Devices and methods for occluding left atrial appendage

Abstract

Systems and methods for applying occlusion clips are disclosed herein. A medical device may include a handle and an elongate shaft extending from the handle, the elongate shaft including a proximal end, a distal end, and a central lumen. The medical device may also include an end effector at the distal end of the elongate shaft, the end effector including a first jaw and a second jaw configured to engage with and deliver the occlusion clip to target tissue, where the end effector includes a linkage mechanism configured to couple the occlusion clip to the target tissue. The linkage mechanism is configured to move the first jaw and the second jaw relative to each other. The medical device may also include a plurality of cables extending through the central lumen. The medical device may also include an articulation plate coupled to the handle. The medical device may also include an articulation joint coupling the articulation plate and the elongate shaft.

Description

Devices and methods for occluding the left atrial appendage Technical Field

[0001] This application is a non-provisional application of U.S. Provisional Application No. 63 / 520,270, filed on August 17, 2023, the entire contents of which are incorporated herein by reference.

[0002] This disclosure generally relates to the field of left atrial appendage closure, and more specifically, to the closure of the left atrial appendage using an occlusion device. Background Technology Background

[0003] Current methods for left atrial appendage closure typically involve using a scalpel, gripper, and needle actuator to remove the appendage and suture the remaining wound. Such devices are more versatile and can be used in a variety of surgical procedures. However, they may require more operator training and a higher level of skill to operate.

[0004] Furthermore, current devices are often limited by their diameter, thus restricting every aspect of the device. For example, some current devices can only be introduced via a 12mm cannula. This limitation can result in additional overall procedure time.

[0005] Therefore, methods and devices for occluding the left atrial appendage are still needed, which are intuitive to use and minimize confusion. Devices that can be assembled via a small cannula are also required. Summary of the Invention

[0006] This document discloses a medical device for applying an occlusion clamp. The medical device may include a handle and an elongated shaft extending from the handle, the elongated shaft including a proximal end, a distal end, and a central lumen. The medical device may further include an end effector at the distal end of the elongated shaft, the end effector including a first jaw and a second jaw configured to engage the occlusion clamp and deliver the occlusion clamp to target tissue, wherein the end effector includes a linkage mechanism configured to move the first jaw and the second jaw relative to each other. The medical device may further include multiple cables extending through the central lumen. The medical device may further include an articulated plate coupled to the handle, wherein the articulated plate includes a central opening and a plurality of peripheral openings, each of the plurality of peripheral openings receiving a screw, wherein each screw receives one of the plurality of cables for tensioning the linkage mechanism. The medical device may further include an articulated joint connecting the articulated plate and the elongated shaft, the articulated joint being configured to allow rotational movement between the handle and the elongated shaft.

[0007] The articulated joint can be a ball-and-socket joint. The device may also include an O-ring configured to engage with the ball-and-socket joint and the articulated plate to lock the ball-and-socket joint, thereby preventing articulation of the end effector. Multiple peripheral openings may include a D-shaped cross-section.

[0008] Each screw may include a through-hole, wherein the through-hole includes a first through-hole diameter and a second through-hole diameter, wherein the first through-hole diameter is smaller than the second through-hole diameter. A first ball and a second ball may be coupled to each of a plurality of cables, wherein the first ball includes a first ball diameter smaller than the first through-hole diameter, and wherein the second ball includes a second ball diameter larger than the first through-hole diameter, wherein pulling the cable distally pulls the first ball through the through-hole and traps the second ball to tension the cable. The first ball may be coupled to a ball-and-socket connector within an end effector.

[0009] The cable can be crimped with screws to restrict axial movement. The end effector may also include a ball joint. The ball joint may include multiple openings to which multiple cables are connected. The ball of the ball joint may include a slot, and the socket of the ball joint includes a pin, wherein the slot and the pin are engaged to prevent circumferential rotation of the ball joint.

[0010] The linkage mechanism may include multiple linkage bars connected to the first jaw and the second jaw, wherein the multiple linkage bars transmit force from multiple cables to the first jaw and the second jaw. The multiple cables may each consist of multiple wires.

[0011] In other variations, this document discloses a system for the left atrial appendage of a patient with occlusion. The system may include a handle, an elongated shaft extending from the handle, the elongated shaft including a proximal end, a distal end, and a central lumen extending along a longitudinal axis of the elongated shaft. The system may also include an end effector located at the distal end of the elongated shaft, the end effector including a first jaw and a second jaw configured to engage an occlusion clamp and deliver the occlusion clamp to target tissue, wherein the end effector includes a linkage mechanism configured to move the first jaw and the second jaw relative to each other. The system may also include multiple cables extending through the central lumen. The system may also include an articulated plate coupled to the handle. The system may further include an articulated joint connecting the articulated plate and the shaft, the articulated joint being configured to allow rotational movement between the handle and the elongated shaft. The handle may include a lever portion configured to rotate in a first plane perpendicular to the longitudinal axis, wherein the lever portion is configured to rotate in a second plane perpendicular to the first plane, wherein rotation of the lever portion in the first plane causes the end effector to move in a yaw direction, and rotation of the lever portion in the second plane causes the end effector to move in a pitch direction.

[0012] The handle may also include a gripping portion configured for gripping by an operator with one or more fingers, wherein an articulated plate is located between the gripping portion and the lever portion. The lever portion is rotatable by 45 degrees in a first plane in a first direction and by 45 degrees in a second direction, wherein the lever portion is rotatable by 45 degrees in the second plane in the first direction and by 45 degrees in the second direction. The handle may also include a thumb portion extending from the lever portion, wherein the thumb portion extends at a 45-degree angle to the longitudinal axis of the elongated shaft.

[0013] In another variation, the medical device may include a handle and an elongated shaft extending from the handle, the elongated shaft including a proximal end, a distal end, and a central lumen. The medical device may also include an end effector located at the distal end of the elongated shaft, the end effector including a first jaw and a second jaw configured to engage an occlusion clamp and deliver the occlusion clamp to target tissue. The medical device may also include multiple cables extending through the central lumen. The medical device may also include an articulated plate coupled to the handle, wherein the articulated plate includes a central opening and a plurality of peripheral openings, each of the plurality of peripheral openings receiving a screw. The medical device may also include an articulated joint connecting the articulated plate and the elongated shaft, the articulated joint being configured to allow rotational movement between the handle and the elongated shaft. The medical device may also include an articulated locking system within the handle, wherein the articulated locking system includes a ring configured to engage the articulated joint and the articulated plate such that the articulated joint and the articulated plate are locked, thereby locking the end effector.

[0014] The joint movement locking system may also include a brake actuator plate, wherein the brake actuator plate is configured to release the ring from engagement with the joint movement joint and the joint movement plate when the occluder clamp is released. An elastic member may be coupled to the brake actuator plate. Attached Figure Description

[0015] Figure 1 shows a side view of a device for applying clamps to occlude the left atrial appendage.

[0016] Figure 2A shows a variation of the tensioning screw used in conjunction with a joint plate.

[0017] Figure 2B illustrates a variation of the screw assembly and a corresponding method for tensioning the peripheral cable.

[0018] Figure 2C shows another variation of the screw assembly and the corresponding method for tensioning the peripheral cable.

[0019] Figure 2D shows another variation of the screw assembly and a corresponding method for tensioning the peripheral cable, wherein the screw also includes a crimping element surrounding the cable.

[0020] Figure 3A shows a variation of the handle according to the present invention.

[0021] Figure 3B shows a front view of an articulated plate that includes a central opening and peripheral openings surrounding the central opening.

[0022] Figure 3C shows a schematic diagram of the thumb portion relative to the longitudinal axis of the elongated shaft 106.

[0023] Figures 3D and 3E show a modified view of the handle held by the user.

[0024] Figure 4 shows a joint movement lock designed to fix the end effector according to the user's needs.

[0025] Figures 5A and 5B show the distal ball joint that enables the end effector to perform pitch and yaw in one position.

[0026] Figure 6 shows a handle according to another variation of the device.

[0027] Figures 7A to 7E show the end effectors in various positions during use.

[0028] Figure 8 shows another variation of the device that provides rotation to the end effector. Detailed description of the specific implementation method

[0029] Figure 1 illustrates a medical device 100 for applying an occlusion clamp to occlude the left atrial appendage. The device 100 may include an end effector 102, an articulated plate 104, and an elongated shaft 106. The articulated plate 104 is coupled to a handle (not shown), and the elongated shaft 106 includes a longitudinal axis and a central lumen 600 extending between the end effector 102 and the articulated plate 104 (see Figure 6).

[0030] The end effector 102 may include a first jaw 108, a second jaw 110, and a linkage mechanism 112 connecting the jaws 108, 110 to a base portion 114. A plurality of pins 116 may be used to connect various portions of the linkage mechanism 112. The first jaw 108 and the second jaw 110 may extend from the linkage mechanism 112 and may be movable relative to each other to deliver a clamp 118 around the left atrial appendage. Reference is made to the commonly owned U.S. Patent No. 9,861,371, the entire contents of which are incorporated herein by reference.

[0031] However, it should be understood that the end effector 102 can be used to apply clamps to other target tissues or target areas of the anatomical structure. As will be described below, the linkage mechanism 112 may include a plurality of linkages configured to switch jaws 108, 110 between a first compact configuration and a second extended configuration (as seen in Figures 7A-7E).

[0032] The end effector 102 can be configured to fit into a conventional port or cannula of approximately 5 mm to 7 mm (e.g., approximately 5.9 mm) commonly used in minimally invasive thoracic surgeries. This diameter of port or cannula is crucial for reducing patient pain because the passageway between the ribs is tight and includes nearby nerves. Therefore, the elongated shaft 106 may include a diameter of approximately 5 mm to approximately 7 mm to accommodate insertion through the cannula and allow for bending where necessary.

[0033] The end effector 102 in the first compact configuration (see FIG. 7A) may have a diameter of approximately 5.84 mm. The end effector 102 may be configured to open a clamping dimension of approximately 20 mm in the second extended configuration (see FIG. 7C) so as to open the interior of the clamping device to approximately 14 mm.

[0034] The elongated shaft 106 may include multiple clamping opening cables 120 within a central lumen. A central cable 307 may extend through a central opening in the articulated plate 104 (see FIG. 3B) and into a handle, such that the handle can control the movement of the first jaw 108 and the second jaw 110 relative to each other, as will be described below.

[0035] Multiple peripheral cables 120 may exit the elongated shaft 106 at its proximal end and enter one or more peripheral openings 122 of the articulated plate 104. Cables 120, 307 may thus extend from the linkage 112 to corresponding portions of the cable 120, 307 in the handle and may be used to control the end effector 102 via the handle. For example, peripheral cables 120 may be used to articulate the end effector 102 relative to the central plane of the device 100 in both pitch and yaw directions.

[0036] The articulated plate 104 and the elongated shaft 106 may include a proximal ball joint 124 therebetween. The ball of the proximal ball joint 124 may include an opening through the center to allow openings and multiple cables to pass through and mate with control elements in the handle. The proximal ball joint 124 may accordingly allow rotation between the handle and the elongated shaft 106.

[0037] Multiple peripheral cables 120 can exit the articulation plate 104 and reach the handle through multiple screws 128 placed in the peripheral opening 122 of the articulation plate 104.

[0038] The end effector 102 and the elongated shaft 106 may include a distal ball joint 130 between them. The distal ball joint 130 is articulated via a handle to rotate the end effector as needed. When this movement is no longer required, the distal ball joint 130 can be locked by the handle. The distal ball joint 130 is positioned as close as possible to the end effector 102 to minimize dead space, allowing the end effector 102 to provide articulation within the limited space between the cannula and the left atrial appendage.

[0039] The distal ball-and-socket connector 130 can be compact to operate within the limited space between the end of the cannula and the left atrial appendage. Therefore, the distal ball-and-socket connector 130 can be fitted into a cannula with a diameter of approximately 5 mm. The rigidity of the distal ball-and-socket connector 130 can be optimized so that the clamp can be pushed to the base of the atrial appendage during use.

[0040] Each of cables 120 and 307 (center or perimeter cables) may include a 1×7 wire construction (e.g., seven wires in a bundle); however, other cable constructions may be used. Cables 120 and 307 may include a diameter of approximately 0.016 inches. Cables 120 and 307 may include a minimum breaking strength of approximately 30 lbs. Cables 120 and 307 may be made of stainless steel, but other materials (e.g., aluminum, copper, titanium, tungsten, etc.) may be used.

[0041] In other variations, cables 120 and 307 may include various wire constructions that can vary in strength and flexibility. In some variations, cables 120 and 307 may include 1×19 wires (e.g., nineteen wires in a bundle).

[0042] In other variations, cables 120 and 307 may comprise multiple cables made of multiple wires. For example, cables 120 and 307 may comprise a 3×7 configuration (21 wires in total), a 7×7 configuration (49 wires in total), a 7×19 configuration (133 wires in total), or a 7×49 configuration (343 wires in total).

[0043] Figure 2A shows a variation of the tension screw 128 used in conjunction with the articulated plate 104. The tension screw 128 may include an opening 200 therethrough. The opening 200 may accommodate a peripheral cable 120, thereby controlling the tension of the peripheral cable 120 for articulation of the end effector 102.

[0044] One technical problem encountered by the applicant is that the current device is constructed from the bottom up, thus limiting the channel for tensioning the cable to the top side. Manufacturing devices using a complex series of pulleys and weights are typically used to set the tension. The force from the cable tension dissipates in the handle, which is not fully fixed until the final ultrasonic welding step. This results in variations in tension, and therefore inconsistent joint movement. One technical solution discovered by the applicant is to tension the peripheral cables 120 so that they are tight enough to maintain the rigidity of the end effector 102. Simultaneously, the peripheral cables should have some slack to reduce friction within the device 100, allowing the end effector 102 to still articulate. Therefore, for ease of manufacture and to set the tension of the device 100 to the desired level, the screw assembly can be tensioned and aligned as a unit before assembly into the handle. Such a method is described below with reference to Figures 2B to 2D.

[0045] Figure 2B illustrates a variation of the screw assembly and a corresponding method for tensioning the peripheral cable 120. This variation includes a screw with an opening 200 comprising two inner diameters. In this variation, the peripheral cable 120 may be pre-formed approximately to its functional length to eliminate termination steps during manufacturing. The peripheral cable 120 may include a distal ball 202 with a diameter of approximately 0.03 inches and a proximal ball 204 with a diameter of approximately 0.06 inches. The screw 128 may include an opening 200 with two inner diameters: a first through-hole 206 and a second through-hole 208, the second through-hole 208 comprising a diameter larger than that of the first through-hole 206. The distal ball 202 may pass through the screw 128, while the proximal ball 204 is countersunk (i.e., the opening 200 changes its diameter). The distal ball 202 is then fed through an elongated shaft 106 and attached to a distal ball-and-socket connector 130. It should be understood that multiple peripheral cables 120 may include the same length because the articulation function of device 100 occurs in the same plane.

[0046] Screw 128 may have anti-rotation features, such as a flat portion, to prevent it from rotating when the cable is tensioned. Screw 128 can be fitted through a D-shaped cross-sectional peripheral opening 200 in the articulated plate 104, and tension can be set using nuts on opposite sides of the articulated plate 104. Tension can be set by counting the additional turns on the nuts when screw 128 is aligned. This allows for rapid modification of various tensions during development to determine the optimal user feel.

[0047] Figure 2C illustrates another variation of the screw 128 assembly and a corresponding method for tensioning the peripheral cable, wherein the screw 128 includes an opening 200 in which the peripheral cable 120 cannot move. During manufacturing, the screw 128 can be crimped to axially lock the cable in its position.

[0048] Figure 2D illustrates another variation of the screw 128 assembly and a corresponding method for tensioning the peripheral cable, wherein the screw 128 further includes a crimping element 210 surrounding the peripheral cable 120. When the appropriate tension is achieved, this positions the peripheral cable 120 so that it cannot move axially.

[0049] One technical challenge the applicant encountered was maintaining the rigidity of the end effector 102 while still providing articulation. One technical solution the applicant found was to increase the preload on the peripheral cable 120. For example, if the articulation cable is not preloaded, a force of 10 pounds of tension on the end effector will stretch the cable by approximately 0.05 inches, resulting in considerable end effector recoil. However, if the cable has an initial tension of 10 pounds, the same load will not cause the end effector to deflect at all. Friction between the proximal ball joints 124 can also contribute to the rigidity of the end effector.

[0050] Figure 3A illustrates a variation of the handle 300 according to the invention. The handle 300 extends from the articulated plate 104 and is capable of including a lever portion 302 and a thumb portion 304. The lever portion 302 can be configured to rotate in a first plane (e.g., the y-plane) perpendicular to the longitudinal axis of the elongated shaft 106 to move the end effector in the yaw direction. The lever portion 302 can be configured to rotate in a second plane (e.g., the z-plane) perpendicular to the first plane to move the end effector in the pitch direction.

[0051] Figure 3B shows a front view of the articulated plate 104, which includes a central opening 306 and a peripheral opening 122 surrounding the central opening 306. The central opening 306 can accommodate and mount a ball from the proximal ball joint 124. A central cable 307 can enter and exit the opening of the ball to mate with their control elements in the handle 300, thereby opening and closing the jaws 108, 110 of the end effector 102.

[0052] The peripheral cable 120 in the articulated plate 104 can be positioned further away from the center than the peripheral cable 120 at the distal end near the end effector 102 (e.g., at the distal ball joint 130). Therefore, less angular movement in the articulated plate 104 can result in more movement at the end effector 102. For example, 10 degrees of articulation at the articulated plate 104 can be greater than 20 degrees at the distal ball joint 130.

[0053] The articulated plate 104 may include a circular protrusion on the opposite side of the central opening 306, which can be fitted between the halves of the handle to constrain the articulated plate 104. Therefore, the articulated plate 104 can rotate laterally to provide yaw direction control (right and left). Torque force can be achieved via a lever portion 302 and a thumb portion 304 located approximately 1 inch from the proximal ball joint. When the lever portion 302 moves axially relative to the elongated shaft 106, the end effector 102 can move in the pitch direction (up and down). For example, pushing the lever forward can move the end effector downward relative to the longitudinal axis. Similarly, when the thumb portion 304 is pushed to the left (relative to the operator's viewpoint), yaw control can move the end effector 102 to the left to keep the cable forces collinear. In some variations, the articulation of the peripheral cable 120 can be reversed to change the direction of articulation at the distal end of the device 100.

[0054] Figure 3C illustrates a variation in which the thumb portion is positioned at a 45-degree angle in front of the articulated plate 104. The thumb portion 304 may extend approximately 45 degrees from the longitudinal axis of the elongated shaft 106, allowing the thumb portion 304 to share the pitch and yaw movements of the end effector 102 with approximately the same force and distance (see, for example, Figure 3C). This allows a 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).

[0055] Figures 3D and 3E illustrate a handle 300, including controls using a thumb portion 304 and a finger portion 308. The finger portion 308 can be used to increase the force of control over the thumb portion 304, thereby improving the ergonomics of the handle 300 for the user 310. The thumb portion 304 in Figure 3D may be a bulb-shaped design. The thumb portion 304 in Figure 3E may include a concentric ring design to facilitate omnidirectional function of the thumb portion 304 in potentially wet environments. The handle 300 may also include a clamp opening control 312 that actuates jaws 108, 110 relative to each other.

[0056] For ergonomic purposes, the handle 300 can be designed such that the articulated plate 104 is collinear with the carpal joint in the user's thumb, which is located near the wrist. The carpal joint is also a ball joint, and therefore, aligning it with the proximal ball-and-socket joint 124 mechanism in the handle 300 minimizes unwanted relative movement between the user's thumb and the lever portion 302.

[0057] Figure 4 illustrates a joint locking system 400 (or braking system) designed to secure the end effector 102 as needed by the user. When movement of the end effector 102 is no longer required, the proximal ball joint 124 can be locked. The joint locking system 400 may be located within the handle 300 and may employ a high-friction elastomer O-ring 402 that presses against the proximal ball joint 124 to prevent the end effector 102 from reverse-drive when force is applied to the clamp at the distal end of the device 100.

[0058] As shown in Figure 4, the O-ring 402 can be positioned around the ball 404 and within a wedge-shaped opening between the articulated plate 104 and the proximal ball 404, allowing a relatively small force to push the O-ring 402 into the opening, where the force is effectively amplified. When the O-ring 126 engages the wedge-shaped opening between the articulated plate 104 and the proximal ball 404, the proximal ball-and-socket joint 124 can be locked without rotating relative to the articulated plate 104. As the articulated plate 104 attempts to move, the resulting friction further tightens the O-ring 402, increasing the holding force. When the O-ring 402 is in this position, the end effector 102 can be locked.

[0059] The brake actuator plate 406 can be connected to the resilient clamp release spring 408 via cable 410, such that when the clamp is released, the lock disengages, making it easy to remove the end actuator 102 from the device 100.

[0060] The joint locking system 400 is designed to sufficiently increase friction to stabilize the end effector 102. When in the locked position, the end effector 102 can still be repositioned by the user by applying additional force. A cam-type mechanism (not shown) retracts the brake actuator plate 406, causing the O-ring 402 to disengage from the slot, thereby allowing the lever portion 302 of the handle 300 to move with minimal force.

[0061] In some variations, in order to eliminate control from the device, friction and / or force applied by the operator can be used to hold the end effector 102 in the desired position.

[0062] In some variations, the O-ring 402 may be connected to the spring 408 for clamp deployment, so that the O-ring 402 will disengage when the clamp 118 is deployed. This ensures that the end effector 102 is removable (i.e., not locked in place), allowing the end effector 102 to be pulled straight during removal from the cannula. The O-ring 402 may engage a rigid component, such as the proximal ball joint 124 in the handle 300.

[0063] Figures 5A and 5B illustrate the distal ball-and-socket connector 130 that enables the end effector 102 to perform pitch and yaw in one position. This can reduce the total dead space on the pivot section of the end effector 102 by approximately 0.375 inches, which can be helpful because the distance between the distal end of the auricle and the cannula may be limited, especially in smaller patients.

[0064] The distal ball 500 may include a cable slot 502 to which the peripheral cable 120 is connected. The cable slot 502 serves as a channel for the peripheral cable 120, widening proportionally in the equatorial and southern hemisphere regions, so that off-center joint movement does not alter the cable tension. In some variations, the length of the peripheral cable 120 remains unchanged during pivoting of the end effector 102 to maintain a constant joint movement force.

[0065] The slot 504 on the ball and the pin (not shown) at the equator of the socket prevent the distal ball 500 from rotating circumferentially. The peripheral cables 120 can always be kept taut, so that they hold the distal ball socket 130 together.

[0066] Since the tension of the peripheral cable 120 can be high, it is important to minimize the friction between the distal ball 500 and the socket 506. Therefore, the socket 506 can be made of materials such as nylon or polyetherimide to reduce friction and provide sufficient strength. Additionally, the surface finish and fit between the proximal ball 404 and the socket 506 can affect the frictional forces used for joint movement.

[0067] In some variations, a hypotube can be crimped onto the outside of the peripheral cable 120 to help maintain end effector rigidity, thereby compensating for increased cable load and subsequent cable stretching. In some variations, tungsten alloy cable can be used to increase the strength of the peripheral cable 120 by approximately 30%, while also increasing cable flexibility.

[0068] Figure 6 shows a handle 300 according to another variation of the device 100. The handle 300 may include an articulated lever 602 and a clamp opening lever 604. The handle may be positioned at the proximal end of the elongated shaft. An end actuator (not shown) may be positioned at the distal end of the elongated shaft 106.

[0069] The articulated lever 602 can be positioned at the top of the handle 300, allowing the user to control the articulated lever 602 with their thumb while holding the handle 300 with one hand. The articulated lever 602 can be configured such that the movement of the lever corresponds to the end effector for intuitive operation by the user.

[0070] The clamp opening lever 604 may include an annular shape on the underside of the handle 300, allowing the user to control the clamp opening lever 604 with one finger while holding the handle 300 with one hand. The clamp opening lever 604 provides control to open and close the clamp without requiring considerable force from the user.

[0071] In some variations, the clamp opening lever 604 can be a momentary control element, such that the end effector 102 moves only when the clamp opening lever 604 is pressed down. The opening 200 in the clamp opening lever 604 can be used for an opening function, allowing the user's other fingers to be used to lock the lever. The clamp opening lever 604 can also be a switch lock.

[0072] The clamp opening lever 604 can transmit up to approximately 10 pounds of force to the clamp opening center cable 307 over a distance of approximately 0.375 inches. The stroke of the clamp opening lever 604 can be a specified length, allowing sufficient mechanical benefit to be achieved using the lever mechanism. The mechanical benefit can be a result of the stroke length and the force applied to the clamp opening lever 604. The force applied to the clamp opening lever 604 can be reduced proportionally to the travel distance.

[0073] The clamp opening function can be achieved using only the index finger, as the ergonomics of the handle 300 allow for this. The index finger can hook onto the opening lever ring and provide a better grip on the device 100. In some variations, a 1-inch pull can provide a 3:1 force reduction, and therefore, the pull required to open the clamp can be approximately 3 to 4 pounds.

[0074] The clamp release mechanism can provide tactile and auditable feedback to ensure that the clamp has been actively released. In some variations, the clamp release mechanism can be a button on the clamp opening lever 604.

[0075] A single control point can move the end effector 102 and allow simultaneous movement. Because joint movement control is simplified and can be performed simultaneously with the clamp opening lever 604, in some variations, a separate lock for joint movement may not be necessary.

[0076] In some variations, the clamp opening lever 604 may have a locking mechanism in the open position. To eliminate the need for a separate button, the clamp opening lever 604 may be locked when the clamp is open and released when the clamp opening lever 604 is pressed a second time.

[0077] Figures 7A through 7E illustrate the end effector 102 in various positions during use. The end effector 102 may include one or more proximal linkages 700 and one or more distal linkages 702, which are connected to each other and form openings to receive the clamp 118 via jaws 108, 110. One or more linkages 700, 702 may pivot relative to each other on one or more pins 116. The pins 116 may have a diameter of approximately 0.03 inches and may be configured to minimize frictional losses. Figure 7A shows a first compact configuration, and Figure 7C shows a second extended configuration.

[0078] Two jaws 108 and 110 can be positioned at the ends of linkages 700 and 702. The clamps attached to jaws 108 and 110 can be substantially parallel to the longitudinal axis of the elongated shaft 106.

[0079] One or more linkages 700, 702 can actuate an opening linkage mechanism that transmits vertical force from the center cable 307 to the clamp attachment jaws 108, 110, as shown in Figures 7D and 7E. The center cable 307 can pass through a cavity in the shaft and can be connected to one or more linkages 700, 702. The center cable 307 may include a diameter of approximately 0.016 inches and may be wound around the opening linkage pin 116.

[0080] The end effector 102 can be configured to pass through a cannula needle with a diameter of about 5 mm, and can take advantage of the fact that the cannula needle is slightly larger than its nominal description.

[0081] The end effector 102 can open the clamp to an opening of approximately 14 mm. The clamp and the end effector 102 can articulate 30° with respect to the center plane in pitch (e.g., up and down) and yaw (e.g., left and right).

[0082] Each cable 307 can be fitted into approximately 0.02 inches of space provided between the centers of linkages 700 and 702. Cable 307 can be rigid, such that cable 307 is held on pivot pin 116. Cable 307 may include approximately 0.016 inches in diameter.

[0083] In some variations, cable 307 may include a pre-formed "U"-shaped bend, allowing cable 307 to lap over pivot pin 116 in end effector 102. This configuration can double the cable strength to reduce strain and allow end effector 102 to have a sufficient safety factor. Using tungsten alloy wire can further improve the safety factor.

[0084] The two free ends of the cable can be attached to the clamp opening lever 604 in the handle 300. Because the pre-formed "U"-shaped ends of the cable can constrain the pivot pin 116, the end actuator 102 can open symmetrically. In some variations, the cable 307 can also be mechanically attached to the pivot pin 116 or a proximal linkage. The load required to open the clamp can be less than 10 pounds, and therefore, conventional cables can be used in some variations.

[0085] Figure 8 illustrates another variation of the device 100 that provides rotation to the end effector 102. The device 100 may include a rotating cone 800 having one or more grooves 802 positioned thereon to improve ergonomics. The rotating cone 800 may be positioned on an elongated shaft 106 such that when the user rotates the rotating cone 800, the elongated shaft 106 rotates. Therefore, the end effector 102 rotates as the center cable 307 within the elongated shaft 106 twists to accommodate the rotation. The rotation of the end effector 102 may be limited to approximately 180 degrees to prevent sticking. The significant tension on the center cable 307 naturally provides resistance to prevent the elongated shaft 106 from rotating too freely. If a greater rotational locking force is required, friction can be increased by using a material with higher friction or by incorporating surface interlocking features to ensure a more secure positioning.

[0086] The distal linkage 702 and proximal linkage 700 can be in a compressed state, allowing them to withstand buckling loads. The linkages can be approximately 0.03 inches thick. The buckling resistance of linkages 700 and 702 can be increased by adjusting the thickness or width of linkages 700 and 702. Furthermore, lateral buckling resistance can be improved by using tightly fitting pin joints. The proximal linkage 700 can be in a tensioned state and can be configured to distribute the load and provide lateral stability. If desired, the length of the proximal linkage 700 can be slightly shorter than the length of the distal linkage 702, causing the jaws of the end effector 102 to open outward to compensate for gaps or any deflection of jaws 108 and 110.

[0087] The linkages 700 and 702 can be made of materials such as 17-4 stainless steel to provide a safety factor to dissipate the load on the opening clamp 118. In some variations, the end effector 102 can be manufactured using metal injection molding or metal 3D printing.

[0088] The end effector 102 may include two separate pivots, one for pitch and one for yaw, positioned approximately 0.375 inches apart. When the clamp is closed, the distance from the first pivot to the proximal side of the clamp may be approximately 1.5 inches. The end effector 102 can articulate in both directions at 40 degrees of pitch and yaw from its center.

[0089] For the conventional left sixth intercostal approach, the end effector typically requires minimal articulation from the centerline. However, variations in anatomy, right bilateral access, and other future applications may necessitate some articulation. Given the small diameter of the elongated shaft 106, allowing it to be slightly bent may be advantageous.

[0090] Many embodiments have been described. However, those skilled in the art will understand that various changes and modifications can be made to this disclosure without departing from the spirit and scope of the embodiments. Elements of the systems, devices, apparatuses, and methods shown with any embodiment are exemplary for particular embodiments and can be used in combination or otherwise in other embodiments within this disclosure. For example, the steps of any method depicted in the drawings or described in this disclosure do not require a specific order or sequential sequence to achieve the desired result. Furthermore, other steps or operations may be provided, or steps or operations may be eliminated or omitted from the described methods or processes to achieve the desired result. Additionally, any component or portion of any apparatus or system described in this disclosure or depicted in the drawings may be removed, eliminated, or omitted to achieve the desired result. Furthermore, for the sake of brevity and clarity, certain components or portions of the systems, devices, or apparatuses shown or described herein have been omitted.

[0091] Therefore, other embodiments are within the scope of the appended claims, and the description and / or drawings may be considered illustrative rather than restrictive.

[0092] Each individual variant or embodiment described and illustrated herein has separate components and features that can be readily separated from or combined with features of any other variant or embodiment. Modifications can be made to adapt particular circumstances, materials, composition of substances, processes, process actions, or steps to the purpose, spirit, or scope of the invention.

[0093] The methods listed herein can be performed in any logically possible order of the listed events, and in the order in which the events are listed. Furthermore, additional steps or operations can be provided, or steps or operations can be eliminated to achieve the desired result.

[0094] Furthermore, when a range of values ​​is provided, every intermediate value between the upper and lower limits of that range, as well as any other specified value or intermediate value within that range, is included within the scope of this invention. Additionally, any optional features of the described inventive variations may be described and claimed independently or in combination with any one or more features described herein. For example, a description of a range from 1 to 5 should be considered as having 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., and individual digits within that range, such as 1.5, 2.5, etc., and any wholly or partially increments therein.

[0095] All existing subjects mentioned herein (e.g., publications, patents, and patent applications) are incorporated herein by reference in their entirety, except where such subject matter might conflict with the subject matter of this invention (in which case the content presented herein shall take precedence). The items mentioned are provided only for the reasons that they were disclosed prior to the filing date of this application. Nothing herein should be construed as an admission that this invention has no right to precede such material due to prior invention.

[0096] References to a single item include the possibility that multiple identical items exist. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said,” and “the” include plural indicators unless the context clearly indicates otherwise. It should also be noted that claims may be drafted to exclude any optional elements. Therefore, this statement is intended to serve as a preliminary basis for the use of such exclusive terms such as “merely,” “only,” and similar terms relating to the enumeration of elements of the claims, or the use of the restrictive term “negation.” Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0097] When such a phrase modifies multiple items or components (or an enumerated list of items or components), mentioning the phrase "at least one" means any combination of one or more of those items or components. For example, the phrase "at least one of 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.

[0098] In understanding the scope of this disclosure, the term "comprising" and its derivatives as used herein are intended to be open-ended terms that specify the presence of said 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 with similar meanings, such as the terms "including," "having," and their derivatives. Furthermore, when used in the singular, the terms "part," "section," "portion," "component," "element," or "part" may have a dual meaning of a single part or multiple parts. As used herein, the following directional terms "forward, backward, above, downward, vertical, horizontal, below, lateral, sideways, and vertical," and any other similar directional terms, refer to those positions of the equipment or apparatus or those directions in which the equipment or apparatus is translated or moved.

[0099] Finally, as used herein, degree terms such as “basically,” “about,” and “approximately” refer to a specified value or a value with a reasonable amount of deviation from the specified value (e.g., a deviation of at most ±0.1%, ±1%, ±5%, or ±10%, if these variations are appropriate) such that the final result is not significantly or substantially altered. For example, when degree terms such as “about” or “approximately” are used to refer to a number or value as part of a range, “about 1.0 cm” can be interpreted as meaning “1.0 cm” or “between 0.9 cm and 1.1 cm,” and the term can be used to modify both the minimum and maximum number or value.

[0100] Those skilled in the art will understand that the various methods disclosed herein can be embodied in non-transitory readable media, machine-readable media, and / or machine-accessible media containing readable and / or executable instructions compatible with a processor or server processor of a machine, device, or computing device. The structures and modules in the figures may be shown as distinct and communicate only with a few specific structures and not others. Structures may be combined with each other, may perform overlapping functions, and may communicate with other structures that will be connected but are not shown in the figures. Therefore, the specification and / or figures should be viewed in an illustrative rather than restrictive sense.

[0101] This disclosure is not intended to be limited to the specific forms set forth herein, but is intended to cover alternative forms, modifications, and equivalents of the variations or embodiments described herein. Furthermore, the scope of this disclosure fully encompasses other variations or embodiments that may become apparent to those skilled in the art based on this disclosure.

Claims

1. A medical device for applying an occlusion clamp, the medical device comprising: handle; An elongated shaft extending from the handle, the elongated shaft including a proximal end, a distal end, and a central lumen; An end effector located at the distal end of the elongated shaft, the end effector including a first jaw and a second jaw configured to engage the occlusion clamp and deliver the occlusion clamp to the target tissue, wherein the end effector includes a linkage mechanism configured to move the first jaw and the second jaw relative to each other; and multiple cables extending through the central lumen. A joint plate is connected to the handle, wherein the joint plate includes a central opening and a plurality of peripheral openings, wherein each of the plurality of peripheral openings receives a screw, wherein each screw receives one of the plurality of cables for tensioning the linkage mechanism. A joint connecting the articulated plate and the elongated shaft, the joint being configured to allow rotational movement between the handle and the elongated shaft.

2. The medical device according to claim 1, wherein, The joint is a ball-and-socket joint.

3. The medical device of claim 2 further includes an O-ring configured to engage with the ball joint and the articulated plate to lock the ball joint, thereby preventing joint movement of the end effector.

4. The medical device according to claim 1, wherein, The plurality of peripheral openings include a D-shaped cross-section.

5. The medical device according to claim 1, wherein, Each screw includes a through hole therethrough, wherein the through hole has a first through hole diameter and a second through hole diameter, wherein the first through hole diameter is smaller than the second through hole diameter.

6. The medical device of claim 5, further comprising a first ball and a second ball connected to each of the plurality of cables, wherein the first ball has a diameter smaller than the diameter of the first through-hole, wherein the second ball has a diameter larger than the diameter of the first through-hole, wherein pulling the cable distally pulls the first ball through the through-hole and engages the second ball to tension the cable.

7. The medical device according to claim 6, wherein, The first ball is connected to a ball socket joint within the end effector.

8. The medical device according to claim 1, wherein, The cable is crimped by the screw, thereby restricting axial movement of the cable.

9. The medical device according to claim 1, wherein, The end effector also includes a ball joint.

10. The medical device according to claim 9, wherein, The ball joint includes multiple openings, and the multiple cables are all connected to the multiple openings.

11. The medical device according to claim 9, wherein, The ball joint includes a slot in the ball, and the socket of the ball joint includes a pin, wherein the slot and the pin are connected to prevent circumferential rotation of the ball joint.

12. The medical device according to claim 1, wherein, The linkage mechanism includes a plurality of linkage rods connected to the first jaw and the second jaw, wherein the plurality of linkage rods transmit force from the plurality of cables to the first jaw and the second jaw.

13. The medical device according to claim 1, wherein, Each of the multiple cables comprises multiple wires.

14. A system for use in a patient with occluded left atrial appendage, the system comprising: handle; An elongated shaft extending from the handle, the elongated shaft including a proximal end, a distal end, and a central lumen extending along the longitudinal axis of the elongated shaft; An end effector located at the distal end of the elongated shaft, the end effector including a first jaw and a second jaw configured to engage a occlusion clamp and deliver the occlusion clamp to target tissue, wherein the end effector includes a linkage mechanism configured to move the first jaw and the second jaw relative to each other. Multiple cables extend through the central cavity; A joint plate, which is connected to the handle; A joint connecting the joint plate and the shaft, the joint being configured to allow rotational movement between the handle and the elongated shaft; and wherein the handle includes a lever portion configured to rotate in a first plane perpendicular to the longitudinal axis, wherein the lever portion is configured to rotate in a second plane perpendicular to the first plane, wherein rotation of the lever portion in the first plane causes the end effector to move in a yaw direction, and rotation of the lever portion in the second plane causes the end effector to move in a pitch direction.

15. The system according to claim 14, wherein, The handle also includes a grip portion configured to be gripped by an operator with one or more fingers, wherein the articulated plate is located between the grip portion and the lever portion.

16. The system according to claim 14, wherein, The lever portion rotates 45 degrees in a first direction and 45 degrees in a second direction in the first plane, wherein the lever portion rotates 45 degrees in the first direction and 45 degrees in the second direction in the second plane.

17. The system according to claim 14, wherein, The handle includes a thumb portion extending from the lever portion, wherein the thumb portion extends at a 45-degree angle to the longitudinal axis of the elongated shaft.

18. A medical device for applying an occlusion clamp, the medical device comprising: handle; An elongated shaft extending from the handle, the elongated shaft including a proximal end, a distal end, and a central lumen; An end effector located at the distal end of the elongated shaft, the end effector including a first jaw and a second jaw configured to engage the occlusion clamp and deliver the occlusion clamp to the target tissue; and multiple cables extending through the central lumen. A joint plate, the joint plate being connected to the handle, wherein the joint plate includes a central opening and a plurality of peripheral openings, wherein each of the plurality of peripheral openings receives a screw. A joint connecting the articulated plate and the elongated shaft, the joint being configured to allow rotational movement between the handle and the elongated shaft; A joint locking system, located within the handle, wherein the joint locking system includes a ring configured to engage the joint joint and the joint plate, such that the joint joint and the joint plate are locked, thereby locking the end effector.

19. The medical device according to claim 18, wherein, The articulated locking system also includes a brake actuator plate, wherein the brake actuator plate is configured to release the ring from engagement with the articulated joint and the articulated plate when the occluder clamp is released.

20. The medical device of claim 19, further comprising an elastic member coupled to the brake actuator plate.

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