Surgical tool and related methods

Abstract

A surgical device comprising a handle, including a lever operatively coupled to an actuation line, an elongated shaft operatively coupled the handle, the actuation line extending along the elongated shaft, an end effector operatively coupled to the elongated shaft, opposite the handle, the end effector operatively coupled to the actuation line, and at least one of an articulation plate and a ball-and-socket joint interposing at least two of the handle, the elongated shaft, and the end effector, where at least one of the articulation plate and the ball-and-socket joint is operatively coupled to control lines operatively coupled to a joystick of the handle, where the joystick of the handle is repositionable to control yaw and pitch changes between at least two of the handle, the elongated shaft, and the end effector.

Description

Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-WTitle: SURGICAL TOOL AND RELATED METHODSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from U.S. Provisional Patent application 63 / 749,071, filed 24 January 2025, as well as U.S. Provisional Patent application 63 / 749,418, filed 24 January 2025.FIELD OF TECHNOLOGY

[0002] The present disclosure relates generally to methods and devices for deploying an exclusion clip, and more specifically, to minimally invasive devices and methods of deploying an exclusion clip.

[0003] Current methods for left atrial appendage (LAA) closure include the use of scalpels, graspers, and needle drivers to amputate the LAA and sew up the remaining wound. While more universal, these devices can necessitate more operator training and require a higher skill level to use in the context of LAA closure.

[0004] Current LAA closure devices, e.g., clips, are restricted by their size and cannot be deployed via a minimally invasive trocar or port near or about five millimeters in internal diameter.

[0005] Therefore, there remains a need for methods and devices for occluding an LAA that may be deployed via a minimally invasive trocar near or about five millimeters in internal diameter, as well as a need for devices and methods that may be more intuitive and provide for parallel opening of smaller exclusion clips.INTRODUCTION TO THE INVENTION

[0006] Multiple medical devices for applying an exclusion clip are disclosed herein. An exemplary medical device may include a handle, an elongated shaft extending from the handle, the elongated shaft comprising a proximal end, a distal end, and a central lumen. The exemplary medical device may further include an end effector at the distal end of the elongated shaft, the end effector comprising a first jaw and a second jaw configured to engage with and deliver an exclusion clip to a target tissue, wherein the end effector comprises a linkPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wmechanism configured to move the first jaw and the second jaw relative to each other. The exemplary medical device may further comprise a plurality of cables extending through the central lumen. The exemplary medical device may further comprise an articulation plate coupled to the handle, where the articulation plate comprises a central opening and a plurality of peripheral openings, where each of the plurality of peripheral openings receives a screw, where each screw receives one of the plurality of cables for tensioning of the link mechanism. The exemplary medical device can further comprise an articulation joint coupling the articulation plate and the elongated shaft, the articulation joint configured to allow rotational movement between the handle and the elongated shaft.

[0007] The articulation joint can be a ball-and-socket joint. The exemplary medical device can further comprise an O-ring configured to engage with the ball-and-socket joint and the articulation plate to lock the ball-and-socket joint to prevent articulation of the end effector. The plurality of peripheral openings can comprise a D-shaped cross-section.

[0008] Each screw can include a through hole, where the through hole comprises a first through hole diameter and a second through hole diameter, where the first through hole diameter is smaller than the second through hole diameter. A first ball and a second ball can be coupled to each of the plurality of cables, where the first ball comprises a first ball diameter smaller than the first through hole diameter, where the second ball comprises a second ball diameter larger than the first through hole diameter, where pulling the cable distally pulls the first ball through the through hole and traps the second ball in order to tension the cable. The first ball can be coupled to a ball-and-socket joint within the end effector.

[0009] The cable can be crimped by the screw so that the cable is restricted from moving axially. The end effector can further comprise a ball-and-socket joint. The ball-and-socket joint can comprise a plurality of openings to which each of the plurality of cables couples to. A ball of the ball-and-socket joint can comprise a slot, where a socket of the ball-and socket joint comprises a pin, where the slot and the pin are coupled to prevent circumferential rotation of the ball-and-socket joint.

[0010] The link mechanism can comprise a plurality of linkage bars coupled to the first jaw and the second jaw, wherein the plurality of linkage bars transfers forces from the plurality of cables to the first jaw and the second jaw. The plurality of cables can each comprise a plurality of wires.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0011] In other variations, a system for excluding a left atrial appendage of a patient is disclosed. The exemplary system can comprise a handle, an elongated shaft extending from the handle, the elongated shaft comprising a proximal end, a distal end, and a central lumen extending along a longitudinal axis of the elongated shaft. The exemplary system can further include an end effector at the distal end of the elongated shaft, the end effector comprising a first jaw and a second jaw configured to engage with and deliver an exclusion clip to a target tissue, where the end effector comprises a link mechanism configured to move the first jaw and the second jaw relative to each other. The exemplary system can further comprise a plurality of cables extending through the central lumen. The exemplary system can further comprise an articulation plate coupled to the handle. The exemplary system can further comprise an articulation joint coupling the articulation plate and the shaft, the articulation joint configured to allow rotational movement between the handle and the elongated shaft. The handle can comprise a lever portion configured to rotate in a first plane perpendicular to the longitudinal axis, where the lever portion is configured to rotate in a second plane perpendicular to the first plane, where rotation of the lever portion in the first plane moves the end effector in a yaw direction and rotation of the lever portion in the second plane moves the end effector in a pitch direction.

[0012] The handle can further comprise a grip portion configured for gripping by an operator with one or more fingers, where the articulation plate is between the grip portion and the lever portion. The lever portion can rotate 45 degrees in a first direction and 45 degrees in a second direction in the first plane, where the lever portion rotates 45 degrees in a first direction and 45 degrees in a second direction in the second plane. The handle can further comprise a thumb portion extending from the lever portion, where the thumb portion extends at a 45-degree angle from the longitudinal axis of the elongated shaft.

[0013] In another variation, the exemplary medical device can comprise a handle, an elongated shaft extending from the handle, the elongated shaft comprising a proximal end, a distal end, and a central lumen. The exemplary medical device can further comprise an end effector at the distal end of the elongated shaft, the end effector comprising a first jaw and a second jaw configured to engage with and deliver the exclusion clip to a target tissue. The exemplary medical device can further comprise a plurality of cables extending through the central lumen. The medical device can further comprise an articulation plate coupled to the handle, where the articulation plate comprises a central opening and a plurality of peripheralPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wopenings, where each of the plurality of peripheral openings receives a screw. The exemplary medical device can further comprise an articulation joint coupling the articulation plate and the elongated shaft, the articulation joint configured to allow rotational movement between the handle and the elongated shaft. The medical device can further comprise an articulation lock system within the handle, where the articulation lock system comprises a ring configured to engage the articulation joint and the articulation plate so that the articulation joint and the articulation plate are locked, locking the end effector.

[0014] The articulation lock system can further comprise a brake actuator plate, where the brake actuator plate is configured to release the ring from engagement with the articulation joint and the articulation plate when the exclusion clip is released. An elastic member, e.g., a deployment spring or a clip release spring, can be coupled to the brake actuator plate. The elastic member’s primary purpose is to deploy the clip by retracting or pulling the deployment cables. After deployment has occurred, the articulation lock system is permanently disengaged, which allows the end effector to be removed through the port or trocar without reorienting the end effector to the neutral position.

[0015] An exemplary surgical device as described herein may include a handle, including a lever operatively coupled to an actuation line, an elongated shaft operatively coupled the handle, the actuation line extending along the elongated shaft, an end effector operatively coupled to the elongated shaft, opposite the handle, the end effector operatively coupled to the actuation line, at least one of an articulation plate and a ball-and-socket joint interposing at least two of the handle, the elongated shaft, and the end effector, where at least one of the articulation plate and the ball-and-socket joint is operatively coupled to control lines operatively coupled to a joystick of the handle, where the joystick of the handle is repositionable to control yaw and pitch changes between at least two of the handle, the elongated shaft, and the end effector. An exemplary surgical device may include an end effector having a pair of repositionable jaws removably coupled to an exclusion clip, the pair of repositionable jaws operatively coupled to an actuation line so that repositioning the actuation line repositions the pair of repositionable jaws and the exclusion clip when removably coupled thereto. The exemplary surgical device may include an exclusion clip that is enclosed and circumscribed entirely by a fabric cover as disclosed in U.S. Patent Application Publication No. 2025 / 0160847. The exemplary surgical device may include a handle having a depressible button operatively coupled to a release line, where the release line is springPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wbiased to removably couple an exclusion clip from a pair of jaws of the end effector when the depressible button is depressed. The exemplary surgical device may include an end effector having a linkage repositionable between an expanded position and a contracted position, the linkage operatively coupled to a pair of jaws that are removably coupled to an exclusion clip. The exemplary surgical device may include one or more control lines tensioned using a tension screw or a plurality of tension screws. The exemplary surgical device may include a handle configured to allow single hand control over a first control that is configured to cause repositioning of an end effector, a second control for disengaging an exclusion clip from the end effector, and a third control to at least one of open and close the exclusion clip while engaging the end effector. The exemplary surgical device may include an end effector includes a first jaw and a second jaw, with at least one of the first jaw and the second jaw being repositionable to vary a spacing therebetween, the first jaw is removably coupled to a first beam of an exclusion clip, the second jaw is removably coupled to a second beam of the exclusion clip, the exclusion clip is repositionable between an open position and a closed position, and / or the exclusion clip lies flat in both the open position and the closed position. The exemplary surgical device may include a first ball-and-socket joint operatively coupling a handle to an elongated shaft, and / or a second ball-and-socket joint operatively coupling the elongated shaft to an end effector removably coupled to an exclusion clip.

[0016] An exemplary method of using a surgical device as described herein may include one or more steps of delivering an exclusion clip, removably coupled to an end effector of a surgical device, proximate a left atrial appendage, the surgical device including a handle controller operatively coupled to an elongated shaft, which is operatively coupled to the end effector, thumb controlling a joystick of the handle controller to vary pitch and yaw between at least two of the handle controller, the elongated shaft, and the end effector in order to reposition opposed beams of the exclusion clip so that a base of the left atrial appendage interposes the opposed beams, removing the exclusion clip from the end effector while the base of the left atrial appendage interposes the opposed beams, and repositioning the surgical device so that the end effector is no longer proximate the left atrial appendage but the exclusion clip is. An exemplary method of using a surgical device as described herein may include using a joystick operatively coupled to at least one of an articulation plate and a ball-and-socket joint, and thumb controlling the joystick of a handle controller to reposition a plurality of control lines coupled to at least one of the articulation plate and the ball-and-socket joint, andPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wconcurrently operatively coupled to at least one of the handle controller, an elongated shaft, and an end effector removably coupled to an exclusion clip. An exemplary method of using a surgical device as described herein may include an exclusion clip that is enclosed, the exclusion clip is configured to circumscribe a left atrial appendage when a base of the left atrial appendage interposes the opposed beams, where the exclusion clip is covered in a fabric, and where the fabric circumscribes the left atrial appendage when the base of the left atrial appendage interposes the opposed beams. An exemplary method of using a surgical device as described herein may include removing an exclusion clip from an end effector by depressing a release of a handle controller to automatically retract a retention line extending between the handle controller and the end effector. An exemplary method of using a surgical device as described herein may include thumb controlling a joystick of a handle controller to reposition the joystick while the joystick is unlocked via a lock of the handle controller. An exemplary method of using a surgical device as described herein may include thumb controlling a joy stick of a handle controller to vary both the yaw and pitch of an end effector with respect to an elongated shaft. An exemplary method of using a surgical device as described herein may include thumb controlling a joystick of a handle controller to vary both the yaw and pitch of an elongated shaft with respect to the handle controller.

[0017] An exemplary method of fabricating a surgical device as described herein may include one or more steps of operatively coupling a handle controller to an elongated shaft, operatively coupling an end effector to the elongated shaft, removably coupling an exclusion clip to the end effector, using at least one of an articulation plate and a ball-and-socket joint to interpose at least two of the handle controller, the elongated shaft, and the end effector, operatively coupling a thumb control of the handle controller with at least one of the articulation plate and the ball-and-socket joint, where the thumb control is repositionable front-to-back and side-to-side. An exemplary method of fabricating a surgical device as described herein may include providing an end effector having a first jaw repositionable with respect to a second jaw, removably coupling an exclusion clip to the end effector by removably mounting a first beam of the exclusion clip to the first jaw, and removably mounting a second beam of the exclusion clip to the second jaw, and, optionally, operatively coupling a button or trigger associated with a handle controller with a first disengagement link interposing the first beam and the first jaw, and a second disengagement link interposing the second beam and the second jaw. An exemplary method of fabricating a surgical device as described herein may include providingPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wa plurality of cables extending from at least one of an articulation plate and a ball-and-socket joint, where at least one of the plurality of cables is operatively coupled to a tension screw, and rotating the tension screw to tension at least one of the plurality of cables operatively coupled thereto. An exemplary method of fabricating a surgical device as described herein may include assembling a handle controller so that the handle controller can be gripped and retained in place using a single hand, where the handle controller may include one or more of three operative controls comprising: (i) a thumb control configured to control yaw and pitch between at least two of the handle controller, an elongated shaft, and an end effector, the thumb control configured to be manipulated by a thumb (digit 1) of the single hand, (ii) an exclusion clip disengagement control configured to selectively disengage an exclusion clip from the end effector and to be manipulated by an index finger (digit 2) of the single hand, and (iii) an exclusion clip opening / closing control configured to selectively open / close the exclusion clip when coupled to the end effector and to be manipulated by at least one of a middle finger (digit 3), a ring finger (digit 4), and a little finger (digit 5) of the single hand.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 illustrates a side view of a device for applying a clip to exclude the left atrial appendage.

[0019] FIG. 2A illustrates one variation of a tensioning screw used in conjunction with the articulation plate.

[0020] FIG. 2B illustrates one variation of a screw assembly and a corresponding method of tensioning the peripheral cables.

[0021] FIG. 2C illustrates another variation of a screw assembly and a corresponding method of tensioning the peripheral cables.

[0022] FIG. 2D illustrates another variation of a screw assembly and a corresponding method of tensioning the peripheral cables in which the screw further comprises a crimping element that surrounds the cable.

[0023] FIG. 3 A illustrates one variation of a handle in accordance with the present disclosure.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0024] FIG. 3B illustrates a front view of the articulation plate comprising a central opening and peripheral openings surrounding the central opening.

[0025] FIG. 3C illustrates a diagram of the thumb portion in relation to the longitudinal axis of the elongated shaft.

[0026] FIGS. 3D and 3E illustrate views of variations of the handle being held by a user.

[0027] FIG. 4 illustrates the proximal ball and socket with an articulation lock designed to secure the end effector as desired by the user, as well as the coupling of the deployment spring mechanism to the articulation lock.

[0028] FIGS. 5A and 5B illustrate the distal ball-and-socket joint that enables the end effector to accomplish pitch and yaw inputs with a single control.

[0029] FIG. 6 illustrates a handle according to another variation of the device.

[0030] FIGS. 7A-7E illustrate the end effector at various positions during use.

[0031] FIG. 8 illustrates another variation of the device that provides rotation to the end effector.

[0032] FIG. 9A illustrates a profile view an alternate exemplary end effector in a closed or compact configuration in accordance with the instant disclosure.

[0033] FIG. 9B illustrates a profile view the alternate exemplary end effector of FIG. 9A in an open or expanded configuration in accordance with the instant disclosure.

[0034] FIG. 10A illustrates a profile view of the alternate exemplary end effector of FIG. 9A in a closed or compact configuration and being mounted to an exclusion clip (closed) in accordance with the instant disclosure.

[0035] FIG. 10B illustrates a profile view of the alternate exemplary end effector of FIG. 9A in an open or expanded configuration and being mounted to an exclusion clip (also open) in accordance with the instant disclosure.

[0036] FIG. 11 A is a left side profile view of a first alternate exemplary handle in accordance with the instant disclosure, shown with the lever extended.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0037] FIG. 1 IB is a left side profile view of the first alternate exemplary handle of FIG. 11 A, shown with the lever retracted.

[0038] FIG. 11C is an elevated perspective view, from the distal end, of the first alternate exemplary handle of FIG. 11A.

[0039] FIG. 12A is a left side profile view of a second alternate exemplary handle in accordance with the instant disclosure, shown with the lever extended.

[0040] FIG. 12B is a left side profile view of the second alternate exemplary handle of FIG.12 A, shown with the lever retracted.

[0041] FIG. 12C is an elevated perspective view, from the distal end, of the second alternate exemplary handle of FIG. 12A.

[0042] FIG. 13 A is a left side profile view of a third alternate exemplary handle in accordance with the instant disclosure, shown with the lever extended.

[0043] FIG. 13B is a left side profile view of the third alternate exemplary handle of FIG.13 A, shown with the lever retracted.

[0044] FIG. 13C is an elevated perspective view, from the distal end, of the third alternate exemplary handle of FIG. 13A.

[0045] FIG. 14A is a left side profile view of a fourth alternate exemplary handle in accordance with the instant disclosure, shown with the lever extended.

[0046] FIG. 14B is a left side profile view of the fourth alternate exemplary handle of FIG.14 A, shown with the lever retracted.

[0047] FIG. 14C is an elevated perspective view, from the distal end, of the fourth alternate exemplary handle of FIG. 14A.DETAILED DESCRIPTION

[0048] The exemplary embodiments of the present disclosure are described and illustrated below to encompass devices, methods, and techniques relating to surgical devices, surgical procedures, and manufacturing surgical devices. Of course, it will be apparent to those ofPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wordinary skill in the art that the embodiments discussed below are exemplary in nature and may be reconfigured without departing from the scope and spirit of the present disclosure. It is also to be understood that variations of the exemplary embodiments contemplated by one of ordinary skill in the art shall concurrently comprise part of the instant disclosure. However, for clarity and precision, the exemplary embodiments as discussed below may include optional steps, methods, and features that one of ordinary skill should recognize as not being a requisite to fall within the scope of the present disclosure. For the avoidance of doubt, it should be understood that the following disclosure justifies the generalizing isolation of each of the features disclosed in any aspect or exemplary embodiment and the introduction into a claim herein is not an intermediate generalization. Moreover, it is to be understood that each of the features disclosed in any aspect or exemplary embodiment is not related or inextricably linked to the other features of that aspect or embodiment. In this manner, it is to be understood by one skilled in the art that the disclosure herein presents the skilled artisan with information regarding various combinations of features that are directly and unambiguously derivable from the originally filed application knowing the intention not to limit the examples described herein to all, a majority, or any specified combination of features disclosed. Unless otherwise noted, a feature disclosed herein is not essential to a claimed invention and one skilled in the art reviewing the instant disclosure should understand the same given this express pronouncement. Reciting each and every one of the various combinations of aspects and embodiments in accordance with the scope of this disclosure has been omitted, solely for purposes of brevity.

[0049] FIG. 1 illustrates a medical device 100 which may be used for applying an exclusion clip to exclude the left atrial appendage (LAA). The device 100 can comprise an end effector 102, an articulation plate 104 coupled to a handle (not shown), and an elongated shaft 106 comprising a longitudinal axis and a central lumen 600 (see FIG. 6) extending between the end effector 102 and articulation plate 104.

[0050] The end effector 102 can comprise a first jaw 108, a second jaw 110, and a linkage mechanism 112 that connects the jaws 108, 110 to a base portion 114. A plurality of pins 116 can be used to connect various parts of the linkage mechanism 112. The first jaw 108 and the second jaw 110 can extend from the linkage mechanism 112 and can move relative to each other to deliver a clip 118 around the LAA or other anatomical structure. Reference is madePatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wto commonly owned U.S. Patent Application Publication No. 2023 / 0082963 and U.S. Patent No. 12,053,185, issued 6 August 2024, the entireties of which are incorporated by reference.

[0051] It should be understood that the end effector 102 can be used to apply clips at other target tissue or target areas of the anatomy, however. As will be described below, the linkage mechanism 112 can comprise a plurality of linkage bars configured to transition the jaws 108, 110 between a first, compact configuration and a second, expanded configuration (as seen in FIGS. 7A-E).

[0052] The end effector 102 can be configured to fit in a conventional port or trocar of about 5 mm to 7 mm (e.g., about 5.9 mm), as well as a minimally invasive trocar (being a 5mm or smaller trocar) commonly used in thoracic surgeries. The smaller the port or trocar size is, the higher the likelihood of reduced pain and trauma to the patient as access between the ribs is tight and the proximity of surrounding nerves. The elongated shaft 106 can thus comprise a diameter of less than 5 mm to about 7 mm to fit through smaller trocars and to permit bending if necessary.

[0053] The end effector 102 in the first, compact configuration (see FIG. 7 A) can have a diameter of about 5.84 mm. The end effector 102 can be configured to open clip sizes in the second, expanded configuration (see FIG. 7C) of about 20 mm in order to open the inside of the clip to approximately 14 mm.

[0054] The elongated shaft 106 can comprise a plurality of clip opening cables 120 within the central lumen. The central cables 307 can extend through a central opening of the articulation plate 104 (see FIG. 3B) and into the handle so that the handle can control the first jaw 108 and the second jaw 110 moving with respect to each other, as will be described below.

[0055] A plurality of peripheral cables 120 can exit the elongated shaft 106 at the proximal end of the elongated shaft 106 and into one or more peripheral openings 122 of the articulation plate 104. The cables 120, 307 can thus extend from the linkage mechanism 112 to their respective components in the handle and can be used to control the end effector 102 via the handle. For example, the peripheral cables 120 can be used to articulate the end effector 102 in both pitch and yaw directions with respect to a central plane of the device 100.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0056] The articulation plate 104 and the elongated shaft 106 can comprise a proximal ball-and-socket joint 124 therebetween. A ball of the proximal ball-and-socket joint 124 can comprise an opening through the center to allow the opening and a plurality of cables to exit and interface with their control elements in the handle. The proximal ball-and socket joint 124 can accordingly allow for rotation between the handle and the elongated shaft 106.

[0057] The plurality of peripheral cables 120 can exit the articulation plate 104 and to the handle through a plurality of screws 128 placed within the peripheral openings 122 of the articulation plate 104.

[0058] The end effector 102 and the elongated shaft 106 can comprise a distal ball-and socket joint 130 therebetween. The distal ball-and-socket joint 130 can be articulated by the handle to rotate the end effector as desired. The distal ball-and-socket joint 130 can be locked by the handle when such movement is no longer desired. The distal ball-and-socket joint 130 can be as close to the end effector 102 as possible to reduce the dead space so the end effector 102 can provide articulation in the limited space between a trocar and the LAA, for example.

[0059] The distal ball-and-socket joint 130 can be compact in order to operate in the limited space between the end of the trocar and the LAA. Accordingly, the distal ball-and-socket joint 130 can fit within a trocar or port of about 5 mm diameter or less. The stiffness of the distal ball-and-socket joint 130 can be optimized so the clip can be pushed to the base of the LAA during deployment. Stiffness or resistance to relative motion between the rigid ball and rigid socket is a function of friction between the ball and socket and normal force between the ball and socket.

[0060] Each of the cables 120, 307 (central cables or peripheral cables) can comprise a 1x7 wire (e.g., seven wires within one bundle) construction, however, other cable constructions can be used. The cables 120, 307 can comprise a diameter of about 0.016 inches. The cables 120, 307 can comprise a minimum breaking strength of about 30 lbs. The cables 120, 307 can be made or stainless steel, though other materials can be used (e.g., aluminum, copper, titanium, tungsten, etc.).

[0061] In other variations, the cables 120, 307 can comprise various wire constructions that can vary in strength and flexibility. In some variations, the cables 120, 307 can comprise a 1x19 wire (e.g., nineteen wires within one bundle).Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0062] In other variations, the cables 120, 307 can comprise multiple cables made of multiple wires. For example, the cables 120, 307 can comprise a 3x7 configuration (21 total wires), a 7x7 configuration (49 total wires), a 7x19 configuration (133 total wires), or a 7x49 configuration (343 total wires).

[0063] FIG. 2A illustrates one variation of the tensioning screw 128 used in conjunction with the articulation plate 104. The tensioning screw 128 can comprise an opening 200 therethrough. The opening 200 can accommodate the peripheral cables 120, controlling the tension of the peripheral cables 120 for articulation of the end effector 102.

[0064] One technical problem encountered by the applicants is that current devices are built from the bottom up, so access to the cables for tensioning is limited to the top side. A manufacturing fixture using a complex series of pulleys and weights can often be used to set the cable tension. The forces from the cable tension are resolved in the handles, which may not be completely fixed until a final ultrasonic welding step. This results in variations in cable tension, so the articulation forces may not be consistent. One technical solution discovered by the applicants is to tension the peripheral cables 120 so that they are tight enough that the tension keeps end effector 102 rigid. At the same time, the peripheral cables should have some slack to decrease the friction within the device 100 so that the end effector 102 can still articulate. Accordingly, to ease manufacturing and to set the cable tension of the device 100 to desired levels, the screw assembly can be tensioned and aligned as a unit prior to being assembled into the handle. Such methods are described with respect to FIGS. 2B to 2D below. Regarding end effector “stiffness” or rigidity, the end effector is never truly rigid in order to permit movement. Instead, rigidity is defined primarily by the coefficient of friction between the ball and socket joint, and tension in the cable(s). If the articulation joint is locked, the stiffness of the cable(s) also affects the end effector stiffness. The peripheral cables aren’t intended to be slack. Slack peripheral cables imply zero tension and thus zero stiffness, which is not desired.

[0065] FIG. 2B illustrates one variation of a screw assembly and a corresponding method of tensioning the peripheral cables 120. This variation comprises a screw with an opening 200 comprising two inner diameters. In this variation, the peripheral cables 120 can be prefabricated to approximately its functional length in order to eliminate a termination step during manufacturing. The peripheral cable 120 can comprise a distal ball 202 having aPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wdiameter of about 0.03 inches and a proximal ball 204 having a diameter of about 0.06 inches. The screw 128 can comprise an opening 200 having two inner diameters: a first through hole 206 and a second through hole 208, the second through hole 208 comprising a larger diameter than a diameter of the first through hole 206. The distal ball 202 can pass through the screw 128 while the proximal ball 204 is trapped by a counterbore (i.e., where the opening 200 changes diameter). The distal ball 202 then feeds through the elongated shaft 106 and is attached to the distal ball-and-socket joint 130. It should be understood that the plurality of peripheral cables 120 can comprise the same length since the articulation function of the device 100 occurs in the same plane.

[0066] The screw 128 can fit through a D-shaped cross-section peripheral opening 122 in the articulation plate 104 and the tension can be set with a nut on the opposite side of the articulation plate 104. The screw 128 can have an anti-rotation feature such as a flat side (see FIG. 2A) to keep it from rotating as the cable 120 is tensioned. When the screw 128 is aligned, the tension can be set by counting additional turns on the nut(s). This way, various tensions can be quickly modified during development to determine the optimum user feel.

[0067] FIG. 2C illustrates another variation of a screw 128 assembly and a corresponding method of tensioning the peripheral cables in which the screw 128 comprises an opening 200 in which the peripheral cable 120 cannot move. During manufacturing, the screw 128 can be crimped to trap the cable in its place axially.

[0068] FIG. 2D illustrates another variation of a screw 128 assembly and a corresponding method of tensioning the peripheral cables in which the screw 128 further comprises a crimping element 210 that surrounds the peripheral cable 120. This sets the peripheral cable 120 in place when the correct tension is reached so that the peripheral cable 120 is unable to move axially.

[0069] One technical problem encountered by the applicants is maintaining end effector 102 rigidity while still providing articulation. One technical solution discovered by the applicants is to increase the pre-load on the peripheral cables 120. For example, if the articulation cable were not pre-loaded, a force on the end effector of 10 lbs. of tension would stretch the cable about 0.05 inches, resulting in considerable end-effector backlash. However, if the cable had a starting tension of 10 lbs., the same load would not deflect the end effector at all. The friction between the proximal ball-and-socket joint 124 can also help the rigidity of the end-effector.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0070] FIG. 3A illustrates one variation of a handle 300 in accordance with the present invention. The handle 300 can extend from the articulation plate 104 and can comprise a lever portion 302 and a thumb portion 304. The lever portion 302 can be configured to rotate in a first plane (e.g., a y-plane) perpendicular to the longitudinal axis of the elongated shaft 106 in order to move the end effector in a yaw direction. The lever portion 302 can be configured to rotate in a second plane perpendicular (e.g., a z-plane) to the first plane in order to move the end effector in a pitch direction.

[0071] FIG. 3B illustrates a front view of the articulation plate 104 comprising a central opening 306 and peripheral openings 122 surrounding the central opening 306. The central opening 306 can accommodate and mount a ball of the proximal ball-and-socket joint 124.

[0072] The central cables 307 can enter and exit an opening of the ball to interface with their control elements in the handle 300 to open and close the jaws 108, 110 of the end effector 102.

[0073] The peripheral cables 120 in the articulation plate 104 can be located further from the center than the peripheral cables 120 at the distal end near the end effector 102 (e.g., at the distal ball-and-socket joint 130). Accordingly, a small angular movement in the articulation plate 104 can result in greater movement at the end effector 102. For example, 10 degrees of articulation at the articulation plate 104 can be more than 20 degrees of articulation at the distal ball-and-socket joint 130.

[0074] The articulation plate 104 can comprise a round protrusion 508 inside the central opening 306 and engaging the slot 504 (see FIG. 5A) that can fit in between halves of the handle so that the articulation plate 104 is constrained in rotation around the longitudinal axis of the device, corresponding to shaft 106. Accordingly, the articulation plate 104 can rotate laterally in order to provide the yaw direction control (right and left). The rotating moment force can be achieved by the lever portion 302 and the thumb portion 304, which is located about 1 inch from the proximal ball-and-socket joint 124. The end effector 102 can be moved in the pitch direction (up and down) when the lever portion 302 is moved axially respective to the elongated shaft 106. For example, pushing the lever forward can move the end effector down with respect to the longitudinal axis. Likewise, the yaw controls can move the end effector 102 to the left when the thumb portion 304 is pushed to the left (with respect to the operator's point of view) to keep cable forces in line. In some variations, the articulation of the peripheral cables 120 can be reversed to change the articulation direction at the distal endPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wof the device 100. The antirotation feature, i.e., slot 504 and protrusion 503, does not preclude the shaft 106 itself from rotating as shown in FIG. 8. In fact, it is desirable to constrain the “roll” of the articulation control plate 104 in the handle, but still allow the user to rotate the end effector relative to the handle as in FIG. 8. When roll is activated in FIG. 8 the peripheral cables 307 will twist, but can still be actuated by the articulation control plate 104 with minimal loss.

[0075] FIG. 3C illustrates a variation where the thumb portion 304 is positioned at a 45-degree angle from the articulation plate 104, on the proximal side of the articulation plate 104. The thumb portion 304 can extend about 45 degrees from the longitudinal axis of the elongated shaft 106 so that it can share the motion for pitch and yaw of the end effector 102 at approximately the same force and distance for both (see e.g., FIG. 3C). This allows the user to control the end effector 102 in all directions from a single control point via their thumb (i.e., the user can use the thumb portion in a joystick-like manner).

[0076] FIGS. 3D and 3E illustrate a handle 300 comprising a control using a thumb portion 304 and a finger portion 308. The finger portion 308 can be used to add force to the control of the thumb portion 304, improving the ergonomics of the handle 300 for the user 310. The thumb portion 304 in FIG. 3D can be a bulb-shaped design. The thumb portion 304 in FIG.3E can comprise a concentric ring design to facilitate omnidirectional functionality with the thumb portion 304 in a potentially wet environment. The handle 300 can further comprise a clip opening control 312 that can actuate the jaws 108, 110 moving in relation to each other.

[0077] For ergonomic purposes, the handle 300 can be designed so the articulation plate 104 is in line with a user's carpometacarpal joint in the thumb located near the wrist. The carpometacarpal joint is also a ball joint, and accordingly, keeping it in line with the proximal ball-and-socket joint 124 mechanism in the handle 300 can minimize unwanted relative motion between the user's thumb and the lever portion 302.

[0078] FIG. 4 illustrates an articulation lock system 400 (or brake system) designed to secure the end effector 102 as desired by the user. The proximal ball-and-socket joint 124 can be locked when movement of the end effector 102 is no longer desired. The articulation lock system 400 can be within the handle 300 and can employ a high -friction, elastomeric O-ring 402 that can be pressed against the proximal ball-and-socket joint 124 to prevent the end effector 102 from back-driving when force is applied to the clip at the distal end of the devicePatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W100. That is, the articulation lock mechanism 400 in the handle prevents the end effector from being repositioned by loads applied at the end effector (e.g. back driving).

[0079] As seen in FIG. 4, the O-ring 402 can be positioned around the ball 404 and within a wedge-shaped opening between the articulation plate 104 and the proximal ball 404, allowing a relatively small amount of force to push the O-ring 402 into the opening where the force is effectively multiplied. When the O-ring 402 engages the wedge-shaped opening between the articulation plate 104 and the proximal ball 404, the proximal ball and-socket joint 124 can be locked from rotating in relation to the articulation plate 104. As the articulation plate 104 attempts to move, the friction generated tightens the O-ring 402 further, increasing the holding force. The end effector 102 can be locked when the O-ring 402 is in this position.

[0080] A brake actuator plate 406 can be connected to an elastic clip release spring 408 via a cable 410, so that when the clip is released, the lock is disengaged, enabling easy removal of the end effector 102 from the device 100.

[0081] The articulation lock system 400 is intended to increase friction sufficiently to stabilize the end effector 102. While in the locked position, the end effector 102 can still be repositioned by the user with the application of additional force. A cam-type mechanism (not shown) or lever could retract the brake actuator plate 406, causing the O-ring 402 to disengage from the slot, allowing the lever portion 302 of the handle 300 to move with minimal force.

[0082] In some variations, to eliminate a control from the device, it can be possible to use friction and / or force applied by the operator to keep the end effector 102 in the desired position. For example, the articulation lock system 400 may be eliminated. Instead, the operator can hold the position of the end effector study by maintaining pressure on the articulation plate.

[0083] In some variations, the O-ring 402 can be linked to the spring 408 for clip deployment so when the clip 118 is deployed the O-ring 402 will disengage. This ensures that the end effector 102 is removable (i.e., not locked in place) so that the end effector 102 can be pulled straight during removal from a trocar or port, for example. The O-ring 402 can engage rigid components such as the proximal ball-and-socket joint 124 in the handle 300.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0084] FIGS. 5A and 5B illustrate the distal ball-and-socket joint 130 that enables the end effector 102 to accomplish pitch and yaw adjustments using a single actuator. This can reduce the overall dead space on the pivoting section of the end effector 102 by about 0.375 inches, which can be helpful as the distance between the appendage and the distal end of the trocar or port can be limited, especially in smaller patients.

[0085] The distal ball 500 can comprise cable slots 502 where the peripheral cables 120 couple to. The cable slots 502 can act as channels for the peripheral cables 120 that get wider at the equator and southern hemisphere, i.e., toward the socket 506, proportionately, so articulation off center does not change the cable tension. In some variations, the length of the peripheral cables 120 does not change as the end effector 102 is pivoted to keep the articulation force constant.

[0086] A slot 504 on the ball and a pin at the equator of the socket 508 can prevent the distal ball 500 from rotating circumferentially. The peripheral cables 120 can always be in tension so that they will hold the distal ball-and-socket joint 130 together.

[0087] Since the peripheral cable 120 tension can be high, it is important to minimize friction between the distal ball 500 and the socket 506. Accordingly, the socket 506 can be made of materials such as nylon or polyetherimide to reduce friction and to provide adequate strength for the socket 506. Additionally, the surface finish and fit between the proximal ball 404 and socket 104 can impact the friction force to articulate.

[0088] In some variations, hypotubes, i.e., thin-walled stainless tubes, can be crimped outside of the peripheral cables 120 to help maintain the end-effector rigidity, compensating for increased cable loads and subsequent cable stretch. In some variations, a tungsten alloy cable can be used to bolster the strength of the peripheral cables 120 by about 30% while increasing the flexibility of the cables.

[0089] FIG. 6 illustrates a handle 300 according to another variation of the device 100. The handle 300 can comprise an articulation lever 602 and a clip opening lever 604. The handle 300 can be positioned at a proximal end of an elongated shaft. An end effector (not shown) can be positioned at a distal end of the elongated shaft 106, as described above in regards to FIG. 1.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0090] The articulation lever 602 can be positioned at a top of the handle 300 so that the user can control the articulation lever 602 with their thumb while holding the handle 300 with one hand. The articulation lever 602 can be configured so that motion of the lever corresponds with the end effector so as to be intuitive to the user.

[0091] The clip opening lever 604 can comprise a ring shape on an underside of the handle 300 so that the user can control the clip opening lever 604 with one finger while holding the handle 300 with the same hand. The clip opening lever 604 can provide control to open and close the clip without requiring substantial force from the user.

[0092] In some variations, the clip opening lever 604 can be a momentary control so that the end effector 102 only moves when the clip opening lever 604 is depressed. The opening 200 in the clip opening lever 604 can be used for the opening function, so that the other fingers of the user are available for the lock lever. The clip opening lever 604 can also be an on-off lock. On-off lock, i.e., cartoid mechanism, works like a ball point pen mechanism. It allows the clip to be locked in the open position by fully compressing the lever and releasing pressure, causing the lever to engage the locked position. When the lever is fully compressed a second time and pressure is released from the lever it will cause the lever to disengage the locked position and return to the fully open position while the clip returns to the fully closed position.

[0093] The clip opening lever 604 can transfer up to about 10 lbs. of force over a distance of about 0.500 inches to the clip opening central cables 307. The stroke of the clip opening lever 604 can be a specified length so that adequate mechanical advantage can be achieved with the lever mechanism. The mechanical advantage can be a result of stroke length and force applied to the clip opening lever 604. The applied force on the clip opening lever 604 can be reduced proportionately to the travel distance.

[0094] The clip opening function can be achieved with only the index finger as the ergonomics of the handle 300 allow for such. The index finger can hook the opening lever loop and provide a better grip on the device 100. In some variations, a 1-inch pull can provide a 3:1 reduction in force, and accordingly, the pulling force needed to open the clip can be about 3-4 lbs.

[0095] A clip release mechanism can provide tactile and audible feedback to ensure the clip has positively been released from the end effector. In some variations, the clip release mechanism can be a button on the clip opening lever 604.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0096] A single control point, e.g., thumb portion 304, can move the end effector 102 and allow for simultaneous motion. Since the articulation controls are simplified and can be done concurrently with the clip opening lever 604, in some variations, it may not be necessary to provide a separate lock for the articulation.

[0097] In some variations, the clip opening lever 604 can have a locking mechanism in the open position. To eliminate a separate button, the clip opening lever 604 can lock when the clip is open and can release if the clip opening lever 604 is pressed a second time.

[0098] FIGS. 7Ato 7E illustrate the end effector 102 at various positions during use. The end effector 102 can comprise one or more guide bars 701, one or more proximal linkage bars 700 and one or more distal linkage bars 702 linked to each other and forming an opening to receive the clip 118 via the jaws 108, 110. The jaws 108, 110 are not shown in FIGS. 7A-7C. The one or more guide and linkage bars 700, 701, 702 can pivot with respect to each other on one or more pins 116, 116a, 116b, 1620, 1636. As presented in FIGS. 7D-7E, the inboard ends of the guide bars 701 are coupled to a guide pin 116b in the base portion 114. The guide pin 116b like all the other pins 116, 116a, 1620, 1636 permits movement around the pin. The seven pins 116, 116a, 116b, 1620, 1636 can be about 0.03 inches in diameter and can be configured to minimize frictional losses. The inboard end of the proximal linkage bars 700 are coupled together by a drive link 116a, 1620. The outboard ends of the guide bars 701 and proximal linkage bars 700 are coupled to a jaw 108, 110 by a pin 116 at the proximal end of the jaw 108, 110. The inboard ends of the distal linkage bars 702 are coupled by a base pin 1636 to the distal end of the base portion 114. The outboard ends of the distal linkage bars 702 are coupled to the jaws 108, 110 distally from the pin coupling the guide bars 701 and proximal linkage bars 700 to the jaws 108, 110. FIG. 7A illustrates a first, compact configuration and FIG. 7C illustrates a second, expanded configuration. In the collapsed, compact position, with the jaws 108, 110 positioned close to each other, the drive link 116a, 1620 is extended distally from the base member 114 (see FIG. 7B). However, when the central cable 307 or opening cable 1604 draws the drive link 116a, 1620 proximally, toward the base pin 1636, the jaws 108, 110 are biased apart (see FIGS. 7D, 7E).

[0099] The two jaws 108, 110 can be positioned at an end of the linkage bars 700, 702. The clip attachment jaws 108, 110 can be substantially parallel with a longitudinal axis of the elongated shaft 106.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0100] One or more linkage bars 700, 702 can actuate an opening link mechanism that can transfer tensile forces from a central cable 307 to the clip attachment jaws 108, 110, as seen in FIGS. 7D and 7E. The central cable 307 can pass through a lumen of the shaft and can couple to the one or more linkage bars 700, 702. The central cable 307 can comprise a diameter of about 0.016 inches and can loop over the opening linkage pin 116a.

[0101] The end effector 102 can be configured to fit through a trocar or port of about 5 mm diameter and can take advantage of the fact that trocars or ports have an internal diameter slightly larger than their nominal description.

[0102] The end effector 102 can open the clip to an aperture of about 14 mm between the jaws 108, 110. The clip and end effector 102 can articulate from the central plane in both pitch (e.g., up and down) and yaw (e.g., left and right), as described above. The end effector can also be activated in “roll” degree of freedom around the longitudinal axis.

[0103] The cable 307 can fit in a space of about 0.02 inches provided between a center of the linkage bars 700, 702. The cable 307 can be rigged so that the cable 307 remains on the opening pivot pin 116a. The cable 307 can comprise a diameter of about 0.016 inches.

[0104] In some variations, the cable 307 can comprise a preformed "U" bend so that the cable 307 can straddle pivot pins 116a, 116b in the end effector 102. This configuration can double the cable strength to reduce stretching and to allow an adequate safety factor to the end effector 102. The safety factor can be further increased using tungsten alloy wires as the cable 307.

[0105] Both free ends of the cable 307 can be attached to a clip opening lever 604 in the handle 300. Since the preformed “U” shaped end of the opening cables can constrain the pivot pin 116, the end effector 102 can open symmetrically. In some variations, the cable 307 can also be mechanically attached to the pivot pin 116 of the proximal link bar. The load required to open the clip can be less than 10 lbs., and accordingly, a conventional cable can be used in some variations.

[0106] FIG. 8 illustrates another variation of the device 100 that provides rotation to the end effector 102. The device 100 can comprise a rotating cone 800 with one or more grooves 802 positioned thereon for improved ergonomics. The rotating cone 800 can be positioned on the elongated shaft 106 so that the elongated shaft 106 rotates with respect to the handle 300 whenPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wthe user rotates the rotating cone 800. Accordingly, the end effector 102 is rotated as the central cable 307 within the elongated shaft 106 twist to accommodate the rotation. Rotation of the end effector 102 can be limited to about 180 degrees to prevent binding by the interaction of the rotation pin 804 and rotation groove 806. The significant tension on the central cable 307 naturally provides resistance to prevent the elongated shaft 106 from rotating too freely. If a greater rotational locking force is desired, friction can be increased by using higher-friction materials at the interface of the handle 300 and rotating cone 800 or incorporating surface interlocking features to ensure more secure positioning.

[0107] Referring back to FIGS. 7A-7E, the distal linkage bars 702 and the proximal linkage bars 700 can be in compression so that they are subjected to buckling loads. The linkage bars can be about 0.03 inches thick. A buckling resistance of the linkage bars 700, 702 can be increased by increasing the thickness / width of the linkage bars 700, 702. Further, the buckling resistance laterally can be improved by tight-fitting pinned joints. The proximal linkage bars 700 can be in tension and can be configured for resolving the loads and providing lateral stability.

[0108] The linkage bars 700, 702 can be made from materials such as 17-4 stainless steel in order to have a safety factor to resolve the loads of opening the clip 118. In some variations, the end effector 102 can be made using a metal injection molding process or a metal 3-D printing process.

[0109] The end effector 102 can comprise two separate pivots, one for pitch and one for yaw, positioned about 0.375 inches apart. The distance from the first pivot to the proximal side of the clip when the clip is closed can be about 1.5 inches. The end effector 102 can articulate in a 40-degree deviation from zero degrees, centered, in both pitch and yaw directions.

[0110] For a conventional left-sided, sixth intercostal rib space surgical approach, the end effector 102 typically requires minimal articulation from the centerline. However, variations in anatomy, right-side bilateral access and other future applications can necessitate some degree of articulation. Since the elongated shaft 106 is relatively small in diameter, it can be beneficial to allow the elongated shaft 106 to allow for slight bends.

[0111] Turning to FIGS. 9A-10B, an alternate exemplary end effector 902 is depicted that may be used in lieu of the prior end effector 102 and be coupled to and extend from the distalPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wball-and-socket joint 130 of the elongated shaft 106. In exemplary form, the end effector 902 may include a first jaw 908, a second jaw 910, and a linkage mechanism 912 that connects the jaws 908, 910 to a base portion 914 (where the base portion 914 is connected to the distal ball-and-socket joint 130). A plurality of pins 916 can be used to connect various parts of the linkage mechanism 912. The first jaw 908 and the second jaw 910 can extend from the linkage mechanism 912 and can move relative to each other to deliver a clip 118 around the LAA or other anatomical structure.

[0112] It should be understood, however, that the end effector 902 can be used to apply clips at other target tissue or target areas of the anatomy. As will be described below, the linkage mechanism 912 may comprise a plurality of linkage bars configured to facilitate repositioning of the jaws 908, 910 between a first, compact configuration and a second, expanded configuration (compare FIGS. 9Ato 9B).

[0113] The end effector 902 can be configured to fit in a conventional port or trocar of about 4 mm to 7 mm. The end effector 902 in the first, compact configuration (see FIG. 10A) can have a diameter or maximum width of about 5.84 mm, depending on the scale of the components used. The end effector 902 can be configured to open an exclusion clip 118, as depicted by the second, expanded configuration (see FIG. 10B), to about 20 mm in order to open the inside of the clip to approximately 14 mm. In furtherance of brevity, the disclosure from U.S. Patent Application No. 19 / 033,741, published as U.S. Patent Application Publication No. 2025 / 0160847, is incorporated herein by reference in its entirety.

[0114] As with the first exemplary end effector 102, a central cable 307 can extend along the elongated shaft 106 and through a central opening of the articulation plate 104 (see FIG. 3B) and into the handle 300 so that the handle can control operation of the end effector 902, namely the first jaw 908 and the second jaw 910 moving with respect to each other, as will be described below.

[0115] In exemplary form, the end effector 902 may comprise two or more proximal linkage bars 920 and two or more distal linkage bars 922 individually coupled to a proximal housing or base portion 914 via the linkage pins 916 (that can be about 0.03 inches in diameter and can be configured to minimize frictional losses). Distal ends of each proximal and distal linkage bar 920, 922 are mounted to a respective jaw 908, 910 via linkage pins 916 so that the distal linkage bar 922 is longitudinally spaced from an adjacent proximal linkage bar 920,Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wwhile the proximal linkage bar 920 is mounted to a respective jaw near the jaw’s proximal end. Similarly, proximal ends of each proximal and distal linkage bar 920, 922 are mounted to the proximal housing or base portion 914 via linkage pins 916 so that the distal linkage bar 922 is longitudinally spaced from an adjacent proximal linkage bar, while the distal linkage bar 920 is mounted proximal to the housing’s distal end.

[0116] As with the first exemplary end effector, this end effector 902 is configured to selectively retain a clip 118 between the jaws 908, 910 using one or more suture ties 919. The linkage bars 920, 922 are configured to pivot with respect to each of the jaws 908, 910 and the housing 914 to move between the compact and expanded configurations via repositioning of the cable 307.

[0117] In exemplary form, distal portions of the central cables 307 may be divided, with one portion being routed and mounted to the first jaw 908 proximate where the first jaw mounts to a distal linkage bar 922, and a second portion being routed and mounted to the second jaw 910 proximate where the second jaw mounts to a distal linkage bar 922. In this manner, drawing the central cable 307 through the elongated shaft 106 and into the handle (such as handle 300, for example) is operative to overcome the bias of the clip 118 and move the jaws 908, 910 from the compact configuration toward the expanded configuration. Conversely, repositioning the central cable 307 through the elongated shaft 106 and out from the handle (when the clip 118 remains mounted the jaws) is operative to use the bias of the clip 118 to move the jaws 908, 910 from an expanded configuration toward a compact configuration.

[0118] In exemplary form, each of the distal linkage bars 922 may have the same longitudinal / overall length. Similarly, each of the proximal linkage bars 920 may have the same longitudinal / overall length, but a length that differs from the distal linkage bars 922. More specifically, the distal linkage bars 922 may be longer in longitudinal length than the proximal linkage bars 920. And this increase in length of the distal linkage bars 922 may provide an advantageous method of operation, as described below.

[0119] When in the compact configuration (see FIGS. 9 A and 10 A), the jaws 908, 910 of the end effector 902 are positioned in a parallel or near parallel arrangement. But as the jaws 908, 910 are repositioned from the compact configuration, and toward the expanded configuration (see Fig. 9B), the spacing between the jaws increases disproportionally, with the spacing at the distal ends increasing more rapidly than at the proximal ends (when no clip 118 is attachedPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wthereto). And when the clip 118 is mounted to thejaws 908, 910 via the sutures 919 (see FIGS.10A-10B), and thejaws are moved from the compact configuration and toward the expanded configuration, the tendency of the linkage mechanism 912 to open thejaws 908, 910 in a nonparallel fashion results in a force acting on the clip 118 (that overcomes the bias of the clip) that, if continued, is operative to open the clip in parallel even though thejaws are repositioned in a non-parallel fashion. As FIG. 10B reflects, thejaws 908, 910 deflect under the load / bias of the clip 118 toward one another, more so as the spacing between thejaws increases, where thejaws act as springs that deflect and eventually overcome the spring bias of the clip 118 to open the clip with the top and bottom of the clip opening in parallel despite thejaws 908, 910 not opening in parallel. Simply put, it has been found that one may use non-parallel jaw repositioning to achieve parallel clip opening, recognizing that thejaws 908, 910 will deflect or bend in response to the clip’s spring bias. The end effector 102 presented in FIGS. 7A-7E may operate according to the principle presented in FIGS. 9A-10B. Accordingly, when the distal linkage bars 702, 922 are longer than the proximal linkage bars 700, 920 thejaws 108, 110 will not be parallel when opened. In that situation, thejaws 108, 110 act as springs and flex under the load of the clip 118 (see FIG. 10B) while opening the clip 118 fully and evenly. This arrangement allows a balance between sufficient strength and compact size, which permits the end effector to fit though small ports or trocars.

[0120] A series of retention wires or deployment cables (not shown) may be threaded along the jaws 908, 910 to interface with suture ties 919 and be selectively disengaged from the suture ties via a control or trigger on the handle. The suture ties 919 form an aperture through which the deployment cable passes. In exemplary form, the handle may include a trigger that is operatively coupled to a deployment spring, which is operatively coupled to the retention wires so that operating the trigger causes the deployment spring to disengage the retention wires from the suture ties 919 and release the clip 118 from thejaws 908, 910.

[0121] Referring to FIGS. 11A-11C, a further first exemplary handle 1000 is depicted that may be used in lieu of any of the foregoing handles 300 and with any of the foregoing end effectors 102, 902, elongated shaft 106, and cables 120, 307. By way of example, the further first exemplary handle 1000 includes a clam shell housing that may be constructed from a plastic material comprising two complementary halves referred to as a right side housing 1002 and a left side housing 1004. These housings 1002, 1004 are operatively coupled to one another to delineate an internal cavity that houses several operative components. The housingsPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W1002, 1004 may be coupled to one another using detent fasteners or may be coupled to one another using a welded joint, such as, without limitation, an ultrasonically welded joint or a frictionally welded joint. When the housings 1002, 1004 are joined to one another, a three dimensional handle frame is formed that includes a bulbous distal section 1010 that tapers in all directions to form a narrowing, elongated proximal section 1012. The distal end 1008 of the distal section 1010 includes a funnel shape, tapering in the distal direction, to delineate a distal opening 1016 extending into the handle frame and being configured to receive a proximal portion of the elongated shaft 106. As referenced herein, the elongated shaft 106 may be stationarily or rotationally repositionably mounted to the handle 300, 1000.

[0122] An underneath side of the handle frame, in a portion of the distal section 1010 having an ever-increasing circumference as one travels proximally, includes an arcuate recess 1020. In exemplary form, the arcuate recess 1020 may be delineated by a portion of the housing having a saddle shape that curves upwards in one direction and downwards a direction orthogonal to the upward curvature direction. Just below the arcuate recess 1020, the housings 1002, 1004 converge to form a bottom-most stop 1030 that acts as a backstop or guard.

[0123] On a top side of the handle frame, opposite the underneath side of the handle frame, is an oblong depression 1040 that funnels and tapers to delineate a top opening that is occupied by a portion of a ball-and-socket joint 130. Namely a top of the distal ball 500 extends through the top opening, with a control stick 1042 extending from the distal ball. The stick 1042 corresponds to the thumb portion 304 described above and presented in FIGS. 3A-3E. In exemplary form, the stick 1042 includes a generally rounded T-shaped profile, with the upper portion of the stick being round in shape and having a frustoconical periphery 1044 that surrounds an arcuate depression 1046 formed at the very top and centered. The arcuate depression 1046 is intended to be large enough to accommodate at least a portion of the end of a person’s thumb. As discussed herein, the distal ball 500 is able to pivot in all directions around a central vertical axis extending up and through the top of the distal ball and, in this case, the vertical axis extends through the vertical component of the stick 1042. In this manner, a user can engage the end of his thumb with the depression 1046 and consequently pivot the stick 1042 and accordingly the distal ball 500 in order to effect changes in yaw and pitch of the end effector 102, 902.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0124] Centered, with respect to the lateral sides, on the top side of the handle frame may be a repositionable button 1050 positioned proximally with respect to the stick 1042. In exemplary form, the oblong depression 1040 may taper at its proximal end to delineate a frame 1052 within which the button 1050 may sit. A peripheral mesa 1054 may be formed to be upstanding from the surrounding surfaces of the top side of the handle frame and abut the frame 1052. As will be discussed in more detail hereafter, the mesa 1054 may be seated within the web space between a user’s thumb and index finger when the handle 1000 is grasped by a user’s hand. The button 1050 may be vertically and / or rotationally repositionable with respect to the housings 1002, 1004. In exemplary form, the button 1050 may be operatively coupled to a deployment spring within the handle, which is operatively coupled to deployment cables interposing the exclusion clip 118 and the jaws 108, 110, 908, 910 of the end effector 102, 902. Depressing the button or trigger 1050 may operate to release the deployment spring, which repositions the deployment cables from between the clip 118 and the jaws 108, 110, 908, 910 of the end effector 102, 902, thereby releasing the clip from the end effector. In exemplary form, the button 1050 may have, for example, a flat top, a rounded convex top, or a rounded concave top.

[0125] Centered, with respect to the lateral sides, on the undemeath / bottom side of the handle frame is an opening that receives a portion of a repositionable lever 1060. By way of example, the lever 1060 may be elongated to follow the curvature of the underside of the handle 1000 and include a pair of curved ends 1062 forming a concave recess utilized to ensure a user’s fingers stay within a predetermined range of longitudinal travel. The lever includes an actuator 1064 that extends at least partially into the handle halves 1002, 1004 and engages a mechanical coupling operatively coupled to the clip opening cable 307 in order to facilitate opening and closing of the exclusion clip 118.

[0126] In exemplary form, the lever 1060 may be similar to the clip opening lever 604 disclosed herein (see FIG. 6) and be used to overcome the bias of the exclusion clip 118 and reposition the jaws 108, 110, 908, 910 so as to reposition the clip between the compressed configuration (see, for example, Fig. 10A) and an expanded configuration (see, for example, FIG. 10B). In exemplary form, depressing the lever 1060 as depicted in FIG. 11B may correspond to the clip 118 being open as in FIG. 10B, whereas allowing the lever to extend maximally from the housing halves 1002, 1004 may correspond to the clip 118 being closed as in FIG. 10 A. By way of example, a user of the surgical device may control the lever 1060Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wwith one or more fingers while holding the handle 1000 with one hand. In this fashion, the lever 1060 can provide control to open and close the clip without requiring substantial force from the user.

[0127] In some variations, the lever 1060 can be a momentary control so that the end effector 102, 902 only moves when the lever 1060 is depressed. Conversely, the lever 1060 can also be an on-off lock. By way of example, the lever 1060 may transfer up to about 10 lbs. of force over a distance of about 0.4 inches of the clip opening cable 307. By way of further example, the stroke of the lever 1060 can be a specified length so that adequate mechanical advantage can be achieved with the lever mechanism. The mechanical advantage can be a result of stroke length and force applied to the lever 1060. The applied force on the lever 1060 can be reduced proportionately to the travel distance.

[0128] Extending proximally from the distal section 1010 is the elongated proximal section 1012, which has an arcuate longitudinal profile. In other words, from a rounded proximal end 1070 of the proximal section, the top surface curves upward until reaching the mesa 1054, which effectively defines a peak from the lateral side perspective. Moving distally from the mesa 1054 peak, the top surface declines in a generally linear descent. Conversely, on the bottom side, the elongated proximal section 1012 from the proximal end 1070 is also arced upward, but not as great as the arc on the top surface. This arc reaches a maximum and transitions into a steep downward arc, transitioning into a steep linear decline until reaching the stop 1030. The bottom surface then sharply increases in slope to delineate the arcuate finger recess 1020, followed by a gradual increase in slope until reaching the distal end 1008 of the distal section 1010.

[0129] In exemplary form, it is envisioned that a user of the surgical device would grasp the handle 1000 within one’s palm so that one’s fingers would wrap around a bottom of the housing halves 1002, 1004, with a portion of the user’s index finger seated within the arcuate finger recess 1020, and the other fingers (such as the middle, ring, and pinkie) would be seated on the lever 1060 in between the curved ends 1062. In this arrangement, the user’s palm would be seated, at least partially, upon the top surface of the handle 1000, with the user’s thumb having access to the stick 1042 and have a range of motion available to reposition / pivot the stick in any number of positions around 360 degrees. The user would then reposition the end effector, using the handle 1000, to be proximate a surgical site. Specifically, if the user wanted to change the pitch of the end effector 102, 902 up, one could use his thumb to pullPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wback (move proximally) on the stick 1042, whereas if the user wanted to change the pitch of the end effector 102, 902 down, one could use his thumb to push (move distally) on the stick 1042. Similarly, if the user wanted to change the yaw of the end effector 102, 902 to the right, one could use his thumb to move the stick 1042 to the right, whereas if the user wanted to change the yaw of the end effector 102, 902 to the left, one could use his thumb to move the stick 1042 to the left. Given the flexibility of the distal ball 500, various combinations of the foregoing are possible. And when the user desires to deploy the clip 118, the user would curl his fingers to cause the lever 1060 to move toward the underside of the housing halves 1002, 1004 until reaching a point where the clip was sufficiently opened, followed by placing the clip around the LAA or other anatomical structure, and thereafter uncurling his fingers to cause the lever 1060 to move away from the underside of the housing halves 1002, 1004 so that the clip was secured to the bodily tissue. Thereafter, the user would depress the button 1050, thereby releasing the clip 118 from the end effector 102, 902. At this time, the surgical device may be removed from the surgical site, such as by egressing through a trocar or port.

[0130] Referencing FIGS. 12A-12C, a further second exemplary handle 1100 is depicted that may be used in lieu of any of the foregoing handles 300, 1000 and with any of the foregoing end effectors 102, 902, elongated shaft 106, and cables 120, 307. By way of example, the further second exemplary handle 1100 includes a clam shell housing that may be constructed from a plastic material comprising two complementary halves referred to as a right side housing 1102 and a left side housing 1104. These housings 1102, 1104 are operatively coupled to one another to delineate an internal cavity that houses several operative components. The housings 1102, 1104 may be coupled to one another using detent fasteners or may be coupled to one another using a welded joint, such as, without limitation, an ultrasonically welded joint or a frictionally welded joint. When the housings 1102, 1104 are joined to one another, a three dimensional handle frame is formed that includes a bulbous distal section 1110 that tapers in all directions to form a narrowing, elongated proximal section 1112. The distal end 1108 of the distal section 1110 includes a funnel shape, tapering in the distal direction, to delineate a distal opening 1116 extending into the handle frame and being configured to receive a proximal portion of the elongated shaft 106. As referenced herein, the elongated shaft 106 may be stationarily or rotationally repositionably mounted to the handle 1100.

[0131] An underneath side of the handle frame, in a portion of the distal section 1110 having an ever-increasing circumference as one travels proximally, includes an arcuate openingPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wwithin which is seated an arcuate button 1120. This arcuate button 1120 may be vertically and / or rotationally repositionable with respect to the housings 1102, 1104. In exemplary form, the arcuate button 1120 may be operatively coupled to a mechanism, which is operatively coupled to the distal ball 500, in order to lock the position of the end effector in a given a yaw and pitch orientation. Depressing the arcuate button 1120 may operate to fix the yaw and pitch orientation of the end effector 102, 902, whereas depressing again or releasing the arcuate button may allow repositioning of the end effector to change at least one of its yaw and pitch orientation. In exemplary form, the arcuate button 1120 may have a saddle shape that curves upwards in one direction and downwards a direction orthogonal to the upward curvature direction. This saddle shape may generally conform to the saddle shape surrounding the button 1120 as delineated by the housings 1102, 1104. Below the arcuate opening and arcuate button 1120, the housings converge to form a bottom -most stop 1130 that acts as a backstop or guard.

[0132] On a top side of the handle frame, opposite the underneath side of the handle frame, is top depression 1140 having an arcuate profile and surrounds a two more openings 1142, 1144, one of which is occupied by a portion of a ball-and-socket joint 130. Namely a top of the distal ball 500 extends through the first opening 1142, with a stick 1146 extending from the distal ball. The stick 1146 corresponds to the thumb portion 304 described above and presented in FIGS. 3A-3E. In exemplary form, the stick 1146 includes a generally rounded T-shaped profile, with the upper portion of the stick being round in shape and having a depression formed at the very top and centered. The depression is intended to be large enough to accommodate at least a portion of the end of a person’s thumb. As discussed herein, the distal ball 500 is able to pivot in all directions around a central vertical axis extending up and through the top of the distal ball and, in this case, the vertical axis extends through the vertical component of the stick 1146. In this manner, a user can engage the end of his thumb with the depression and consequently pivot the stick 1146 and accordingly the distal ball 500 in order to effect changes in yaw and pitch of the end effector 102, 902.

[0133] Centered, with respect to the lateral sides, on the top side of the handle frame and within the second opening 1144 may be a repositionable button or trigger 1150 positioned proximally with respect to the stick 1146. In exemplary form, the top depression 1140 may taper at its proximal end to delineate a frame 1152 within which the button 1150 may sit. In exemplary form, the button 1150 may include a step 1154 that juts out from the surroundingPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wsurfaces of the button. As will be discussed in more detail hereafter, the step 1154 may be contacted by a user’s thumb to selectively release the clip 118 from the end effector 102, 902. The button or trigger 1150 may be vertically and / or rotationally repositionable with respect to the housings 1102, 1104. In exemplary form, the button 1150 may be operatively coupled to a deployment spring within the handle, which is operatively coupled to one or more deployment cables interposing the exclusion clip 118 and the jaws 108, 110, 908, 910 of the end effector 102, 902. Depressing the button 1150 may operate to release the deployment spring, which repositions the deployment cables from between the clip 118 and the jaws 108, 110, 908, 910 of the end effector 102, 902, thereby releasing the clip from the end effector. In exemplary form, the button 1150 may have, for example, a flat top, a rounded convex top, or a rounded concave top.

[0134] Centered, with respect to the lateral sides, on the undemeath / bottom side of the handle frame is an opening that receives a portion of a repositionable lever 1160. By way of example, the lever 1160 may be elongated to follow the curvature of the underside of the handle and include a pair of curved ends 1162 forming a concave recess utilized to ensure a user’s fingers stay within a predetermined range of longitudinal travel. The lever includes an actuator 1164 that extends at least partially into the handle halves 1102, 1104 and engages a mechanical coupling operatively coupled to the clip opening cable 307 in order to facilitate opening and closing of the exclusion clip 118.

[0135] In exemplary form, the lever 1160 may be similar to the clip opening lever 604 disclosed herein and be used to overcome the bias of the exclusion clip 118 and reposition the jaws 108, 110, 908, 910 so as to reposition the clip between the compressed configuration (see, for example, FIG. 10A) and an expanded configuration (see, for example, FIG. 10B). In exemplary form, depressing the lever 1160 as depicted in FIG. 12B may correspond to the clip 118 being open as in FIG. 10B, whereas allowing the lever to extend maximally from the housing halves 1102, 1104 may correspond to the clip 118 being closed as in FIG. 10 A. By way of example, a user of the surgical device may control the lever 1160 with one or more fingers while holding the handle 1100 with one hand. In this fashion, the lever 1160 can provide control to open and close the clip without requiring substantial force from the user.

[0136] In some variations, the lever 1160 can be a momentary control so that the end effector 102, 902 only moves when the lever 1160 is depressed. Conversely, the lever 1160 can alsoPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wbe an on-off lock. By way of example, the lever 1160 may transfer up to about 10 lbs. of force over a distance of about 0.4 inches of the clip opening cable 307. By way of further example, the stroke of the lever 1160 can be a specified length so that adequate mechanical advantage can be achieved with the lever mechanism. The mechanical advantage can be a result of stroke length and force applied to the lever 1160. The applied force on the lever 1160 can be reduced proportionately to the travel distance.

[0137] Extending proximally from the distal section 1110 is the elongated proximal section 1112, which has a steeply arcuate longitudinal profile. In other words, from a proximal end 1170 of the proximal section, the top surface curves steeply upward until reaching the proximal end of the top depression 1140. Moving distally from the distal end of the top depression 1140, the top surface declines in a generally linear descent. Conversely, on the bottom side, the elongated proximal section 1112 from the proximal end 1170 is also steeply arced upward, but not as great as the arc on the top surface. This arc reaches a maximum and transitions into a steep downward arc, transitioning into a steep linear decline until reaching the stop 1130. The bottom surface then sharply increases in slope to delineate an arcuate finger recess 1172, followed by a significant and steep curvature that flattens out approximately half way until reaching the distal end 1108 of the distal section 1110.

[0138] In exemplary form, it is envisioned that a user of the surgical device would grasp the handle 1100 within one’s palm so that one’s fingers would wrap around a bottom of the housing halves 1102, 1104, with a portion of the user’s index finger seated within the arcuate finger recess 1172, and the other fingers (such as the middle, ring, and pinkie) would be seated on the lever 1160 in between the curved ends 1162. In this arrangement, the user’s palm would be seated, at least partially, upon the top surface of the handle 1100, with the user’s thumb having access to the stick 1146 and have a range of motion available to reposition / pivot the stick in any number of positions around 360 degrees. The user would then reposition the end effector, using the handle 1100, to be proximate a surgical site. Specifically, if the user wanted to change the pitch of the end effector 102, 902 up, one could use his thumb to pull back (move proximally) on the stick 1146, whereas if the user wanted to change the pitch of the end effector 102, 902 down, one could use his thumb to push (move distally) on the stick 1146. Similarly, if the user wanted to change the yaw of the end effector 102, 902 to the right, one could use his thumb to move the stick 1146 to the right, whereas if the user wanted to change the yaw of the end effector 102, 902 to the left, one could use his thumb to move the stickPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W1146 to the left. Given the flexibility of the distal ball 500, various combinations of the foregoing are possible. Upon reaching the desired orientation of the end effector 102, 902 by repositioning the stick 1146, the user may reposition his index finger to depress the arcuate button 1120 in order to lock the orientation of the end effector. And when the user desires to deploy the clip 118, the user would curl his fingers to cause the lever 1160 to move toward the underside of the housing halves 1102, 1104 until reaching a point where the clip was sufficiently opened, followed by placing the clip around the LAA or other anatomical structure, and thereafter uncurling his fingers to cause the lever 1160 to move away from the underside of the housing halves 1102, 1104 so that the clip was secured to the bodily tissue. Thereafter, the user would depress the button 1150, thereby releasing the clip 118 from the end effector 102, 902. At this time, the surgical device may be removed from the surgical site, such as by egressing through a trocar.

[0139] Turning to FIGS. 13 A-13C, a further third exemplary handle 1200 is depicted that may be used in lieu of any of the foregoing handles 300, 1000, 1100 and with any of the foregoing end effectors 102, 902, elongated shaft 106, and cables 120, 307. By way of example, the further third exemplary handle 1200 includes a clam shell housing that may be constructed from a plastic material comprising two complementary halves referred to as a right side housing 1202 and a left side housing 1204. These housings 1202, 1204 are operatively coupled to one another to delineate an internal cavity that houses several operative components. The housings 1202, 1204 may be coupled to one another using detent fasteners or may be coupled to one another using a welded joint, such as, without limitation, an ultrasonically welded joint or a frictionally welded joint. When the housings 1202, 1204 are joined to one another, a three dimensional handle frame is formed that includes a bulbous distal section 1210 that tapers in all directions to form a narrowing, elongated proximal section 1212. The distal end 1208 of the distal section 1210 includes a funnel shape, tapering in the distal direction, to delineate a distal opening 1216 extending into the handle frame and being configured to receive a proximal portion of the elongated shaft 106. As referenced herein, the elongated shaft 106 may be stationarily or rotationally repositionably mounted to the handle 1200.

[0140] An underneath side of the handle frame, in a portion of the distal section 1210 having an ever-increasing circumference as one travels proximally, includes a substantially linear slope that terminates at a bottom-most stop 1230 that acts as a backstop or guard.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0141] On a top side of the handle frame, opposite the underneath side of the handle frame, is an oblong depression 1240 that funnels and tapers to delineate a top opening that is occupied by a portion of a ball-and-socket joint 130. Namely a top of the distal ball 500 extends through the top opening, with a stick 1242 extending from the distal ball. The stick 1242 corresponds to the thumb portion 304 described above and presented in FIGS. 3A-3E. In exemplary form, the stick 1242 includes a generally rounded T-shaped profile, with the upper portion of the stick being round in shape and having a frustoconical periphery 1244 that surrounds an arcuate depression 1246 formed at the very top and centered. The arcuate depression 1246 is intended to be large enough to accommodate at least a portion of the end of a person’s thumb. As discussed herein, the distal ball 500 is able to pivot in all directions around a central vertical axis extending up and through the top of the distal ball and, in this case, the vertical axis extends through the vertical component of the stick 1242. In this manner, a user can engage the end of his thumb with the depression 1246 and consequently pivot the stick 1242 and accordingly the distal ball 500 in order to effect changes in yaw and pitch of the end effector 102, 902.

[0142] Centered, with respect to the lateral sides, on the top side of the handle frame may be a repositionable button 1250 positioned proximally with respect to the stick 1242 and oblong depression 1240. The button 1250 may be vertically and / or rotationally repositionable with respect to the housings 1202, 1204. In exemplary form, the button 1250 may be operatively coupled to a spring within the handle, which is operatively coupled to deployment cables interposing the exclusion clip 118 and the jaws 108, 110, 908, 910 of the end effector 102, 902. Depressing the button 1250 may operate to release the spring, which repositions the deployment cables from between the clip 118 and the jaws 108, 110, 908, 910 of the end effector 102, 902, thereby releasing the clip from the end effector. In exemplary form, the button 1250 may have, for example, a flat top, a rounded convex top, or a rounded concave top.

[0143] Centered, with respect to the lateral sides, on the undemeath / bottom side of the handle frame is an opening that receives a portion of a repositionable lever 1260. By way of example, the lever 1260 may be elongated to follow the curvature of the underside of the handle and include a pair of curved ends 1262 forming a concave recess utilized to ensure a user’s fingers stay within a predetermined range of longitudinal travel. The lever includes an actuator 1264 that extends at least partially into the handle halves 1202, 1204 and engages a mechanicalPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wcoupling operatively coupled to the clip opening cable 307 in order to facilitate opening and closing of the exclusion clip 118.

[0144] In exemplary form, the lever 1260 may be similar to the clip opening lever 604 disclosed herein and be used to overcome the bias of the exclusion clip 118 and reposition the jaws 108, 110, 908, 910 so as to reposition the clip between the compressed configuration (see, for example, FIG. 10A) and an expanded configuration (see, for example, FIG. 10B). In exemplary form, depressing the lever 1260 as depicted in FIG. 1 IB may correspond to the clip 118 being open as in FIG. 10B, whereas allowing the lever to extend maximally from the housing halves 1202, 1204 may correspond to the clip 118 being closed as in FIG. 10 A. By way of example, a user of the surgical device may control the lever 1260 with one or more fingers while holding the handle 1200 with one hand. In this fashion, the lever 1260 can provide control to open and close the clip without requiring substantial force from the user.

[0145] In some variations, the lever 1260 can be a momentary control so that the end effector 102, 902 only moves when the lever 1260 is depressed. Conversely, the lever 1260 can also be an on-offlock. By way of example, the lever 1260 may transfer up to about 10 lbs. of force over a distance of about 0.4 inches of the clip opening cable 307. By way of further example, the stroke of the lever 1260 can be a specified length so that adequate mechanical advantage can be achieved with the lever mechanism. The mechanical advantage can be a result of stroke length and force applied to the lever 1260. The applied force on the lever 1260 can be reduced proportionately to the travel distance.

[0146] Extending proximally from the distal section 1210 is the elongated proximal section 1212, which has an arcuate longitudinal profile. In other words, from a rounded proximal end 1270 of the proximal section, the top surface curves upward until reaching a peak 1274 from the lateral side perspective. Moving distally from the peak 1274, the top surface declines in a generally linear descent. Conversely, on the bottom side, the elongated proximal section 1212 from the proximal end 1270 is also arced upward and then downward to delineate a U-shaped well 1276, bounded on a distal end by an elongated, rounded projection 1278. The bottom surface, continuing distally from the projection 1278, arcs upward and then downward to delineate a second U-shaped well 1280, which may be occupied by a portion of the lever 1260, and terminates at the stop 1230. The bottom surface then sharply increases in generally linear slope until reaching the distal end 1208 of the distal section 1210.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0147] In exemplary form, it is envisioned that a user of the surgical device would grasp the handle 1200 within one’s palm so that one’s fingers would wrap around a bottom of the housing halves 1202, 1204, with a portion of the user’s index finger seated just distal to the stop 1230, and the other fingers (such as the middle, ring, and pinkie) would be seated on the lever 1260 in between the curved ends 1262. In this arrangement, the user’s palm would be seated, at least partially, upon the top surface of the handle 1200, with the user’s thumb having access to the stick 1242 and have a range of motion available to reposition / pivot the stick in any number of positions around 360 degrees. The user would then reposition the end effector, using the handle 1200, to be proximate a surgical site. Specifically, if the user wanted to change the pitch of the end effector 102, 902 up, one could use his thumb to pull back (move proximally) on the stick 1242, whereas if the user wanted to change the pitch of the end effector 102, 902 down, one could use his thumb to push (move distally) on the stick 1242. Similarly, if the user wanted to change the yaw of the end effector 102, 902 to the right, one could use his thumb to move the stick 1242 to the right, whereas if the user wanted to change the yaw of the end effector 102, 902 to the left, one could use his thumb to move the stick 1242 to the left. Given the flexibility of the distal ball 500, various combinations of the foregoing are possible. And when the user desires to deploy the clip 118, the user would curl his fingers to cause the lever 1260 to move toward the underside of the housing halves 1202, 1204 until reaching a point where the clip was sufficiently opened, followed by placing the clip around the LAA or other anatomical structure, and thereafter uncurling his fingers to cause the lever 1260 to move away from the underside of the housing halves 1202, 1204 so that the clip was secured to the bodily tissue. Thereafter, the user would depress the button 1250, thereby releasing the clip 118 from the end effector 102, 902. At this time, the surgical device may be removed from the surgical site, such as by egressing through a trocar.

[0148] Referencing FIGS. 14A-14C, a further fourth exemplary handle 1300 is depicted that may be used in lieu of any of the foregoing handles 300, 1000, 1100, 1200 and with any of the foregoing end effectors 102, 902, elongated shaft 106, and cables 120, 307. By way of example, the further fourth exemplary handle 1300 includes a clam shell housing that may be constructed from a plastic material comprising two complementary halves referred to as a right side housing 1302 and a left side housing 1304. These housings 1302, 1304 are operatively coupled to one another to delineate an internal cavity that houses several operative components. The housings 1302, 1304 may be coupled to one another using detent fastenersPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wor may be coupled to one another using a welded joint, such as, without limitation, an ultrasonically welded joint or a frictionally welded joint. When the housings 1302, 1304 are joined to one another, a three dimensional handle frame is formed that includes a bulbous distal section 1310 that tapers in all directions to form a narrowing, elongated proximal section 1312. The distal end 1308 of the distal section 1310 includes a funnel shape, tapering in the distal direction, to delineate a distal opening 1316 extending into the handle frame and being configured to receive a proximal portion of the elongated shaft 106. As referenced herein, the elongated shaft 106 may be stationarily or rotationally repositionably mounted to the handle 1300.

[0149] An underneath side of the handle frame, in a portion of the distal section 1310 having an ever-increasing circumference as one travels proximally, delineates a pair of arcuate depressions 1312, 1314, where a trigger 1320 is seated within the first arcuate depression. This trigger 1320 may be vertically and / or rotationally repositionable with respect to the housings 1302, 1304. In exemplary form, the trigger 1320 may be operatively coupled to a mechanism, which is operatively coupled to the distal ball, in order to lock the position of the end effector in a given a yaw and pitch orientation. Repositioning the trigger 1320 may operate to fix the yaw and pitch orientation of the end effector 102, 902, whereas depressing again or releasing the arcuate button may allow repositioning of the end effector to change at least one of its yaw and pitch orientation. In exemplary form, the trigger 1320 may have arcuate shape that curves downward going proximally. Below the arcuate depressions 1312, 1314, the housings converge to form a bottom-most stop 1330 that acts as a backstop or guard.

[0150] On a top side of the handle frame, opposite the underneath side of the handle frame, is top depression 1340 having an oblong shape that surrounds an opening through which a portion of a ball-and-socket joint 130 emerges. Namely a top of the distal ball 500 extends through the first opening 1342, with a stick 1346 extending from the distal ball. The stick 1346 corresponds to the thumb portion 304 described above and presented in FIGS. 3A-3E. In exemplary form, the stick 1346 includes a T-shaped profile, with the upper portion of the stick being round in shape and having a depression 1348 formed at the very top and centered. The depression 1348 is intended to be large enough to accommodate at least a portion of the end of a person’s thumb. As discussed herein, the distal ball 500 is able to pivot in all directions around a central vertical axis extending up and through the top of the distal ball and, in this case, the vertical axis extends through the vertical component of the stick 1346. In thisPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wmanner, a user can engage the end of his thumb with the depression 1348 and consequently pivot the stick 1346 and accordingly the distal ball 500 in order to effect changes in yaw and pitch of the end effector 102, 902.

[0151] Centered, with respect to the lateral sides, on the top side of the handle frame and within the top depression 1340 may be a repositionable button 1350 positioned proximally with respect to the stick 1346. In exemplary form, the button 1350 may be contacted by a user’s thumb to selectively release the clip 118 from the end effector 102, 902. The button 1350 may be vertically and / or rotationally repositionable with respect to the housings 1302, 1304. In exemplary form, the button 1350 may be operatively coupled to a spring within the handle, which is operatively coupled to one or more deployment cables interposing the exclusion clip 118 and the jaws 108, 110, 908, 910 of the end effector 102, 902. Depressing the button 1350 may operate to release the spring, which repositions the deployment cables from between the clip 118 and the jaws 108, 110, 908, 910 of the end effector 102, 902, thereby releasing the clip from the end effector. In exemplary form, the button 1350 may have, for example, a flat top, a rounded convex top, or a rounded concave top.

[0152] Centered, with respect to the lateral sides, on the undemeath / bottom side of the handle frame is an opening that receives a portion of a repositionable lever 1360. By way of example, the lever 1360 may be elongated to follow the curvature of the underside of the handle and includes a curved end 1362 forming a concave recess utilized to ensure a user’s fingers stay within a predetermined range of longitudinal travel. The lever includes an actuator 1364 that extends at least partially into the handle halves 1302, 1304 and engages a mechanical coupling operatively coupled to the clip opening cable 307 in order to facilitate opening and closing of the exclusion clip 118.

[0153] In exemplary form, the lever 1360 may be similar to the clip opening lever 604 disclosed herein and be used to overcome the bias of the exclusion clip 118 and reposition the jaws 108, 110, 908, 910 so as to reposition the clip between the compressed configuration (see, for example, FIG. 10A) and an expanded configuration (see, for example, FIG. 10B). In exemplary form, depressing the lever 1360 as depicted in FIG. 12B may correspond to the clip 118 being open as in FIG. 10B, whereas allowing the lever to extend maximally from the housing halves 1302, 1104 may correspond to the clip 118 being closed as in FIG. 10 A. By way of example, a user of the surgical device may control the lever 1360 with one or morePatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wfingers while holding the handle 1300 with one hand. In this fashion, the lever 1360 can provide control to open and close the clip without requiring substantial force from the user.

[0154] In some variations, the lever 1360 can be a momentary control so that the end effector 102, 902 only moves when the lever 1360 is depressed. Conversely, the lever 1360 can also be an on-off lock. By way of example, the lever 1360 may transfer up to about 10 lbs. of force over a distance of about 0.4 inches of the clip opening cable 307. By way of further example, the stroke of the lever 1360 can be a specified length so that adequate mechanical advantage can be achieved with the lever mechanism. The mechanical advantage can be a result of stroke length and force applied to the lever 1360. The applied force on the lever 1360 can be reduced proportionately to the travel distance.

[0155] Extending proximally from the distal section 1310 is the elongated proximal section 1312, which has an arcuate longitudinal profile. In other words, from a proximal end 1370 of the proximal section, the top surface curves upward until reaching the proximal end of the top depression 1340. Moving distally from the distal end of the top depression 1340, the top surface declines in a generally linear descent. Conversely, on the bottom side, the elongated proximal section 1312 from the proximal end 1370 is also arced upward, but not as great as the arc on the top surface. This arc reaches a maximum and transitions into a steep downward arc until reaching the stop 1330. The bottom surface then increases in slope to delineate the arcuate depressions 1312, 1314, followed by a significant and steep incline that terminates upon reaching the distal end 1308 of the distal section 1310.

[0156] In exemplary form, it is envisioned that a user of the surgical device would grasp the handle 1300 within one’s palm so that one’s fingers would wrap around a bottom of the housing halves 1302, 1304, with a portion of the user’s index finger seated within a second of the arcuate depressions 1314, and the other fingers (such as the middle, ring, and pinkie) would be seated on the lever 1360 adjacent the curved end 1362. In this arrangement, the user’s palm would be seated, at least partially, upon the top surface of the handle 1300, with the user’s thumb having access to the stick 1346 and have a range of motion available to reposition / pivot the stick in any number of positions around 360 degrees. The user would then reposition the end effector, using the handle 1300, to be proximate a surgical site. Specifically, if the user wanted to change the pitch of the end effector 102, 902 up, one could use his thumb to pull back (move proximally) on the stick 1346, whereas if the user wanted to change the pitch ofPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wthe end effector 102, 902 down, one could use his thumb to push (move distally) on the stick 1346. Similarly, if the user wanted to change the yaw of the end effector 102, 902 to the right, one could use his thumb to move the stick 1346 to the right, whereas if the user wanted to change the yaw of the end effector 102, 902 to the left, one could use his thumb to move the stick 1346 to the left. Given the flexibility of the distal ball 500, various combinations of the foregoing are possible. Upon reaching the desired orientation of the end effector 102, 902 by repositioning the stick 1346, the user may reposition his index finger to reposition the trigger 1320 in order to lock the orientation of the end effector. And when the user desires to deploy the clip 118, the user would curl his fingers to cause the lever 1360 to move toward the underside of the housing halves 1302, 1304 until reaching a point where the clip was sufficiently opened, followed by placing the clip around the LAA or other anatomical structure, and thereafter uncurling his fingers to cause the lever 1360 to move away from the underside of the housing halves 1302, 1304 so that the clip was secured to the bodily tissue. Thereafter, the user would depress the button 1350, thereby releasing the clip 118 from the end effector 102, 902. At this time, the surgical device may be removed from the surgical site, such as by egressing through a trocar.

[0157] A number of embodiments have been described. Nevertheless, it will be understood by one of ordinary skill in the art that various changes and modifications can be made to this disclosure without departing from the spirit and scope of the embodiments. Elements of systems, devices, apparatus, and methods shown with any embodiment are exemplary for the specific embodiment and can be used in combination or otherwise on other embodiments within this disclosure. For example, the steps of any methods depicted in the figures or described in this disclosure do not require the particular order or sequential order shown or described to achieve the desired results. In addition, other steps or operations can be provided, or steps or operations can be eliminated or omitted from the described methods or processes to achieve the desired results. Moreover, any components or parts of any apparatus or systems described in this disclosure or depicted in the figures can be removed, eliminated, or omitted to achieve the desired results. In addition, certain components or parts of the systems, devices, or apparatus shown or described herein have been omitted for the sake of succinctness and clarity.

[0158] Accordingly, other embodiments are within the scope of the following claims and the specification and / or drawings can be regarded in an illustrative rather than a restrictive sense.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W

[0159] Each of the individual variations or embodiments described and illustrated herein has discrete components and features which can be readily separated from or combined with the features or any of the other variations or embodiments. Modifications can be made to adapt a particular situation, material, composition or matter, process, process act(s) or step(s) to the objective(s), spirit, or scope of the present invention.

[0160] Methods recited herein can be carried out in any order of the recited events that is logically possible, as well as the recited order of events. Moreover, additional steps or operations can be provided or steps or operations can be eliminated to achieve the desired result.

[0161] Furthermore, where a range of values is provided, every intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, any optional feature of the inventive variations described can be set forth and claimed independently, or in combination with any one or more of the features described herein. For example, a description of a range from 1 to 5 should be considered to have disclosed subranges such as from 1 to 3, from 1 to 4, from 2 to 4, from 2 to 5, from 3 to 5, etc. as well as individual numbers within that range, for example 1.5, 2.5, etc. and any whole or partial increments therebetween.

[0162] All existing subject matter mentioned herein (e.g., publications, patents, patent applications) is incorporated by reference herein in its entirety except insofar as the subject matter can conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.

[0163] Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms "a, an," "said" and "the" include plural referents unless the context clearly dictates otherwise. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or use or a "negative" limitation. Unless defined otherwise, all technical and scientific terms used hereinPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Whave the same meaning as commonly understood by one or ordinary skill in the art to which this invention belongs.

[0164] Reference to the phrase "at least one of, when such phrase modifies a plurality or items or components (or an enumerated list or items or components) means any combination or one or more or those items or components. For example, the phrase "at least one or A, B, and C" means: (i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; or (vii) A and C.

[0165] In understanding the scope of the present disclosure, the term "comprising" and its derivatives, as used herein, are intended to be open-ended terms that specify the presence of the stated features, elements, components, groups, integers, and / or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and / or steps. The foregoing also applies to words having similar meanings such as the terms, "including", "having" and their derivatives. Also, the terms "part, section," "portion," "member" "element," or "component" when used in the singular can have the dual meaning of a single part or a plurality of parts. As used herein, the following directional terms "forward, rearward, above, downward, vertical, horizontal, below, transverse, laterally, and vertically" as well as any other similar directional terms refer to those positions of a device or piece of equipment or those directions of the device or piece of equipment being translated or moved.

[0166] Finally, terms or degree such as "substantially", "about" and "approximately" as used herein mean the specified value or the specified value and a reasonable amount of deviation from the specified value (e.g., a deviation of up to 1%, %, ±5%, or ±10%, as such variations are appropriate) such that the end result is not significantly or materially changed. For example, "about 1.0 cm" can be interpreted to mean " 1.0 cm" or between "0.9 cm and 1.1 cm." When terms of degree such as "about" or "approximately" are used to refer to numbers or values that are part of a range, the term can be used to modify both the minimum and maximum numbers or values.

[0167] It will be understood by one of ordinary skill in the art that the various methods disclosed herein can be embodied in a non-transitory readable medium, machine-readable medium, and / or a machine accessible medium comprising instructions compatible, readable, and / or executable by a processor or server processor of a machine, device, or computing device. The structures and modules in the figures can be shown as distinct and communicating with only a few specific structures and not others. The structures can be merged with eachPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wother, can perform overlapping functions, and can communicate with other structures not shown to be connected in the figures. Accordingly, the specification and / or drawings can be regarded in an illustrative rather than a restrictive sense.

[0168] This disclosure is not intended to be limited to the scope of the particular forms set forth, but is intended to cover alternatives, modifications, and equivalents or the variations or embodiments described herein. Further, the scope of the disclosure fully encompasses other variations or embodiments that can become obvious to those skilled in the art in view of this disclosure.

[0169] What is claimed is:

Claims

Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-WCLAIMS1. A surgical device comprising:a handle, including a lever operatively coupled to an actuation line;an elongated shaft operatively coupled the handle, the actuation line extending along the elongated shaft;an end effector operatively coupled to the elongated shaft, opposite the handle, the end effector operatively coupled to the actuation line; andat least one of an articulation plate and a ball-and-socket joint interposing at least two of the handle, the elongated shaft, and the end effector, where at least one of the articulation plate and the ball-and-socket joint is operatively coupled to control lines operatively coupled to a joystick of the handle, where the joystick of the handle is repositionable to control yaw and pitch changes between at least two of the handle, the elongated shaft, and the end effector.

2. The surgical device of claim 2, wherein the end effector includes a pair of repositionable jaws removably coupled to an exclusion clip, the pair of repositionable jaws operatively coupled to the actuation line so that repositioning the actuation line repositions the pair of repositionable jaws and the exclusion clip when removably coupled thereto.

3. The surgical device of claim 2, wherein the exclusion clip is enclosed and circumscribed entirely by a fabric cover.

4. The surgical device of claim 1, wherein the handle includes a depressible button operatively coupled to a release line, where the release line is spring biased to removably couple an exclusion clip from a pair of jaws of the end effector when the depressible button is depressed.

5. The surgical device of claim 1, wherein the end effector includes a linkage repositionable between an expanded position and a contracted position, the linkage operatively coupled to a pair of jaws that are removably coupled to an exclusion clip.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W6. The surgical device of claim 1, wherein at least one of the control lines is tensioned using a tension screw.

7. The surgical device of claim 1, wherein the handle is configured to allow single hand control over a first control that is configured to cause repositioning of the end effector, a second control for disengaging an exclusion clip from the end effector, and a third control to at least one of open and close the exclusion clip while engaging the end effector.

8. The surgical device of claim 1, wherein:the end effector includes a first jaw and a second jaw, with at least one of the first jaw and the second jaw being repositionable to vary a spacing therebetween;the first jaw is removably coupled to a first beam of the exclusion clip;the second jaw is removably coupled to a second beam of the exclusion clip; the exclusion clip is repositionable between an open position and a closed position; andthe exclusion clip lies flat in both the open position and the closed position.

9. The surgical device of claim 1, wherein:the ball-and-socket joint interposes at least two of the handle, the elongated shaft, and the end effector;the ball-and-socket joint includes a first ball-and-socket joint operatively coupling the handle to the elongated shaft; andthe ball-and-socket joint includes a second ball-and-socket joint operatively coupling the elongated shaft to the end effector.

10. A method of using a surgical device of occlude a left atrial appendage, the method comprising:delivering an exclusion clip, removably coupled to an end effector of a surgical device, proximate a left atrial appendage, the surgical device including a handle controller operatively coupled to an elongated shaft, which is operatively coupled to the end effector;thumb controlling a joystick of the handle controller to vary pitch and yaw between at least two of the handle controller, the elongated shaft, and the end effector in order toPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wreposition opposed beams of the exclusion clip so that a base of the left atrial appendage interposes the opposed beams;removing the exclusion clip from the end effector while the base of the left atrial appendage interposes the opposed beams; andrepositioning the surgical device so that the end effector is no longer proximate the left atrial appendage but the exclusion clip is.

11. The method of claim 10, wherein:the joystick is operatively coupled to at least one of an articulation plate and a ball-and-socket joint; andthumb controlling the joystick of the handle controller includes repositioning a plurality of control lines coupled to at least one of the articulation plate and the ball-and-socket joint, and concurrently operatively coupled to at least one of the handle controller, the elongated shaft, and the end effector.

12. The method of claim 10, wherein:the exclusion clip is enclosed;the exclusion clip circumscribes the left atrial appendage when the base of the left atrial appendage interposes the opposed beams;the exclusion clip is covered in a fabric; andthe fabric circumscribes the left atrial appendage when the base of the left atrial appendage interposes the opposed beams.

13. The method of claim 10, wherein removing the exclusion clip from the end effector includes depressing a release of the handle controller to automatically retract a retention line extending between the handle controller and the end effector.

14. The method of claim 10, wherein thumb controlling the joystick of the handle controller includes repositioning the joystick while the joystick is unlocked via a lock of the handle controller.Patent Cooperation Treaty ApplicationDocket No. ATR04-MN534-W15. The method of claim 10, wherein thumb controlling the joystick of the handle controller includes varying both the yaw and pitch of the end effector with respect to the elongated shaft.

16. The method of claim 10, wherein thumb controlling the joystick of the handle controller includes varying both the yaw and pitch of the elongated shaft with respect to the handle controller.

17. A method of fabricating a surgical device, the method comprising:operatively coupling a handle controller to an elongated shaft;operatively coupling an end effector to the elongated shaft;removably coupling an exclusion clip to the end effector;using at least one of an articulation plate and a ball-and-socket joint to interpose at least two of the handle controller, the elongated shaft, and the end effector; and operatively coupling a thumb control of the handle controller with at least one of the articulation plate and the ball-and-socket joint, where the thumb control is repositionable front-to-back and side-to-side.

18. The method of claim 17, wherein:the end effector includes a first jaw repositionable with respect to a second jaw; removably coupling the exclusion clip to the end effector includes removably mounting a first beam of the exclusion clip to the first jaw, and removably mounting a second beam of the exclusion clip to the second jaw; andthe method further comprises operatively coupling actuation of a button or trigger associated with the handle controller with a first disengagement link interposing the first beam and the first jaw, and a second disengagement link interposing the second beam and the second jaw.

19. The method of claim 18, further comprising:providing a plurality of cables extending from at least one of the articulation plate and the ball-and-socket joint, where at least one of the plurality of cables is operatively coupled to a tension screw; andPatent Cooperation Treaty ApplicationDocket No. ATR04-MN534-Wrotating the tension screw to tension at least one of the plurality of cables operatively coupled thereto.

20. The method of claim 18, further comprising:assembling the handle controller so that the handle controller can be gripped and retained in place using a single hand, where the handle controller includes at least three operative controls comprising:the thumb control configured to control yaw and pitch between at least two of the handle controller, the elongated shaft, and the end effector, the thumb control configured to be manipulated by a thumb (digit 1) of the single hand,an exclusion clip disengagement control configured to selectively disengage the exclusion clip from the end effector and to be manipulated by an index finger (digit 2) of the single hand, andan exclusion clip opening / closing control configured to selectively open / close the exclusion clip when coupled to the end effector and to be manipulated by at least one of a middle finger (digit 3), a ring finger (digit 4), and a little finger (digit 5) of the single hand.

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