least a portion of the first tubular tissue structure through the first coupler ring of the first clamp arm of the surgical instruments. In 1504, passing at least a portion of the second tubular tissue structure through the second coupler ring of the second clamp arm of the surgical instruments. In 1506, causing a change in the configuration of the first and second clamp arms of the surgical instruments to join the first and second coupler rings. After enabling tissue anastomosis, method 1500 may also include, in 1508, separating the first and second tubular tissue structures from the surgical instruments. The surgical instruments may be separated from the target surgical site.

[0093] Figure 17 is a schematic diagram of various operations of Method 1600 for treating BPH according to one embodiment. Method 1600 may include incising tissue to detach a first tubular tissue structure. Ligating the first tubular tissue structure. Incising tissue to detach a second tubular tissue structure. Ligating the second tubular tissue structure. Method 1600 may also include closing at least portions of the first and second tubular tissue structures to prevent blood loss. Introducing surgical instruments into the target surgical site through a tissue access port (such as an incision or laparoscopic trocar).

[0094] Method 1600 may also include causing a change in the configuration of the first and second clamp arms to move the clamp arms into an open configuration. Method 1600 may also include passing at least a portion of the first tubular tissue structure through the first coupler ring of the first clamp arm of the surgical instrument and passing at least a portion of the second tubular tissue structure through the second coupler ring of the second clamp arm of the surgical instrument. Method 1600 may also include fixing at least a portion of the first and second tubular tissue structures to at least a portion of the first and second clamp arms, causing a change in the configuration of the first and second clamp arms to ensure that the first and second tubular tissue structures are joined. A change in the configuration of the end effector of the surgical instrument may be caused to separate the first and second tubular tissue structures from the distal side of the surgical instrument. A change in the configuration of the first and second clamp arms may be caused to move the clamp arms into a closed configuration, and the surgical instrument may be separated from the target surgical site. The first and second tubular tissue structures may be left open to allow fluid flow between them.

[0095] For example, complete closure of any of the clamp arms of the end effectors described herein would be desirable, as incomplete closure can lead to potential leakage, coagulation, and bleeding. The clamp arms must not only mate with each other, but may also have to overcome the frictional forces associated with mating a coupler ring, for example, a ring in which a pin needs to slide into a corresponding hole. The closing force may be increased by adding elements to the end effectors. Such elements may include, for example, a sheath (e.g., sheath 401) which can be used to compress the clamp arms together from the outside. In some embodiments, two clamp arms can be pulled together by using a mechanical linkage or pull wire inside the clamp arms. In some embodiments, preferred elements may include compression using magnets, electromagnets, pneumatic and / or hydraulic means. Additionally or alternatively, the clamp arms may include ultrasonic transducers that help overcome frictional forces when the pin of the coupler ring slides into the corresponding snap-fit ​​channel.

[0096] In some embodiments, any of the end effectors described herein may be configured to articulate around the distal end of the elongated body or shaft assembly by an angle within a range of at least about 20 degrees (e.g., including 20, 40, 60, 80, 90, 100, 110, or 120 degrees). This can increase the visibility of various elements important for performing anastomotic procedures.

[0097] As used herein, the singular forms "a," "an," and "the" include plural references unless the context explicitly indicates otherwise. For example, the term "component" is intended to mean a single component or combination of components, while "material" is intended to mean one or more materials or combinations thereof.

[0098] As used herein, the terms “about” and “approximately” generally mean plus or minus 10% of the stated value. For example, about 0.5 includes 0.45 and 0.55, about 10 includes 9 to 11, and about 1000 includes 900 to 1100.

[0099] As used herein, the terms “substantially” and similar terms are intended to have a broad meaning consistent with the common and acceptable usage of those skilled in the art to which the subject matter of this disclosure relates. For example, the term “substantially flat” means that there may be a small amount of surface variation or undulation present due to manufacturing variations present on an otherwise flat surface. It should be understood by those skilled in the art considering this disclosure that these terms are intended to enable the description and the description of specific features claimed without limiting the scope of these features to the precise arrangement and / or numerical range provided. Accordingly, these terms should be interpreted as indicating that non-substantially or insignificant modifications or alterations of the subject matter described and claimed are considered to fall within the scope of the invention as described in the appended claims.

[0100] It should be noted that the term “exemplary” as used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, presentations, and / or illustrations of possible embodiments (and such term is not intended to imply that such embodiments are necessarily special or best examples).

[0101] As used herein, terms such as “joined” mean joining two members directly or indirectly to one another. Such joining may be fixed (e.g., permanent) or movable (e.g., removable or detachable). Such joining may be achieved by having the two members, or the two members and any additional intermediate members, form a single, integral unit with each other, or by having the two members, or the two members and any additional intermediate members, attached to each other.

[0102] It is important to note that the configurations and arrangements of the various exemplary embodiments are for illustrative purposes only. While only a few embodiments are described in detail in this disclosure, those skilled in the art who are considering this disclosure will readily understand that many modifications are possible (e.g., variations in the size, dimensions, structure, shape and proportions of various elements, parameter values, mounting arrangement, material use, color, orientation, etc.) without substantially departing from the novel teachings and advantages of the subject matter described herein. Other substitutions, modifications, changes, and omissions can also be made in the design, operating conditions, and arrangements of the various exemplary embodiments without departing from the scope of the invention.

[0103] This specification includes details of many specific implementations, but these should not be interpreted as limitations on the scope of any invention or what may be claimed, but rather as descriptions of features specific to a particular implementation of a particular invention. Specific feature components described herein in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various feature components described in the context of a single implementation may be implemented separately or in any preferred secondary combination in multiple implementations. Furthermore, features may be described above as acting in a particular combination, and may even be initially claimed as such; however, one or more features from a claimed combination may, in some cases, be removed from the combination, and the claimed combination may be directed towards a partial combination or a variation of a partial combination.

[0104] The above describes specific implementations of the present invention. Other implementations are within the scope of the following claims. In some examples, the operations described in the claims can be performed in a different order, and the desired results can still be achieved. Furthermore, the processes shown in the accompanying drawings do not necessarily require the specific or sequential order shown to achieve the desired results. In certain implementations, multitasking and parallel processing may be advantageous.

Claims

1. A device comprising an interface, an elongated body connected to the interface and extending longitudinally from the interface, an end effector connected to the distal end of the elongated body, and a sheath disposed around the elongated body, The aforementioned end effector is, A first end effector element defining a first receptacle structured to hold a first coupler element of a coupler, wherein the first coupler element is configured to receive the axial end of a first blood vessel, A second end effector element defining a second receptacle structured to hold a second coupler element of the coupler, wherein the second coupler element is configured to receive the axial end of a second blood vessel, The end effector is configured to move between a first configuration in which at least a portion of the first end effector element is separated from the corresponding portion of the second end effector element, thereby separating the first coupler element from the second coupler element, and a second configuration in which at least the portion of the first end effector element is close to the corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element so as to connect the first vessel to the second vessel. The apparatus is configured such that the sheath is displaced axially toward the end effector so as to push the end effector toward the second configuration.

2. The proximal ends of the first end effector element and the second end effector element are connected to the distal end of the elongated body. The first coupler element and the second coupler element are configured to be detachably coupled to the corresponding distal ends of the first end effector element and the second end effector element, respectively. The apparatus according to claim 1, wherein the first and second end effector elements are configured to articulate in a first direction around the distal end of the elongated body in order to move the end effector between the first configuration and the second configuration.

3. The apparatus according to claim 2, wherein the proximal ends of the first and second end effector elements are coupled to the distal ends of the elongated body via an actuation mechanism structured to allow articulation of the first and second effector elements.

4. The apparatus according to claim 3, wherein the operating mechanism is configured to enable joint movement of the end effector around the distal end of the elongated body in a second direction different from the first direction.

5. The apparatus according to claim 3, wherein the operating mechanism includes a first linkage arm coupled to the first end effector element and a second linkage arm coupled to the second end effector element, and each of the first and second linkage arms includes a central hinge, thereby causing the first and second linkage arms to articulate away from each other around their respective central hinges, so as to selectively move the end effector from the first configuration to the second configuration by moving the distal end of each of the first and second linkage arms closer to the corresponding proximal end of the first and second linkage arms.

6. The aforementioned operating mechanism, At least one pulley coupled to the corresponding one of the first end effector element or the second end effector element, At least one tether coupled to the at least one pulley, the at least one tether being configured to be displaced longitudinally so as to rotate the at least one pulley and move the end effector between the first configuration and the second configuration, The apparatus according to claim 3, including the apparatus described in claim 3.

7. The apparatus according to claim 3, wherein the operating mechanism includes at least one rod, which is coupled to a corresponding one of the first end effector element or the second end effector element and configured to rotate to move the end effector between the first and second configurations.

8. The apparatus according to claim 7, wherein the at least one rod is coupled to the corresponding radially outer edge of the first end effector element or the second end effector element, in proximity to the corresponding radially outer edge of the first end effector element or the second end effector element.

9. The apparatus according to claim 1, further comprising at least one closing element coupled to the first end effector element and the second end effector element, configured to push the end effector toward the second configuration.

10. Each of the first end effector element and the second end effector element includes an alignment feature defined on its corresponding surface, The apparatus according to claim 1, wherein the alignment feature is configured to align the first and second end effector elements when the end effector moves to the second configuration, thereby facilitating the alignment of the first coupler element and the second coupler element.

11. A device comprising an interface, an elongated body coupled to the interface and extending longitudinally from the interface, and an end effector coupled to the distal end of the elongated body, The aforementioned end effector is, A first end effector element defining a first receptacle structured to hold a first coupler element of a coupler, wherein the first coupler element is configured to receive the axial end of a first blood vessel, A second end effector element defining a second receptacle structured to hold a second coupler element of the coupler, wherein the second coupler element is configured to receive the axial end of a second blood vessel, The end effector is configured to move between a first configuration in which at least a portion of the first end effector element is separated from the corresponding portion of the second end effector element, thereby separating the first coupler element from the second coupler element, and a second configuration in which at least the portion of the first end effector element is close to the corresponding portion of the second end effector element, thereby coupling the first coupler element to the second coupler element so as to connect the first vessel to the second vessel. A device in which each of the first end effector element and the second end effector element is configured to twist and bend along the respective axes of the first end effector element and the second end effector element in order to move between the first configuration and the second configuration.

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