Re-capturable left atrial appendage gripping device and method for re-capturing left atrial appendage clip

Abstract

A recapturable external LAA disconnect clip system includes a clip including a first clip bar and a second clip bar, at least one of the clip bars having a connector interface including a first portion of a lock; and a delivery device comprising a handle and an end effector. The handle includes a jaw controller and a lock controller. The end effector is connected to the handle and includes a clevis and first and second jaws. The jaws are connected to the clevis and operably connected to a jaw controller to actively articulate at least one of the jaws relative to the other. At least one of the jaws has a connector including a second portion of the lock operably connected to the lock controller to removably lock with the first portion of the lock. The first and second portions of the lock have a locked state and are configured to unlock the locked state upon actuation of the lock controller.

Description

[0001] This invention patent application is a divisional application of the invention patent application with international application number PCT / US2020 / 031228, international application date May 3, 2020, application number 202080046180.0 entering the Chinese national phase, and name “Recapturing left atrial appendage clamping device and method for recapturing left atrial appendage clamp”. Technical Field

[0002] The present systems, devices and methods are generally in the field of surgical methods to externally occlude fluid passages in hollow tissue structures. Specifically, the present disclosure relates to devices, systems and methods for externally clamping the left atrial appendage ("LAA") of the heart to separate the LAA from the left atrium of the heart to effectively occlude the fluid passage between the LAA and the left atrium and recapture the clip after implantation. Background Art

[0003] Currently, the most common type of arrhythmia in the United States is atrial fibrillation (AF), which is characterized by chaotic and rapid electrical activity in the upper chambers of the heart. There are many causes and risk factors for the occurrence of atrial fibrillation, including hypertension, acute and chronic rheumatic heart disease, and hyperthyroidism. Due to this abnormal heart rhythm, the contraction of the atrial fibers is asynchronous (uncoordinated or inconsistent), so that the atria may stop pumping blood completely. Therefore, one of the most dangerous situations that occur during atrial fibrillation is the interruption or cessation of blood flow in the atria, which may lead to the formation of thrombi (blood clots), putting patients at high risk for heart attack or embolic stroke. Due to the anatomical location and physiological characteristics of the LAA, most blood clots caused by atrial fibrillation come from the LAA. The LAA is a pedicled and finger-like pocket-like cavity connected to the lateral wall of the left atrium between the mitral valve and the root of the left pulmonary vein. Therefore, when the heart does not contract at a normal and coordinated rate to push blood into the ventricles, the LAA is the main location for the harmful collection and accumulation of congested blood. Thus, a blood clot may easily form and accumulate in the LAA, grow on itself, and spread out of the LAA and into the atria. Therefore, because the LAA is prone to thrombosis, inhibiting or eliminating blood clots from forming in the LAA in patients with atrial fibrillation will greatly reduce the incidence of stroke in those patients.

[0004] Drug therapies such as blood thinners, anticoagulants and antiplatelet drugs are known and commonly used to reduce the risk of blood clot formation. However, these drugs are often associated with harmful and distressing side effects and complications, including excessive bleeding, headaches, dizziness, fatigue and contraindications, making patient compliance and tolerability very difficult. Therefore, there is great interest in developing alternatives that improve efficacy, limit any dangerous and chronic side effects and improve the quality of life of patients.

[0005] Therefore, another method to reduce or completely eliminate blood clot formation in the LAA is to effectively close or substantially restrict blood flow between the LAA and the left atrium through transthoracic, thoracotomy, thoracoscopy or percutaneous surgical intervention. The exact role of the LAA as part of the cardiovascular system is not fully understood. It is believed that the LAA may be suitable for use as a decompression chamber during left ventricular systole and other periods when left atrial pressure is high. However, the LAA does not seem to perform an essential function and is physiologically considered to be insignificant to the anatomy and function of the heart. Therefore, surgically resecting the fluid communication with the LAA or completely clearing (i.e., removing) the LAA from the heart is a promising and feasible method to completely reduce the risk of blood clot formation in the LAA.

[0006] Each of the existing surgical methods has its associated benefits and disadvantages. For example, complete removal of the LAA eliminates all risk of future blood clot formation therein. However, there is still a risk of displacing and releasing pre-existing blood clots into the bloodstream during the procedure. In addition, removal of the LAA creates a large incision in the heart that must be carefully controlled, expertly clamped, and sutured with absolute precision to avoid significant bleeding. Additionally, removal of the LAA is clearly a major anatomical change and should be considered carefully, as the hemodynamic and hormonal effects of the LAA remain a subject of ongoing research and understanding.

[0007] Other surgical approaches aim to seal, block or occlude the fluid passage between the LAA and the left atrium without removing any anatomical structures. For example, a surgeon may surgically suture or staple the LAA (e.g., via direct intra-atrial suturing or external ligation) to effectively close the passage, rendering the LAA merely a blind bag separated from the left atrium. In another example, a biocompatible barrier device may be implanted at the entrance of the LAA from within the left atrium using a percutaneous delivery device such as a vascular catheter and anchored within the passage. An example of such a device is the WATCHMAN®, sold by Boston Scientific Corporation. TM Left atrial appendage occluder. Although some of these procedures can be performed using minimally invasive techniques (e.g., thoracotomy, thoracoscopy), there is still considerable risk because cardiac tissue is punctured or the interior of the heart is invaded. In addition, the effectiveness of these procedures depends on the accurate placement of staples, sutures, implants or other occluding devices, and therefore requires ultra-precision from the surgeon. In addition, any foreign device left in the chamber of the heart has the potential to become a site of thrombosis in the future because some biocompatible materials will eventually decompose and / or promote clot formation. Therefore, it is urgent to develop different surgical methods for occluding or isolating the LAA that do not require actual destruction of cardiac tissue.

[0008] An example of such a procedure is the permanent surgical application of a breakaway clip to the outer surface of the LAA. Specifically, a breakaway clip is placed around the base of the LAA, applying sufficient tightening or clamping pressure to effectively seal the internal fluid passage between the LAA and the atrium without ever penetrating the heart. As a result, the likelihood of uncontrolled bleeding or other trauma to the heart is greatly reduced. Likewise, because no elements of the breakaway clip are introduced into the cardiovascular system, the risk of inadvertently creating a site that promotes future blood clot formation is minimal. Still, there are several inherent limitations in existing breakaway clip designs and current systems, procedures, and delivery devices for applying breakaway clips.

[0009] Given the background factors, existing separation clips currently used to isolate the LAA are generally composed of a pair of elongated, opposed clamping members that are urged together by one or more spring members. Prior to applying the separation clip to the LAA, a delivery device is engaged with the separation clip and applies a force that resists the spring-biased closing force of the spring members so as to separate the clamping members from each other and form an interior space therebetween. During application, the LAA is positioned within the interior space of the separation clip to be received between the opposed clamping members. Once the surgeon determines that the separation clip is at a desired position relative to the LAA, the delivery device of the clip releases the reaction force applied to the spring members and then disengages from the separation clip. As a result, the clamping members return to their inward spring-biased state, tightly surrounding the LAA in a gripping manner and producing a clamping action against the outer surface of the LAA. An example of such a device is the separation clip sold by AtriCure. Left atrial appendage separation system.

[0010] Currently, breakaway clamps are designed to be either open or closed loop. Closed loop breakaway clamps are typically comprised of a pair of parallel, opposing clamping members connected at both ends by a spring member to form a loop. In contrast, open breakaway clamps include a pair of opposing clamping members connected to each other at only a single end by a spring or spring-biased hinge-like member that urges the clamping members to pivot toward each other to produce the necessary clamping action.

[0011] Accordingly, to ensure the effectiveness and safety of the split clip method to isolate the LAA, the split clip must be accurately positioned relative to the LAA and other parts of the heart with sufficient pressure to adequately and permanently block blood flow into and out of the LAA without severing or otherwise damaging the LAA or any other surrounding tissue. Therefore, the surgeon must be skilled in controlling the placement of the split clip and ensuring that the clip is adequately closed and secured in place, which is a significant achievement. Once the split clip is in place on the LAA, the inserted tissue may dry out or otherwise shrink and change, requiring a different and greater clamping force to keep the LAA properly sealed.

[0012] Another limitation of existing separation clip designs (particularly closed loop designs) is that the distance of the internal opening between the relative clamping members is limited by the spring bias force applied by the spring member, wherein the spring bias force depends on the degree to which the spring member can bend. Therefore, when the patient's LAA is relatively large, the surgeon may have difficulty applying the separation clip.

[0013] Open LAA separation clips are sometimes preferred over closed clips because they only require access to the LAA from the side and, therefore, can be positioned with a less invasive procedure when access to the heart is limited. However, one disadvantage of open clips is that it is often difficult for the surgeon to determine when the clip has been fully positioned across the entire width of the LAA. Because the clip is placed using a lateral approach, the distal end of the LAA is often not visible to the surgeon. This requires the surgeon to estimate the distal position of the clip and release the clip when the surgeon believes the clip has spanned the entire LAA. If the surgeon's estimate is inaccurate and the open clip is only partially positioned across the LAA when it is released into the clamping configuration, only partial separation of the LAA is achieved. Such an implementation may result in complications requiring further surgery to correct the partial separation.

[0014] Therefore, there is a need in the art for an applicator device for an open LAA distraction clip that provides a positive indication to the surgeon that the clip has been fully positioned across the LAA before it is released into a clamped implanted configuration.

[0015] In addition, as described above, the LAA must be properly oriented and maintained in a stable position so that the LAA enters the internal space of the separation clip during the application of the separation clip. Therefore, instruments (such as surgical graspers) separate from the clip delivery device are generally used to manipulate the LAA into place. In fact, in the occlusion, separation and occlusion procedures of the LAA, it is necessary to use a separate instrument specifically for orienting the LAA into the appropriate position. Therefore, in the separation clip procedure, the surgeon must operate the clip delivery device and the stabilization instrument (or directly stabilize the heart) at the same time, thereby occupying the surgeon's hands. This limits the surgeon's movement and freedom and may also cause fatigue. Importantly, if not carefully performed, in a simple operation of the LAA, only a slight mistake will tear or puncture the LAA, which may lead to an immediate risk of life-threatening massive bleeding. Therefore, there is a need in the art for a separation clip and delivery device system that simplifies and improves the accuracy of the interaction between the separation clip and the LAA, and minimizes or eliminates the need and / or involvement of a separate grasping or nipping device for the LAA.

[0016] Furthermore, there is a need in the art for a separation clip having a shape, material properties, tolerances, and surface area characteristics that can improve the face-to-face interaction between the clamp's clamping members and both the LAA and the left atrium once the clip is in place, and that can enhance the grip of the separation clip around the LAA without causing any damage to the tissue not only during the surgical procedure but also throughout the life of the implanted clip.

[0017] During implantation of a breakaway clip, it is possible that the surgeon implants the clip, believing that the clip is in a desired location, but after releasing the breakaway clip from the delivery device, the surgeon believes that the clip should be removed and re-implanted. There is a need in the art for a delivery device that is able to engage and recapture a breakaway clip after it has been implanted in the LAA and open the breakaway clip for re-implantation in a more desirable location.

[0018] Therefore, a need exists to overcome the problems of prior art systems, designs and processes as discussed above. Summary of the invention

[0019] The described systems, devices, and methods provide devices, systems, and methods for clamping the outer surface of the left atrial appendage to separate the interior of the LAA from the left atrial fluid, which overcome the above-mentioned shortcomings of known devices and methods of this general type. More specifically, the described systems, devices, and methods provide a delivery device for a LAA separation clip, which has structural features that function in a manner that allows the LAA separation clip to be recaptured and reimplanted or removed during surgical application of the separation clip. Such a delivery device beneficially minimizes or eliminates the need for a stable instrument independent of the delivery device for manipulating the LAA relative to the separation clip, thereby resulting in a one-handed and contact-free procedure.

[0020] The described systems, devices, and methods further provide a closed-loop breakaway clip that provides the surgeon with greater precision and control over the degree of clamping pressure applied and is free from the traditional limitations imposed by the use of spring members to connect the terminals of opposing clamping members of the clip.

[0021] In one embodiment, the delivery device comprises a shaft having a proximal end and a distal end, a handle accommodating one or more controls connected to the proximal end of the shaft, and an applicator head connected to the distal end of the shaft. The applicator head comprises two opposing jaws adapted to receive an open separation clip. The jaws are pivoted between a closed position and an open position by a pivot assembly located at or near the proximal end of the applicator head attached to the shaft. The pivoting action of the jaws is controlled by one or more controls on the handle. There is a retaining member, such as an internal connector, at the tip of each of the jaws.

[0022] The delivery device can be used with a breakaway clip having a variety of different designs, whether known in the art or as indicated herein. In an open breakaway clip embodiment, the breakaway clip is placed between two opposing jaws, with the open end of the clip facing distally in the direction of the tips of the jaws. Each of the parallel clamping members of the breakaway clip is releasably fastened to a respective jaw. In this manner, when a control on the handle of the device is actuated to separate the opposing jaws, the breakaway clip is forced open. When the control is actuated to allow the opposing jaws to close, a spring in the breakaway clip urges the jaws closed.

[0023] The breakaway clip can be releasably secured to the jaws in a variety of different ways. Various exemplary embodiments utilize a lock that is removably secured within the interior space of the breakaway clip's clamp bar. When the operator is satisfied that the breakaway clip is properly positioned, a release device (e.g., a pull line) is actuated and the breakaway clip can be removed from the applicator clevis or head, thereby releasing the breakaway clip from the delivery device.

[0024] In operation, the surgeon opens the jaws and the separation clip by actuating the appropriate control on the handle to begin applying the separation clip. In an open-end embodiment of a separation clip, the open end is then positioned to span the LAA through a lateral approach. When the surgeon believes that the clip has been fully inserted to completely span the LAA when closed, the handle control is actuated to allow the clip to close, thereby clamping the LAA. If the surgeon correctly estimates the insertion distance of the clip, the tips of the relative jaws will be very close to each other and there will be no structure (such as the LAA) between them. The surgeon can then reopen the clip and try to correctly position the clip until the ideal implantation position is reached. The surgeon then actuates the release device and releases the separation clip from the jaws of the delivery device. The delivery device is removed to complete the implantation. If the surgeon desires, the delivery device can reengage the separation clip.

[0025] In view of the foregoing and other purposes, a recaptureable external left atrial appendage (LAA) separation clip system is provided, which includes a LAA separation clip and a delivery device. The separation clip includes a first clamp rod and a second clamp rod, at least one of the first clamp rod and the second clamp rod having a connector interface including a first portion of a lock. The delivery device includes: a handle, the handle including a jaw controller and a lock controller; an end effector, the end effector is connected to the handle and includes a U-shaped clamp and a first jaw and a second jaw connected to the U-shaped clamp, and is operably connected to the jaw controller to actively articulate at least one of the first jaw and the second jaw relative to the other, at least one of the first jaw and the second jaw having a connector, the connector including a second portion of a lock that is operably connected to the lock controller to removably lock with the first portion of the lock. The first and second portions of the lock have a locked state and are configured to unlock the locked state when the lock controller is actuated.

[0026] In view of these purposes, there is also provided a recaptureable external LAA separation clip system, the system comprising a LAA separation clip and a delivery device. The LAA separation clip comprises a first clamp rod and a second clamp rod, at least one of the first clamp rod and the second clamp rod having an internal connector interface including a first portion of a lock. The delivery device comprises a handle, the handle comprising a jaw controller and a lock controller; an end effector, the end effector being connected to the handle and comprising a U-shaped clamp and a first jaw and a second jaw connected to the U-shaped clamp, and the end effector being operably connected to the jaw controller to actively articulate at least one of the first jaw and the second jaw relative to the other, at least one of the first jaw and the second jaw having a connector, the connector comprising a second portion of a lock operably connected to the lock controller to removably lock with the first portion of the lock. The first portion and the second portion of the lock have a locked state and are configured to unlock the locked state when the lock controller is actuated and automatically enter the locked state when the first portion and the second portion of the lock are moved together.

[0027] With these objectives in mind, a recaptureable external LAA separation clip system is also provided, the system comprising a LAA separation clip and a delivery device. The separation clip comprises: a first clamping rod having a first tissue contacting surface, a second clamping rod having a second tissue contacting surface opposite to the first tissue contacting surface, the first clamping rod and the second clamping rod being formed to be assembled on opposite sides of the LAA, each of the first clamping rod and the second clamping rod having an internal connector interface, and at least one of the first clamping rod and the second clamping rod comprising a first portion of a lock; and a biasing device that movably connects the first clamping rod and the second clamping rod together. The delivery device comprises a handle comprising a hollow shaft defining a lumen, a lock controller having a clamp lock rope passing through the lumen, and a jaw trigger having an end effector rope passing through the lumen. The end effector is attached to the shaft and includes a clevis and first and second inner connectors operably connected to the end effector cord to pivot the first and second inner connectors relative to the clevis, at least one of the first and second inner connectors having a second portion of the lock operably connected to the clip lock cord and shaped to removably lock with the first portion of the lock, and having different lengths and each pivotally connected to the clevis so that when the longer of the first and second inner connectors is at least partially inserted into one of the first and second inner connector interfaces, movement of the handle allows a user to passively align the shorter of the first and second inner connectors into the other of the first and second inner connector interfaces. The first and second portions of the lock have a locked state and are configured to unlock when locked together upon actuation of a lock controller; and automatically enter the locked state without actuation of the lock controller when the first and second portions of the lock are moved together.

[0028] According to another feature, the connector interface includes a first internal connector interface and a second internal connector interface; the first clamp rod includes a first proximal end defining the first internal connector interface, the second clamp rod includes a second proximal end defining the second internal connector interface, the connector includes a first internal connector formed to be connected within the first internal connector interface, and a second internal connector formed to be connected within the second internal connector interface; the first jaw includes the first internal connector, the second jaw includes the second internal connector, and one of the first internal connector and the second internal connector is longer than the other of the first internal connector and the second internal connector.

[0029] According to another feature, the first inner connector is shaped to connect within either of the first inner connector interface and the second inner connector interface and the second inner connector is shaped to connect within either of the first inner connector interface and the second inner connector interface.

[0030] According to additional features, at least one of the first clamping lever and the second clamping lever has a proximal end defining the connector interface as a bore including a lock aperture as a first portion of the lock.

[0031] According to additional features, the first clamp rod includes a first proximal end defining the first internal connector interface as a hole, wherein the first portion of the lock is connected to the hole, or the second clamp rod includes a second proximal end defining the second internal connector interface as a hole, wherein the first portion of the lock is connected to the hole.

[0032] According to yet another feature, the first clamp rod includes a first proximal end defining a first internal connector interface as a first hole, wherein a first portion of the lock is connected to the first hole; the second clamp rod includes a second proximal end defining a second internal connector interface as a second hole, wherein a first portion of the lock is connected to the second hole; the first jaw includes a connector as a first internal connector, which includes a second portion of the lock and is formed to be connected within the first internal connector interface; and the second jaw includes a connector as a second internal connector, which includes a second portion of the lock and is formed to be connected within the second internal connector interface.

[0033] According to yet another feature, the first internal connector and the second internal connector have different lengths and are each pivotally connected to the U-shaped clamp, so that when the longer one of the first internal connector and the second internal connector is at least partially inserted into one of the first internal connector interface and the second internal connector interface, movement of the handle allows a user to passively align the shorter one of the first internal connector and the second internal connector into the other of the first internal connector interface and the second internal connector interface.

[0034] According to another additional feature, the second portion of the lock of each of the first and second inner connectors is operably connected to a lock controller and is configured to unlock with the corresponding first portion of the lock when the lock controller is actuated.

[0035] According to yet another additional feature, the connector interface is an internal connector interface, the connector is an internal connector including a second portion of the lock; at least one of the first clamp rod and the second clamp rod includes a proximal end defining the internal connector interface as a hole, wherein the first portion of the lock is connected to the hole, and at least one of the first jaw and the second jaw includes an internal connector and is formed to be connected within the internal connector interface.

[0036] According to yet another feature, the first jaw and the second jaw are each pivotally connected to a U-shaped clamp; the first jaw is operably connected to a jaw controller to actively articulate relative to the U-shaped clamp, and the second jaw is operably connected to a jaw controller to actively articulate relative to the U-shaped clamp.

[0037] According to yet another feature, a first actuation direction of the jaw control causes the first jaw and the second jaw to separate from each other and a second actuation direction of the jaw control causes the first jaw and the second jaw to move toward each other.

[0038] According to yet another additional feature, the second portion of the lock is configured to removably lock with the first portion of the lock.

[0039] According to yet another additional feature, the first and second parts of the lock are configured to automatically enter the locked state as the first and second parts of the lock move together.

[0040] According to yet another feature, a shaft is provided connecting the end effector to the handle and the jaw controller includes a jaw control cable connected to at least one of the first jaw and the second jaw, and the lock controller includes at least one lock release cable connected to the second portion of the lock.

[0041] According to yet another feature, the first clamping rod has a first tissue contact surface; the second clamping rod has a second tissue contact surface opposite the first tissue contact surface; and actuation of the jaw controller causes the first tissue contact surface and the second tissue contact surface to selectively move toward or away from each other in the clamping rod plane.

[0042] According to yet another additional feature, at least one of the first clamp rod and the second clamp rod has a proximal end; the connector interface extends from the proximal end into at least one of the first clamp rod and the second clamp rod and includes a lock aperture as a first part of the lock; and the connector includes a cord lock as a second part of the lock, and the cord lock is configured to be removably secured to the lock aperture.

[0043] According to yet another additional feature, the entirety of the LAA separation clip defines a cross-sectional circle having a given outer diameter equal to or less than 10 mm; and the end effector defines a transverse cross-sectional circle having an outer diameter no greater than the given outer diameter.

[0044] According to another feature, at least one of the first clamping rods includes a first proximal end defining the internal connector interface as a hole, the hole including a first portion of a lock; and the second clamping rod includes a second proximal end defining the internal connector interface as a hole, the hole including a first portion of a lock, at least one of the following: the first jaw includes a connector as an internal connector, the connector includes a second portion of the lock and is formed to be connected within the internal connector interface; and the second jaw includes a connector as an internal connector, the internal connector includes a second portion of the lock and is formed to be connected within the internal connector interface.

[0045] According to yet another feature, the first clamp rod includes a first proximal end defining a first internal connector interface as a hole, wherein the hole includes a first portion of a lock; the second clamp rod includes a second proximal end defining a second internal connector interface as a hole, wherein the hole includes a first portion of a lock; the first jaw includes a connector as a first internal connector, the connector includes a second portion of the lock and is formed to be connected within the first internal connector interface; and the second jaw includes a connector as a second internal connector, the connector includes a second portion of the lock and is formed to be connected within the second internal connector interface; and the first internal connector and the second internal connector have different lengths and are each pivotally connected to the U-shaped clamp, so that when the longer one of the first internal connector and the second internal connector is at least partially inserted into one of the first internal connector interface and the second internal connector interface, movement of the handle allows the user to passively align the shorter one of the first internal connector and the second internal connector into the other of the first internal connector interface and the second internal connector interface.

[0046] According to an accompanying feature, each of the first and second internal connector interfaces includes a first portion of a lock; and each of the first and second internal connectors includes a second portion of the lock to which the respective first portion of the lock is removably secured.

[0047] Although the systems, devices and methods are shown and described herein as embodying devices, systems and methods for clamping the LAA from the outside to separate the LAA from the left atrium of the heart to effectively block the fluid passage between the LAA and the left atrium and recapture the clip after implantation, it is not intended to be limited to the details shown, as various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope of equivalents of the claims. In addition, known elements of the exemplary embodiments will not be described in detail or will be omitted to avoid obscuring the relevant details of the systems, devices and methods.

[0048] Additional advantages and other features of the systems, devices and methods will be described in detail below and may be apparent from the detailed description or may be learned through practice of the exemplary embodiments. Still other advantages of the systems, devices and methods may be achieved by the tools, methods or combinations specifically pointed out in the claims.

[0049] Other features that are considered to be characteristic of the systems, devices, and methods are set forth in the appended claims. Detailed embodiments of the systems, devices, and methods are disclosed herein as needed; however, it should be understood that the disclosed embodiments are merely examples of systems, devices, and methods that can be implemented in various forms. Therefore, the specific structural and functional details disclosed herein are not to be construed as limiting, but are merely used as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art to employ the systems, devices, and methods in different ways with almost any suitable detailed structure. Further, the terms and phrases used herein are not intended to be limiting; rather, they are used to provide an understandable description of the systems, devices, and methods. Although the specification ends with claims defining the systems, devices, and methods of the present invention that are considered to be novel, it is believed that the systems, devices, and methods will be better understood by considering the following description in conjunction with the accompanying drawings, in which similar figure numbers are carried. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The accompanying drawings, in which like reference numerals represent the same or functionally similar elements in the various views, are not necessarily drawn to scale and, together with the detailed description below, are incorporated into and constitute a part of this specification for illustrating further various embodiments and explaining all the various principles and advantages of the systems, devices and methods. The advantages of the embodiments of the systems, devices and methods will become apparent from the following detailed description of exemplary embodiments of the systems, devices and methods, which description should be considered in conjunction with the accompanying drawings, in which:

[0051] Figure 1 is a partial illustration of a human heart with a left atrial appendage;

[0052] Figure 2 is a partial cross-sectional view of an exemplary embodiment of a blocking or separating clip showing only the clamping rod of the clip;

[0053] Figure 3 is a side elevation view of an exemplary embodiment of a clip delivery device having an end effector with a U-clip and jaws in a jaw closed state, a shaft and a handle, and an occluding clip mounted on the jaws;

[0054] Figure 4 yes Figure 2 A partial cross-sectional view of an end effector and a blocking clip, wherein the blocking clip is a certain distance away from the jaws;

[0055] Figure 5 yes Figure 4 A partial cross-sectional view of an end effector and an occluding clip, wherein the occluding clip is partially mounted on the jaws in a first intermediate state;

[0056] Figure 6 yes Figure 4 A partial cross-sectional view of an end effector and an occluding clip, wherein the occluding clip is further partially mounted on the jaws in a second intermediate state;

[0057] Figure 7 yes Figure 4 A partial cross-sectional view of an end effector and an occluding clip, wherein the occluding clip is removably mounted on the jaws;

[0058] Figure 8 yes Figure 7 A partial enlarged cross-sectional view of the end effector and the middle part of the occluding clip;

[0059] Fig. 8A yes Figure 7 An enlarged partial cross-sectional view of an end effector and a middle portion of an occluding clip of an alternative exemplary embodiment using an internal connector of the end effector, an internal connector interface of a clamp rod, and a locking feature of a lock to removably secure the occluding clip to the end effector;

[0060] Fig. 9 yes Figure 7 A partial cross-sectional view of an end effector and an occluding clip, wherein the jaws are in an open state and the clamping rods of the occluding clip are open with the tips facing away from each other;

[0061] Fig.10 yes Figure 7 A partial cross-sectional view of an end effector and an occluding clip, wherein the jaws are in an open state and the clamping bars of the occluding clip are open with the tips pointing toward each other;

[0062] Fig.11 yes Figure 7 A partial perspective view of an end effector and an occluding clip;

[0063] Fig.12 is a partial perspective view of an exemplary embodiment of an occluding clip having a U-shaped clamp and jaws in a closed jaw state, and an end effector with the jaws at a distance from the jaws and only the clamping rod of the clamp shown;

[0064] Fig.13 yes Fig.12 A partial perspective view of an end effector and an occluding clip of , wherein the occluding clip is partially mounted to the jaws in a first intermediate state;

[0065] Fig.14 yes Fig.12 A partial perspective view of the end effector and the occluding clip, wherein the occluding clip is further partially mounted to the jaws in a second intermediate state;

[0066] Fig.15 yes Fig.12 A partial perspective view of an end effector and an occluding clip, wherein the occluding clip is removably mounted on the jaws;

[0067] Fig.16 yes Fig.15 A partially perspective and partially transparent view of an end effector and an occluding clip;

[0068] Fig.17 yes Fig.16 The end effector and occluding clip are rotated to view a partially enlarged perspective and partially transparent view of the underside;

[0069] Fig.18 is a partial cross-sectional view of an exemplary embodiment of an occluding clip having a U-shaped clamp and jaws in a closed jaw state, and the jaws are spaced apart from each other and only the clamping rod of the clamp is shown;

[0070] Fig.19 yes Fig.18 A partial cross-sectional view of an end effector and an occluding clip, wherein the occluding clip is partially mounted on the jaws in an intermediate state;

[0071] Fig. 20 yes Fig.18 A partial cross-sectional view of an end effector and an occluding clip, wherein the occluding clip is removably mounted on the jaws;

[0072] Fig.21 yes Fig. 20 A partial perspective view of an end effector and an occluding clip;

[0073] Fig. 22 yes Figure 3 A partial perspective view of the end effector;

[0074] Fig.23 yes Figure 2 , Fig.12 , Fig.18 , Fig.34 , Fig.39 , Fig.41 , Fig.53 and Fig.66 A partial perspective view of an end effector and a clip, wherein the clip is mounted on the end effector in a closed state of the clip, adjacent to the LAA;

[0075] Fig.24 yes Fig. 22A partial perspective view of the end effector and the clip adjacent to the LAA in the clip open state;

[0076] Fig.25 yes Fig. 22 A partial perspective view of the end effector and the clip around the LAA in the open state of the clip;

[0077] Fig.26 yes Fig. 22 A partial perspective view of the end effector and the clip around the LAA in the clip closed state;

[0078] Fig. 27 yes Fig. 22 A partial perspective view of an end effector and a clip of FIG. 1 , wherein the clip is partially deployed in a state where the clip is installed around the LAA;

[0079] Fig.28 yes Fig. 22 A partial perspective view of an end effector and a clip of FIG. 1 , wherein the clip is deployed in a clip installation state around the LAA;

[0080] Fig.29 yes Figure 3 a partial, cut-away and partially transparent view of an end effector of a device of , with the jaws in a closed position;

[0081] Fig.30 yes Figure 3 a partial, cut-away and partially transparent view of an end effector of a device of , with the jaws in an open position;

[0082] Fig.31 yes Figure 3 a partial, cut-away and partially transparent view of an end effector of a device of , with the jaws in a closed position;

[0083] Fig.32 yes Figure 3 a partial, cut-away and partially transparent view of an end effector of a device of , with the jaws in an intermediate open state;

[0084] Fig.33 yes Figure 3 a partial, cut-away and partially transparent view of an end effector of a device of , with the jaws in an open position;

[0085] Fig.34 It is implanted in the representative LAA Figure 3 The clip and the adjacent clip Figure 3 A partial perspective view of a device wherein the first internal connector is outside of a first clamping bar of the clamp and the second internal connector is slightly inside of a second clamping bar of the clamp;

[0086] Fig.35 yes Fig.34 A partial perspective view of a clip and device of , wherein the second internal connector is slightly within the second clamping bar of the clip, and the clevis is rotated to move the first internal connector toward the entrance of the first clamping bar of the clip;

[0087] Fig.36 It is implanted in the LAA Figure 3 The clamp and Figure 3 A partial perspective view of a device of , wherein the first internal connector is slightly within the first clamping bar of the clamp and the second internal connector is slightly within the second clamping bar of the clamp;

[0088] Fig.37 It is implanted in the LAA Figure 3 The clamp and Figure 3 A partial perspective view of a device having a first internal connector and a second internal connector partially within a clamping bar of a corresponding clamp;

[0089] Fig.38 It is implanted in the LAA Figure 3 The clamp and Figure 3 A partial perspective view of a device having a first internal connector and a second internal connector locked within a clamping bar of a corresponding clamp;

[0090] Fig.39 yes Figure 3 A partial perspective view of an end effector and a portion of a clamp, wherein the clamp is in a partially open state;

[0091] Fig.40 yes Figure 3 A partial perspective view of an end effector and a portion of a clamp, wherein the clamp is in an open state;

[0092] Fig.41 is a perspective view from above of another exemplary embodiment of a left atrial appendage surgical implant clip in a closed or stable state orientation;

[0093] Fig.42 yes Fig.41 A perspective view of a longitudinal vertical section of a first clamping rod of a clamp, passing through the upper biasing means and the lower biasing means and through the first clamping rod, showing an interior hollow portion of the first clamping rod for receiving a portion of a clamp delivery device;

[0094] Fig.43 yes Fig.41 A perspective view of a longitudinal vertical section of a second clamping rod of a clamp, passing through the upper biasing means and the lower biasing means and through the second clamping rod, showing an interior hollow portion of the second clamping rod for receiving a portion of a clamp delivery device;

[0095] Fig.44 yes Fig.41 Bottom view of the middle clip;

[0096] Fig.45 yes Fig.41 Top view of the middle clip;

[0097] Fig.46 yes Fig.41 An elevation view of the distal end of the clamp;

[0098] Fig.47 yes Fig.41 An elevation view of the proximal end of the clamp;

[0099] Fig.48 yes Fig.41 A side elevation view of the outer side of the clamp;

[0100] Fig.49 yes Fig.41 A perspective view of the proximal end of the clamp viewed from below;

[0101] Fig.50 yes Fig.41 A partial perspective view of the outside of the middle portion of the first clamping bar and the second clamping bar of the clamp viewed from below, wherein the upper biasing device and the lower biasing device are removed as viewed from below the outside of the first clamping bar;

[0102] Fig.51 yes Fig.41 A partial perspective view of the proximal end of the intermediate portion of the first clamping bar and the second clamping bar of the clamp viewed from above, wherein the upper biasing device is removed and viewed from above the outer side of the second clamping bar;

[0103] Fig.52 yes Fig.41 A partial perspective view of the proximal end of the intermediate portion of the first clamping bar and the second clamping bar of the clamp viewed from above, wherein the upper biasing device and the lower biasing device are removed from the outside of the second clamping bar;

[0104] Fig.53 is a perspective view of an exemplary embodiment of another left atrial appendage surgical implant clip in a closed or stable state orientation, wherein a cross section of the upper biasing means and the lower biasing means passes through a centerline of the upper biasing means and the lower biasing means, showing a side adjacent to a second clamping bar, and the upper biasing means and the lower biasing means are schematically biased outwardly away from the second clamping bar;

[0105] Fig.54 yes Fig.53 an elevational view of a distal end of the clamp with a cross section of the upper biasing means and the lower biasing means passing through a centerline of the upper biasing means and the lower biasing means showing a side adjacent to the first clamping bar and the upper biasing means and the lower biasing means schematically biased outwardly away from the first clamping bar;

[0106] Fig.55 yes Fig.53 an elevational view of a proximal end of the clamp with a cross section of the upper biasing means and the lower biasing means passing through a centerline of the upper biasing means and the lower biasing means showing a side adjacent to the second clamping rod and the upper biasing means and the lower biasing means schematically biased outwardly away from the second clamping rod;

[0107] Fig.56 yes Fig.53 a partial perspective view of a distal portion of the clamp with a cross section of the upper biasing means and the lower biasing means passing through a centerline of the upper biasing means and the lower biasing means showing a side adjacent to the first clamping bar and the upper biasing means and the lower biasing means schematically biased outwardly away from the first clamping bar;

[0108] Fig.57 It passes through Fig.53 A perspective view of a longitudinal vertical section of an upper biasing device and a lower biasing device of a clamp and a first clamping rod, showing an interior hollow portion of the first clamping rod for receiving a portion of a clamp delivery device, portions of the upper biasing device and the lower biasing device, and the first clamping rod shown in hollow section;

[0109] Fig.58 yes Fig.53 Bottom view of the middle clip;

[0110] Fig.59 yes Fig.53 Top view of the middle clip;

[0111] Fig.60 yes Fig.53 a perspective view from below of the outer side of a first clamping bar of a clamp with the upper biasing device removed and a cross section of the lower biasing device through its centerline showing a side adjacent to the second clamping bar and the lower biasing device schematically biased outwardly away from the second clamping bar;

[0112] Fig.61 yes Fig.53 A side elevation view of the outside of a first clamping bar of the clamp, wherein a cross section of the upper biasing means and the lower biasing means passes through a centerline of the upper biasing means and the lower biasing means, showing a side adjacent to the first clamping bar and the upper biasing means and the lower biasing means are schematically biased outwardly away from the first clamping bar;

[0113] Fig.62 yes Fig.53 A perspective view of a proximal end of the clamp viewed from above, with a cross section of the upper biasing means and the lower biasing means passing through a centerline of the upper biasing means and the lower biasing means showing a side adjacent to the second clamping bar and the upper biasing means and the lower biasing means schematically biased outwardly away from the second clamping bar;

[0114] Fig.63 yes Fig.53a perspective view of the distal outer side of the first clamping bar viewed from above, wherein a longitudinal horizontal section of the clamp shows the internal hollow portions of the first clamping bar and the second clamping bar for receiving portions of the corresponding clamp delivery device and a section of the lower biasing device passing through the centerline thereof, showing a side adjacent to the first clamping bar and the lower biasing device schematically biased outwardly away from the first clamping bar, the first clamping bar being partially hollow in section;

[0115] Fig.64 yes Fig.53 a perspective view from above of an outer side of a proximal end of a second clamping bar, wherein a cross section of the upper biasing means and the lower biasing means passes through a centerline of the upper biasing means and the lower biasing means, showing a side adjacent to the first clamping bar and the upper biasing means and the lower biasing means are schematically biased outwardly away from the first clamping bar; Fig.65 yes Fig.53 a perspective view of the outer side of the distal end of the second clamping bar viewed from above, with a longitudinal vertical and hollow section of the second clamping bar, wherein the section of the upper biasing means and the lower biasing means passes through the center line of the upper biasing means and the lower biasing means, showing the side adjacent to the first clamping bar and the upper biasing means and the lower biasing means schematically biased outwardly away from the first clamping bar;

[0116] Fig.66 yes Fig.53 A partial perspective view from above of an exemplary embodiment of a clip of the embodiment of the present invention and a distal end of a delivery device with an open and closed clip contact end removably attached to a proximal end of the clip in a fully closed orientation of the clip ready for implantation;

[0117] Fig.67 yes Fig.66 A perspective view of a clip and a delivery device in a first intermediate clip open orientation, wherein the proximal ends of the clips are separated from each other;

[0118] Fig.68 yes Fig.66 a perspective view of a clamp and a delivery device in a second intermediate clamp open orientation, wherein the proximal and distal ends of the clamp are separated from each other to position the first clamp bar and the second clamp bar substantially parallel to each other;

[0119] Fig.69 yes Fig.66 a perspective view of a clamp and a delivery device in a fully opened orientation of the clamp, wherein the proximal and distal ends of the clamp are separated from each other to position the distal ends of the first clamp bar and the second clamp bar further away from each other than the proximal ends of the first clamp bar and the second clamp bar;

[0120] Fig.70 yes Fig.53 An elevational view of the proximal end of the clamp, wherein a longitudinal vertical section of the upper biasing means and the lower biasing means passes through the centerline of the upper biasing means and the lower biasing means, showing a side adjacent to the first clamping rod;

[0121] Fig.71 yes Figure 2 , Fig.12 , Fig.18 , Fig.34 , Fig.39 , Fig.41 , Fig.53 and Fig.66 Schematic plan views of exemplary embodiments of alternative configurations of upper and lower biasing means of a clip;

[0122] Fig.72 is a schematic cross-sectional view of an exemplary embodiment of a locking configuration between a delivery device and a LAA separation clip, wherein the delivery device is in a locked state of the clip;

[0123] Fig.73 yes Fig.72 A schematic cross-sectional view of a configuration of wherein the delivery device is in an unlocked state of the clip before the clip is removed from the delivery device;

[0124] Fig.74 yes Fig.72 A schematic cross-sectional view of a configuration of wherein the delivery device is in an unlocked state of the clip after the clip is removed from the delivery device;

[0125] Fig.75 is a perspective view of an exemplary embodiment of a biasing device for separating clips;

[0126] Fig.75A yes Fig.75 A perspective view of the biasing device before bending;

[0127] Fig.76 is a perspective view of another exemplary embodiment of a biasing device for separating clips;

[0128] Fig.76A yes Fig.76 A perspective view of the biasing device before bending;

[0129] Fig.77 is a side elevation view of another exemplary embodiment of a clip delivery device having: a jaw end effector with a U-clip and in a jaw closed state, a shaft and a handle with a jaw trigger, an unlock button, and a shaft rotation wheel;

[0130] Fig.78 yes Fig.77 A side elevation view of a clip delivery device of , wherein the occluding clip is mounted on the jaws of the end effector;

[0131] Fig.79 yes Fig.77An enlarged side elevation view of a portion of a distal end portion of a shaft and an end effector of a clip delivery device; and

[0132] Fig.80 Is the axis Fig.77 A partial enlarged side elevation view of the distal portion and end effector of a clip delivery device with the half facing the U-clip removed to show the jaws and lock controller of the end effector. DETAILED DESCRIPTION

[0133] As required, detailed embodiments of the systems, devices, and methods are disclosed herein; however, it should be understood that the disclosed embodiments are merely examples of systems, devices, and methods that can be implemented in various forms. Therefore, the specific structural and functional details disclosed herein are not to be construed as limiting, but are merely used as the basis for the claims and as a representative basis for teaching those of ordinary skill in the art to employ the systems, devices, and methods in different ways with almost any suitable detailed structure. Further, the terms and phrases used herein are not intended to be limiting; rather, they are used to provide an understandable description of the systems, devices, and methods. Although the specification ends with claims defining the features of the systems, devices, and methods of the present invention that are believed to be novel, it is believed that the systems, devices, and methods will be better understood by considering the following description in conjunction with the accompanying drawings, in which similar figure numbers are carried.

[0134] In the following detailed description, reference is made to the accompanying drawings which form a part thereof, and in which embodiments that can be practiced are shown by way of illustration. It should be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope. Therefore, the following detailed description should not be made in a limiting sense, and the scope of the embodiments is defined by the appended claims and their equivalents.

[0135] Alternative embodiments may be devised without departing from the spirit or scope of the invention.In addition, known elements of exemplary embodiments of the systems, devices, and methods will not be described in detail or will be omitted to avoid obscuring the relevant details of the systems, devices, and methods.

[0136] Before disclosing and describing the system, equipment and method, it should be understood that the terms used herein are only used for the purpose of describing specific embodiments and are not intended to be restrictive. The term "comprises", "comprising" or any other variant thereof is intended to cover non-exclusive inclusions, so that the process, method, article or device containing a series of elements not only includes those elements, but may also include other elements that are not explicitly listed in such processes, methods, articles or equipment or are inherent to them. In the absence of more restrictions, the element starting with "comprising..." does not exclude the presence of other identical elements in the process, method, article or equipment containing the element. As used herein, the term "including" and / or "having" is defined as including (i.e., open language). As used herein, the term "one" or "a kind" is defined as one / kind or more than one / kind. As used herein, the term "multiple" is defined as two or more than two. As used herein, the term "another" is defined as at least the second or more. The term "one or more embodiments" may be used in the description, which refers to one or more identical or different embodiments.

[0137] The terms "coupled" and "connected," and their derivatives, may be used. It should be understood that these terms are not intended to be synonymous with each other. Instead, in certain embodiments, they may be used to indicate that two or more elements are in direct physical or electrical contact with each other. "Coupled" may refer to two or more elements being in direct physical or electrical contact (e.g., directly coupled). However, "coupled" may also refer to two or more elements not being in direct contact with each other, but still cooperating or interacting with each other (e.g., indirectly coupled).

[0138] For descriptive purposes, a phrase of the form "A / B" or of the form "A and / or B" or of the form "at least one of A and B" means (A), (B), or (A and B), where A and B are variables indicating specific objects or attributes. When used, the phrase is intended to and is defined herein as a selection of A or B, or both A and B, similar to the phrase "and / or". When there are more than two variables in such a phrase, the phrase is defined herein to include only one of the variables, any one of the variables, any combination of any variables, and all of these variables, e.g., a phrase of the form "at least one of A, B, and C" means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C).

[0139] Relational terms, such as first and second, top and bottom, etc., may be used only to distinguish one entity or action from another entity or action, without necessarily requiring or implying any substantial such relationship or order between such entities or actions. Descriptions may use perspective-based descriptions, such as up / down, back / front, top / bottom, and proximal / distal. Such descriptions are only used to facilitate discussion and are not intended to limit the application of the disclosed embodiments. Various operations may be described as multiple independent operations in sequence in a manner that is helpful for understanding the embodiments, however, the order of description should not be interpreted as implying that the operations are sequentially related.

[0140] As used herein, the term "about" or "approximately" applies to all numerical values, whether or not it is explicitly indicated. These terms generally refer to a numerical range that a person skilled in the art will consider to be equivalent to the value (i.e., having the same function or result). In many cases, these terms may include numbers rounded to the nearest significant figure. As used herein, the terms "substantially" and "substantially" refer to that when the various parts are compared to each other, the compared parts are equal in size or close enough so that a person skilled in the art would consider the same. As used herein, substantially is not limited to a single dimension, and specifically includes a series of values ​​of the compared parts. The range of values, including both above or below (e.g., "+ / -" or above / below or greater than / less than), includes changes that a person skilled in the art would know as reasonable tolerances for the parts.

[0141] Various embodiments of systems, devices, and methods are described herein. In a number of different embodiments, features are similar. Therefore, in order to avoid redundancy, these similar features are no longer described repeatedly in some cases. However, it should be understood that the description of the first occurrence of a feature is applicable to similar features described later, and therefore, each corresponding description is incorporated therein without repetition.

[0142] What is now described is an exemplary embodiment. Reference will now be made in detail to the drawings and in particular to the drawings. Figures 2 to 10 , which depicts a clip delivery device 1600 and a distal portion of a first exemplary embodiment of an externally implantable and spring-biased left atrial appendage separation clip 1500.

[0143] Figure 1 The front view of the center heart 10 shows how the LAA 20 extends from and abuts against the outer surface 14 of the left atrium 12 to form a flap. In most cases, this flap formed by the LAA 20 abutting against the outer surface 14 is loose, and the surgeon is able to manipulate the LAA 20 with a blunt Kittner dissector to stand up the LAA to allow the LAA to cross at the base 22. In this position, the inner portion of the separation clip 1500 (e.g., Fig. 91572) is placed over the outermost point of LAA 20 and the separation clip 1500 is slid down and around all sides of LAA 20 so that the surgeon separates the sides of the LAA of the clip 1500 (e.g., Fig. 9 1511, 1521) are positioned at the base of the LAA 20 against two opposing sides of the LAA 20. In some cases, however, the LAA 20 may have an adhesive force that will keep a portion of the side 24 of the LAA 20 that faces the left atrium 12 facing the left atrium 12 or the pericardium. In this case, the flaps of the LAA 20 are fixed in one or more areas and therefore cannot be manipulated by the surgeon to make the LAA 20 stand away from the outer surface 14 of the left atrium 12. More specifically, the right base of the LAA 20 ( Figure 1 The left side of the cervix is ​​open and accessible to the surgeon, but the opposite side - the left base ( Figure 1 In the presence of adhesion forces, the LAA 20 may still be sufficiently manipulated to allow the rod-like device to be inserted between the LAA 20 and the outer surface 14 of the left atrium 12 and to pass from under the LAA along the left side of the base 22 of the LAA 20 (from front to back) and through to the other side of the LAA 20 (adjacent to the pulmonary artery). This means that if the separation clip has a closed loop at the distal end of the clip, the surgeon will be required to physically separate the left side of the LAA from the surface of the heart to use this particular clip. This separation is problematic for a number of reasons, one of which is that it can cause the LAA to tear, which can have fatal consequences. Therefore, in this case, it is desirable to use a separation clip with an open distal end, such as clip 1500, to approach the LAA 20. The open separation clip allows the surgeon to insert one of the clip's rods between the left side of the LAA 20 and the left atrium 12 without peeling off the adhered portion of the LAA 20 from the outer surface 14 of the left atrium 12.

[0144] A desirable feature of a LAA separation clip (e.g., clip 1500) is the ability to easily recapture an implanted clip, either during the clip implantation procedure or after the clip has been implanted and present on the LAA 20 for a period of time. Recapture is desirable for a number of reasons. One reason for the need for recapture is after the LAA separation clip has been implanted in an undesirable manner. In this case, the final post-implantation imaging shows an undesirable placement of the clip, which may not be visible when the delivery device remains connected to the clip (in other words, when the clip is installed but not deployed from the delivery device). In order to implant the clip, the surgeon must manually manipulate the heart into a position that is favorable for deployment. In this case, the delivery device hinders the ability of the heart to return to its normal position, which therefore interferes with imaging of the clip in the final placement direction. The delivery device may also apply external forces that change the anatomical structure and make it impossible to actively confirm a good placement. If the surgeon cannot fully see the anatomical structure that the delivery device blocks such observation, the only way to view the actual placement is to release the clip from the delivery device. Since recapture is possible, reconnection allows repeated imaging and recapture until the desired implantation position is reached. When a clip cannot be recaptured after final placement, a second clip may be required to improve the surgical outcome if implantation was unsatisfactory, or the misplaced clip must be removed by manual measures, such as cutting the clip or grasping with a tool not intended for this purpose. In either case, the risk of patient injury is greatly increased. Implantation of more than one clip is undesirable and recapture minimizes the necessity for multiple clip implantations. If an implanted clip cannot be improved by implanting a second clip, it may be necessary to surgically resect the first clip from the LAA. This resection should be avoided because of the potential for atrium puncture with serious fatal consequences. In short, to optimally dissect the LAA, the surgeon should be able to repeatedly:

[0145] imaging of the implanted clips;

[0146] loosening of poorly implanted clips;

[0147] reposition the clip; and

[0148] Imaging of the repositioned implanted clip.

[0149] Desirably, the surgeon may repeat the release, repositioning, and implanting steps as desired until satisfactory placement occurs.

[0150] The exemplary embodiment of the clip 1500 is sized to fit into a thoracoscopic port having a lumen of a given diameter, such as 10 mm (30 French). The clip 1500 has clamping bars 1510, 1520. These clamping bars 1510, 1520 are biased with a biasing device (e.g., a spring) to force the LAA compression sides 1511, 1521 against each other, wherein the biasing device is Figure 2 and Figures 4 to 21 1500. For simplicity, other features of the clip 1500 are also not shown. The proximal ends of the clamp rods 1510, 1520 each have an internal connector interface 1512, 1522. These internal connector interfaces 1512, 1522 have inlets 1514, 1524 into which the corresponding internal connectors 1610, 1620 of the delivery device 1600 are inserted. At least one of the internal connector interfaces 1512, 1522 has a corresponding lock aperture 1516, 1526 into which the corresponding connector locks 1614, 1624 of the internal connectors 1610, 1620 are inserted. Both connector interfaces 1512, 1522 can have lock apertures 1516, 1526, as in the exemplary embodiment.

[0151] Delivery device 1600 is used to deliver clip 1500 to LAA 20. An exemplary embodiment of delivery device 1600 is shown in Figure 3 , in a pistol grip configuration. The delivery device 1600 has an end effector 1601, an axis 1609, and a handle portion 2000. The delivery device 1600 has a lock / unlock controller 2010 at the handle portion 2000 (e.g., actuated by a clamp lock pull cord). When actuated, the lock / unlock controller 2010 applies a force (e.g., on the clamp lock pull cord) to release the locks 1614, 1624 on the clamp rods 1510, 1520, thereby allowing the clip 1500 to leave the delivery device 1600 and be implanted. In order to recapture the clip 1500, the delivery device 1600 is moved to a recapture position and the first and second internal connectors 1610, 1620 (see, e.g., Figure 4 and Figure 5 ) are inserted into the first and second connector interfaces 1512, 1522 of the clamp bars 1510, 1520, respectively. In the exemplary embodiments described herein, the lock controller (e.g., the lock release rope 1610, 1620 and the lock / unlock controller 2010) can automatically lock during recapture or the lock can be manually operated to lock the connectors 1610, 1620 into the connector interfaces 1512, 1522.

[0152] A first exemplary embodiment of a selectable locking mechanism for clamping bars 1510, 1520 is Figures 4 to 11In order to minimize the outer diameter and allow for better port compatibility (e.g., to accommodate an inner diameter of approximately 10 mm / 30 Fr or less), it is desirable that the release of the clamping rods 1510, 1520 occurs "inside" the control end of the delivery device for the clamping rods 1510, 1520. An example of an internal release structure is a structure that releases the clamp 1500 from within the first and second internal connector interfaces 1512, 1522 in the form of blind holes.

[0153] Figures 4 to 21 The exemplary configuration shown demonstrates a variation of internal delivery device control of the clamping bars 1510 , 1520 (and thus the LAA clip) that allows for easy recapture and repositioning of the clip 1500 .

[0154] A first exemplary embodiment of an internal clamp lever control mechanism that allows recapture is shown in Figures 4 to 11 In. From Figures 4 to 7 The progress diagram shows the installation and implantation stages of the clip 1500 including the clamping rods 1510, 1520 (as mentioned above, for the sake of clarity, only the clamping rods 1510, 1520 of the clip 1500 are shown). Figure 4 Both the step of finally disconnecting the clamping bars 1510 , 1520 from the delivery device 1600 and the step of connecting the clamping bars 1510 , 1520 to the delivery device 1600 are shown.

[0155] In each of the embodiments, the delivery device 1600 includes first and second delivery cams 1602, 1604, which are respectively connected to the clamp bars 1510, 1520. The first and second delivery cams 1602, 1604 are pivotally connected to the first and second internal connectors 1610, 1620 at distal pivots 1603, 1605, respectively, and the first and second delivery cams 1602, 1604 are pivotally connected to the delivery U-clip 1608 at each of the first and second proximal pivots 1606, 1607, respectively. The cam-actuated connector, not shown, controls the movement of the delivery cams 1602, 1604 relative to each other (e.g., as shown in FIG. 1 ). Fig.10 and Fig.11). The use of first and second distal pivots 1603, 1605 creates beneficial properties. By allowing the first and second internal connectors 1610, 1620 to freely pivot about a small angle (e.g., between >0° and about 60°, in particular, between about 20° and about 40°, in particular, about 30°), the internal connectors 1610, 1620 are allowed to easily self-align, so that when the second internal connector 1620 is inserted (because it is longer) into the internal connector interface (e.g., 1512, 1522), the first internal connector 1610 can pivot as desired while the second internal connector 1620 remains relatively stationary, referred to herein as passive alignment. The lengths of the internal connectors 1610, 1620 are discussed in more detail below.

[0156] For example, in an exemplary alternative embodiment of the movement of the jaws pivoting about a pivot pin in a U-shaped clamp, the jaws and the U-shaped clamp are a single component with a living hinge for pivoting. In another exemplary embodiment, an arcuate track or limiter provides an actual pivot around which the jaws move. In addition, the end effector does not require pivoting motion to achieve the opening and closing movement of the clamp rods. The jaws can move symmetrically or asymmetrically around a central vertical plane between the clamp rods through non-rotational based motion, such as through a limiter feature such as a track or groove in the U-shaped clamp that guides the first jaw to move relative to the second jaw along a linear, curved or other non-linear path. In another exemplary embodiment, the jaws and the U-shaped clamp can be connected by a flexure so that the first jaw and the second jaw can move along a linear, curved or other non-linear path.

[0157] from Figures 4 to 7The progress of shows how the clamping rods 1510, 1520 are connected to the first and second internal connectors 1610, 1620, respectively. In this exemplary embodiment, the clamping rods 1510, 1520 have corresponding internal connector interfaces 1512, 1522, here in the form of cylindrical blind holes. Similarly, the first and second internal connectors 1610, 1620 have a first shaft rope and a second shaft 1612, 1622, wherein the outer shape of each shaft corresponds to the corresponding internal connector interface 1512, 1522 to fit therein. In this article, these shapes are similar, with a circular cross-section and a rounded tip. However, the shapes of the two shafts 1612, 1622 can be different, for example, one is a circular cross-section and the other is a polygonal cross-section. If the shafts 1612, 1622 are simply inserted into the internal connector interfaces 1512, 1522, then the clamping rods 1510, 1520 are likely to slip off. In order to hold each of the clamping rods 1510, 1520 on the corresponding shaft 1612, 1622, at least one of the inner connectors 1610, 1620 is provided with a connector lock 1614, 1624, or both of the inner connectors 1610, 1620 are provided with a connector lock 1614, 1624. Figures 4 to 10 In an exemplary embodiment of the present invention, the connector locks 1614, 1624 are in the form of a triangle. The triangle is formed by a deformable string (e.g., Nitinol or other nickel-titanium alloy wire) that acts as a "one-way" snap. The snap is considered to be one-way because it allows the internal connector 1610, 1620 to be easily inserted into the internal connector interface 1512, 1522 (the snap is bent for insertion), but prevents the internal connector 1610, 1620 from being removed from the internal connector interface 1512, 1522 until a given amount of force is overcome. More specifically, with respect to the Figures 4 to 7 To removably capture the clip onto the delivery device 1600, the shafts 1612, 1622 are slid into the internal connector interfaces 1512, 1522, respectively. Figure 5, the internal connectors 1610, 1620 are in a first intermediate insertion position. Here, the distal end of the clamp rod 1622 is within the second internal connector interface 1522, sufficiently to contact the triangular portion of the second connector lock 1624 against the second entrance 1524 of the second internal connector interface 1522. A desired exemplary shape of the second entrance 1524 (and the first entrance 1514) is conical, with a cone angle corresponding to the angle of the triangular portion of the second connector lock 1624 that first contacts the entrance 1524 (e.g., it is an acute angle). The conical shape of the entrance 1524 is desired to enable a user to insert the shaft 1612, 1622 into the internal connector interface 1512, 1522 and allow the shaft 1612, 1622 to enter therein, even if the central axis of the shaft 1612, 1622 is slightly misaligned with the central axis of the internal connector interface 1512, 1522. To unlock the connector locks 1614, 1624, the first and second lock release cords 1616, 1618 (see, e.g., Fig. 22 ) are connected to the proximal ends thereof and apply force at the proximal ends of the first and second lock release cords 1616, 1618 to deform and collapse the triangle of the connector locks 1614, 1624, thereby moving the buckle out of the lock apertures 1516, 1526. The lock release cords 1616, 1618 and the lock / unlock controller 2010 together form a lock controller. Fig. 22 As shown, the first and second lock release cords 1616, 1618 approach from opposite sides of the longitudinal axis of the end effector of the delivery device 1600. The crossing of these first and second lock release cords 1616, 1618 holds the delivery cams 1602, 1604 biased toward the central axis in a relatively parallel orientation, and through at least a small crossing angle, the first and second lock release cords 1616, 1618 bias the jaws of the end effector closed.

[0158] Each of the internal connector interfaces 1512, 1522 includes a lock aperture 1516, 1526. As the shaft 1612, 1622 is further inserted into the internal connector interface 1512, 1522, the second connector lock 1624 is deformed (e.g., by collapsing the NiTi wire) within the second internal connector interface 1522 (e.g., Figure 6 As the internal connectors 1610, 1620 are further inserted, the first connector lock 1614 is then deformed within the first internal connector interface 1512. When the internal connectors 1610, 1620 are in the final insertion position within the internal connector interfaces 1512, 1522, the two connector locks 1614, 1624 are longitudinally positioned to expand and snap into the corresponding lock apertures 1516, 1526, which Figure 7 and Figure 8The deformability of connector locks 1614, 1624 is configured so that the surgeon can feel the clamping rods 1510, 1520 being removed from the delivery device 1600 (e.g., technically) but not so strong as to cause significant movement of the clamping rods 1510, 1520 on the tissue compressed between the opposing tissue contacting surfaces of the clamping rods 1510, 1520 during implantation. Another reason for locking the clamping rods 1510, 1520 to the delivery device 1600 is the force that causes the clamping rods 1510, 1520 to expand relative to each other (e.g., as Fig. 9 and Fig.10 The self-locking connection between the delivery device 1600 and the clamping rods 1510, 1520 is not necessarily limited to the inner connector 1610, 1620. The clamping rods 1510, 1520 are not necessarily limited to the inner connector 1610, 1620. The clamping rods 1510, 1520 are not necessarily limited to the inner connector 1610, 1620. The clamping rods 1510, 1520 are not necessarily limited to the inner connector 1610, 1620. The clamping rods 1510, 1520 are not necessarily limited to the inner connector 1610, 1620. The clamping rods 1510, 1520 are not necessarily limited to the inner connector 1610, 1620. The clamping rods 1510, 1520 are not necessarily limited to the inner connector 1610, 1620. The clamping rods 1510, 1520 are not necessarily limited to the inner connector 1610, 1620.

[0159] From the delivery device 1600 and the clamping rods 1510, 1520 (e.g., Figures 4 to 10As can be seen from the exemplary configuration of the embodiment of the present invention, the internal connectors 1610 and 1620 have different lengths. If the lengths of the two internal connectors 1610 and 1620 are the same, it is difficult for the operator / surgeon to visualize that each internal connector 1610 and 1620 enters the corresponding internal connector interface 1512 and 1522. This is particularly true when the visualization is two-dimensional and one of the internal connectors 1610 and 1620 physically blocks the other. It is more difficult to coordinate the insertion of two pins into the corresponding holes at the same time than to insert one at a time. In contrast, when the lengths of the internal connectors 1610 and 1620 are different, as in the exemplary configuration, the operator can position the longer internal connector 1620 at a farther visualization position than the shorter internal connector 1610. As a result, when the operator moves the internal connectors 1610 and 1620 into the internal connector interfaces 1512 and 1522, the longer one can be seen to enter the corresponding internal connector interface, and then the shorter one can be seen to enter its internal connector interface without obstruction. In other words, the operator only needs to align one of the internal connectors 1620 with its corresponding internal connector interface 1522, and with a little insertion, the other internal connector 1610 can be easily aligned to be inserted into its corresponding internal connector interface 1512. The parallel offset of the internal connectors 1610, 1620 and the delivery cams 1602, 1604 by the lock release ropes 1616, 1618 is to position the connectors 1610, 1620 in approximately what appropriate position to make the second internal connector 1620 easy to align, and once the second connector 1620 is partially engaged (e.g., Figure 5 ), which will position the first connector 1610 so as to align with the internal connector interface 1512. Once the clip 1500 is implanted in the tissue, the spacing between the clamp rods 1510, 1520 and the angle between them are determined by the tissue between them. This makes the relative angle variable and requires the connectors 1610, 1620 and the cams 1602, 1604 to be able to change the angle and relative spacing with very light forces so that they can move to match the implanted clip 1500, which makes the connectors 1610, 1620 "free floating" for matching the axes of the clamp rods 1510, 1520 with as low a force as possible. This free floating aspect of the connectors 1610, 1620 and the cams 1602, 1604 is described in more detail below. Therefore, it can be seen that the first internal connector 1610 is a component including the first shaft 1612 and the first connector lock 1614. Similarly, the second internal connector 1620 is a component including the second shaft 1622 and the second connector lock 1624.

[0160] Fig. 8AAnother exemplary embodiment for the interaction between the internal connector interface 1512, 1522 and the internal connectors 1610, 1620 is depicted in FIG. Figures 4 to 8 As shown in FIG. 1 , the first and second internal connectors 1610 and 1620 can only engage the clamping rods 1510 and 1520 in one orientation. Figures 4 to 8 By moving the second locking aperture 1526 in the second internal connector interface 1522 to the same longitudinal position as the first locking aperture 1516 in the first internal connector interface 1512 and by increasing the (blind) hole distance of the first internal connector interface 1512 to at least the length of the longer second axis 1622 of the second internal connector 1620, as Fig. 8A As shown, the delivery device 1600 can be inserted into the inner connectors 1610, 1620 in either orientation (eg, a left-hand approach or a right-hand approach).

[0161] A second exemplary embodiment of an internal clamp lever control mechanism that allows recapture is shown in Figures 12 to 17 All aspects of the institution are similar to Figures 4 to 11 Therefore, some aspects are not repeated here. However, all aspects thereof are incorporated herein in their entirety. Figure 12 to Figure 14 The progress diagram illustrates the installation of a clip including clamp bars 1510, 1520 (for clarity only the clamp bars 1510, 1520 of the clip are shown and all clips described and / or shown herein are applicable to clips having these clamp bars 1510, 1520) ( Figure 12 to Figure 14 ) and the expansion phase ( Figure 14 to Figure 12 ). Fig.12 Both the step of finally disconnecting the clamping rods 1510, 1520 from the delivery device 1600 and the step of connecting the clamping rods 1510, 1520 to the delivery device 1600 are shown. Figures 12 to 15 The development of FIG. 1 illustrates how the clamping rods 1510, 1520 are connected to the first and second internal connectors 1710, 1720, respectively, and inserted into the first and second internal connector interfaces 1532, 1542, respectively. As indicated by the different numbers, the first and second internal connectors 1710, 1720 are different from the first and second internal connectors 1610, 1620, and the first and second internal connector interfaces 1532, 1542 are different from the first and second internal connector interfaces 1512, 1522.

[0162] exist Figures 12 to 17In an exemplary embodiment of the present invention, the first and second internal connector interfaces 1532, 1542 are different from each other. The second internal connector interface 1542 is in the form of a cylindrical, blind hole. Therefore, the second internal connector interface 1542 forms a guide into which the second internal connector 1720 is inserted. When fully inserted, the second internal connector 1720 is slidably resting within the second internal connector interface 1542. In contrast, the first internal connector 1710 is an assembly including a hollow tubular housing 1712, in which a locking plunger 1714 and a biasing device 1716 are housed, which is connected to the proximal end of the plunger 1714 and is based on a proximal position not shown within the tubular housing 1712, wherein the housing is adjacent to and / or within the first delivery cam 1602. Also not shown are control cables (e.g., lock release cables 1616, 1618) having one end secured to the proximal end of plunger 1714 and connected to a lock / unlock control 2010 at handle 2000 of delivery device 1600 (see FIG. Figure 3 ). When actuated, the lock / unlock control 2010 exerts a force on the lock release cables 1616, 1618 to move the plunger 1714 proximally within the tubular housing 1712. The tubular housing 1712 is cross-sectional in 12 to 15 so that the plunger 1714 and the biasing device 1716 are visible in these figures.

[0163] The first internal connector interface 1532 is also a component with multiple parts. The component includes a lock 1534, which is connected to the clamp rod 1510 at the distal end and extends toward the conveying device 1600 in the longitudinal proximal direction. The lock 1534 has a locking surface 1536, which is shaped to enter the corresponding keyhole 1715 of the locking plunger 1714 and lock therein. Due to the cross-section of the tubular shell 1712, the opening 1718 in the tubular shell 1712 is partially shown in these figures. The first internal connector and the second internal connector 1710, 1720 each have an external shape corresponding to the corresponding inner surface of the first internal connector interface and the second internal connector interface 1532, 1542 to match therein. In this article, these external shapes are similar, with a circular cross-section and a rounded tip. However, the shapes of the two internal connectors 1532, 1542 can be different, for example, one is a circular cross-section and the other is a polygonal cross-section. The lock 1534 prevents the clamping rods 1510 , 1520 from sliding off the delivery device 1600 after the first and second inner connectors 1710 , 1720 are inserted into the inner connector interfaces 1532 , 1542 .

[0164] Fig.13 Second internal connector 1720 inserted into second internal connector interface 1542 and first internal connector 1710 not yet inserted into first internal connector interface 1532 are shown. Fig.14 The locking plunger 1714 of the first inner connector 1710 is shown inserted further into the second inner connector interface 1542 and into the proximal portion of the first inner connector interface 1532. In this state, the locking surface 1536 has not yet been inserted into the keyhole 1715. Finally, Fig.15 The locked state of the clip is shown, wherein the second inner connector 1720 is inserted into the second inner connector interface 1542 and the tubular housing 1712 is inserted far enough into the first inner connector interface 1532 to lock the locking surface 1536 into the keyhole 1715 of the locking plunger 1714. With the locking surface 1536 inserted into the keyhole 1715, the clamp rod 1510 (and thus the second clamp rod 1520 connected thereto) is temporarily locked to the delivery device 1600, temporarily meaning that the surgeon can unlock the clamp 1500 to allow implantation of the clamp 1500 when desired. An example of this locked state is shown in FIG. Fig.23 1714. To unlock the clip 1500 from the delivery device 1600, the operator / surgeon actuates the lock / unlock control 2010 at the handle 2000 to apply a proximal force on the locking plunger 1714. The force is greater than the force applied by the lock 1534 on the locking plunger 1714, thereby unlocking the lock 1534. In this particular exemplary embodiment, the locking surface 1536 is curved and / or angled and the lock eye 1715 is curved and / or angled so that when the proximal force is applied to the locking plunger 1714, the lock 1534 bends and the locking surface 1536 slides out of the lock eye 1715. The features of the lock described and shown are merely exemplary and other forms of locking connections are equally possible.

[0165] A third exemplary embodiment of an internal clamp lever control mechanism that allows recapture is shown in Figures 18 to 21 All aspects of the institution are similar to Figures 4 to 17 Therefore, some aspects are not repeated here. However, all aspects thereof are incorporated herein in their entirety. Figures 18 to 20The progress diagram illustrates the installation and deployment stages of a clamp including clamp bars 1510, 1520 (for clarity only the clamp bars 1510, 1520 of the clamp are shown and all clamps described and / or shown herein are applicable to clamps having these clamp bars 1510, 1520). As in other embodiments, the delivery device 1600 includes first and second delivery cams 1602, 1604, which are respectively connected to the clamp bars 1510, 1520. The first and second delivery cams 1602, 1604 are pivotally connected to the first and second internal connectors 1810, 1720 at distal pivots 1603, 1605, respectively, and the first and second delivery cams 1602, 1604 are pivotally connected to the delivery U-clip 1608 at proximal pivots 1806, respectively. A cam-actuated connector, not shown, controls the movement of the delivery cams 1602, 1604 relative to each other (e.g., as shown in FIG. 1 ). Fig. 9 and Fig.10 ). The use of first and second distal pivots 1603, 1605 creates beneficial properties. By allowing the first and second internal connectors 1810, 1720 to freely pivot about a small angle (e.g., between >0° and about 60°, particularly, between about 20° and about 40°, particularly, about 30°), the internal connectors 1810, 1720 are allowed to easily self-align, so that when the second internal connector 1720 is inserted, the first internal connector 1810 can pivot as desired while the second internal connector 1720 remains relatively stationary.

[0166] Fig.18 Both the step of finally disconnecting the clamping rods 1510, 1520 from the delivery device 1600 and the step of connecting the clamping rods 1510, 1520 to the delivery device 1600 are shown. Figures 18 to 20 The development of FIG. 1 shows how the clamping bars 1510, 1520 are connected to the first and second internal connectors 1810, 1720, respectively. As indicated by the different numbers, the first internal connector 1810 is different from the first internal connectors 1610, 1710 and the first internal connector interface 1912 is different from the first internal connector interfaces 1512, 1532. Figures 18 to 20In an exemplary embodiment of the invention, the first and second internal connector interfaces 1912, 1542 are different from each other. The second internal connector interface 1542 is in the form of a cylindrical, blind hole. Thus, the second internal connector interface 1542 forms a guide into which the second internal connector 1720 is inserted. When fully inserted, the second internal connector 1720 is slidably resting within the second internal connector interface 1542. In contrast, the first internal connector 1810 is an assembly including a hollow tubular housing 1812 in which a locking plunger 1814 and a biasing device 1716 are housed, the biasing device being connected to the proximal end of the plunger 1814 and based at a proximal position not shown within the tubular housing, wherein the housing 1812 is adjacent to and / or within the first delivery cam 1602. The lock control cord 1816 is fixed at one end to the proximal end of the locking plunger 1814 and is connected to a lock / unlock controller 2010 at the handle 2000 of the delivery device 1600. When actuated, the lock / unlock control applies a force on the lock control cable 1816 to move the plunger 1814 proximally within the tubular housing 1812 against the force of the biasing device 1716, which is a spring in the exemplary embodiment shown. Figures 18 to 20 The illustrations are cross-sectional so that the plunger 1814 and the biasing device 1716 are visible in these views.

[0167] In this exemplary embodiment, the clamping rods 1510, 1520 have corresponding inner connector interfaces 1912, 1542, here in the form of substantially cylindrical blind holes. The first inner connector 1810 is an assembly including a tubular housing 1812, a locking plunger 1814, a biasing device 1716, a lock control rope 1816 and a curved rope lock 1818. The second inner connector 1720 is a cylindrical shaft, whose outer shape corresponds to the second inner connector interface 1542 to match therein. Here, the outer shape of the first and second inner connectors 1810, 1720 is similar, being a cylinder with a circular cross-section and a rounded tip. However, the shapes of the two connectors 1810, 1720 can be different, for example one with a circular cross-section and one with a polygonal cross-section.

[0168] If the second internal connector 1720 is simply inserted into the second internal connector interface 1542, there is a possibility that the second internal connector 1720 will slip out. In order to hold the clamp rods 1510, 1520 on the delivery U-clip 1608, the first internal connector 1810 has a bend cord lock 1818 (here in the exemplary form of a bend wire). The bend wire is formed of a deformable material (such as Nitinol or another nickel-titanium alloy) and acts as a "one-way" clasp. The clasp is considered to be one-way because it allows the first internal connector 1810 to be easily inserted into the first internal connector interface 1912 (the clasp bends for insertion) but prevents the first internal connector 1810 from being removed from the first internal connector interface 1912 until a given amount of force is overcome. More specifically, with respect to removing the first internal connector 1810 from the first internal connector interface 1912, Figures 18 to 20 To removably capture the clip onto the delivery device 1600, the first and second internal connectors 1810, 1720 are slid into the first and second internal connector interfaces 1912, 1542. Fig.19 1922, the inner connector 1810, 1720 is in an intermediate insertion position. Here, the tubular housing 1812 is within the first inner connector interface 1922, enough to place the curved cord lock 1818 proximal to the first entrance 1914 of the first inner connector interface 1912. The ideal ramp shape of the first and second entrances 1914, 1524 is conical. The conical shape of the entrances 1914, 1524 is desirable to enable a user to insert the inner connector 1810, 1720 into the inner connector interface 1912, 1542 and allow the inner connectors 1810, 1720 to enter therein even if their central axes are slightly misaligned with the central axes of the inner connector interfaces 1912, 1542.

[0169] The first inner connector interface 1912 includes a lock aperture 1916. As the tubular housing 1812 is further inserted into the first inner connector interface 1912, the bend cord lock 1818 is deformed (e.g., by collapsing the NiTi wire) within the first inner connector interface 1912 (the collapse is not shown). As the inner connectors 1810, 1720 are further inserted to align the bend cord lock 1818 with the lock aperture 1916, the bend cord lock 1818 rebounds from its deformation within the lock aperture in the final insertion position of the inner connectors 1810, 1720, as shown. Fig. 20As shown. The deformability of the curved cord lock 1818 is configured so that the surgeon can feel the first internal connector 1810 being removed from the delivery device 1600 (for example) but not so strong as to cause significant movement of the clamping rods 1510, 1520 on the tissue compressed between the opposing tissue contacting surfaces of the clamping rods 1510, 1520 during implantation. As described above, the reason for locking the clamping rods 1510, 1520 to the delivery device 1600 is to prevent the clip 1500 from slipping off the delivery device 1600. One of the significant benefits of having a self-locking connection between the delivery device 1600 and the clamping rods 1510, 1520 is that the user does not need to actuate anything at the proximal end of the delivery device (e.g., pull a trigger or slide a slider) to lock the clip 1500 to the delivery device 1600, which is particularly beneficial during recapture for reimplantation. In short, simply by sliding the inner connector 1810 , 1720 into the clamping bars 1510 , 1520 , the clamping bars 1510 , 1520 are automatically locked to the delivery device 1600 .

[0170] at last, Fig. 20 The locked state of the clip 1500 is shown, wherein the first inner connector 1810 is inserted into the first inner connector interface 1912 so as to position the tubular housing 1812 far enough to lock the curved cord lock 1818 into the lock aperture 1916. With the curved cord lock 1818 inserted into the lock aperture 1916, the first clamping bar 1510 (and thus the second clamping bar 1520 connected thereto) is temporarily locked onto the delivery device 1600. To unlock the clip 1500 from the delivery device 1600, the operator / surgeon actuates the lock / unlock control 2010 at the handle 2000 to exert a proximal force on the lock control cord 1816. This force is greater than the force exerted by the curved cord lock 1818 at the lock aperture 1916, thereby unlocking the curved cord lock 1818. The features of the lock described and shown are merely exemplary and other forms of locking connections are equally possible.

[0171] Various exemplary embodiments of locking a clip to a delivery device have been described. Alternative embodiments include Figure 72 to Figure 74 In this exemplary embodiment, at least one of the inner connectors 7200 has a barbed feature that engages a lock on a clamping bar (e.g., 1510, 1520), which is in a state where Fig.72Schematically shown in FIG. A jaw controller, not shown, is connected to the jaws, which applies a minimal preloaded opening force on the first and second internal connectors 7200 that engage the barb features on the lock 7210. This barb lock engagement substantially prohibits release of the clip until proper clip placement is achieved. Once the surgeon is satisfied with the placement of the clip, the jaw controller can relax the preloaded opening force on the first and second internal connectors 7200, as shown in FIG. Fig.73 , thereby releasing the barb from the lock 7210 and allowing the clip to disengage from the end effector as shown schematically in FIG. Fig.74 shown.

[0172] Additional exemplary embodiments of locking the clip to the delivery device include expansion chucks, balloons, and splice cuts. In the expansion chuck or balloon embodiment, the internal connector includes an expansion structure, an opening structure, or other shape-changing structure that engages the internal connector interface by friction or by mechanical interference between tight components. This is not limited to friction on soft surfaces, and the internal connector interface or internal connector can have a locking feature that engages when expanded. In one exemplary embodiment, the internal connector is an expansion pin that opens inside the internal connector interface, thereby providing sufficient resistance to the clip being disengaged. In another exemplary embodiment, the internal connector is a balloon that can be expanded within the internal connector interface, thereby providing sufficient resistance to the clip being disengaged. In yet another exemplary embodiment, the internal connector has a splice cut. When inside the internal connector interface, the lock control rope can be actuated to cause lateral movement of the internal connector splice cut, thereby generating sufficient resistance to the clip being disengaged. Another exemplary embodiment of the locking feature includes the use of magnetic material. In this exemplary embodiment, the internal connector has a lock control rope attached to the lock control rope, which is biased by a biasing member (e.g., such as Figures 12 to 20 The clamp rod has a magnetic component or feature within the internal connector interface. The magnet of the internal connector then applies a magnetic force to the magnetic component or feature within the internal connector interface, thereby providing sufficient resistance to the clip's disengagement without requiring user action. The actuation lock control rope retracts the internal magnet, thereby sufficiently weakening the magnetic force between the magnet and the magnetic component, thereby enabling the clip to disengage. In another exemplary embodiment, the connector can engage the outer surface of the clamp rod. The locking feature and the connector interface can then be internal and / or external.

[0173] Figure 23 to Figure 28 An exemplary embodiment of a clip 1500 attached to an end effector of a delivery device 1600 is shown in various implanted states on the LAA 20. Fig.23 In FIG. 1 , the clip 1500 is closed and close to the implantation site at the base of the LAA 20. Fig.24 In FIG. 1 , the clip 1500 is open and close to the implantation site at the base of the LAA 20. Fig.25 , the clip 1500 is open and surrounds the base of the LAA 20. Fig.26 In FIG. 1 , the clip 1500 is closed down over the base of the LAA 20 but remains attached to the delivery device 1600. Fig. 27 , the clip 1500 has been released from the delivery device 1600 and is closed over the base of the LAA 20, but the internal connectors remain within the internal connector interfaces of the clamp bars 1510, 1520. Fig.28 In the embodiment of the present invention, the clip 1500 is implanted at the base of the LAA 20 and the delivery device 1600 is completely disengaged from the clip 1500. If the implantation is as desired, the procedure is complete. However, if a different implantation orientation is desired, the internal connector can be reinserted into the internal connector interface and the clip 1500 can be removed and repositioned on the LAA 20. These steps can be repeated until satisfactory implantation of the clip 1500 is achieved.

[0174] It should be noted that recapturing the clip 1500 from the LAA 20 may cause some difficulty for the surgeon because the arms 1510, 1520 of the implanted clip 1500 may not only become separated from one another (as in, for example, Figures 18 to 21 1500) and the clamping rods 1510, 1520 may also be non-parallel to each other (for example, when the tissue clamped between the clamping rods 1510, 1520 is uneven). It is common to have spacing and non-parallelism after the clamp 1500 is implanted. Embodiments of the delivery device 1600 overcome this obstacle through the exemplary construction of cams 1602, 1604, internal connectors 1610, 1620, 1710, 1720, 1810 and pivots 1603, 1605, 1606, 1607, 1806 that connect these structures and allow them to move relative to each other. To explain how these parts allow the internal connectors to move independently to align with the internal connector interface in the clamping rod, refer to Figure 29 to Figure 33 The cam slots in the delivery cams 1602, 1604 are shaped and spaced from the pivots 1603, 1605 to provide less mechanical advantage at the beginning of the travel as the two cams 1602, 1604 begin to separate and to provide significantly more mechanical advantage in the middle and end of the travel as the two cams 1602, 1604 further separate. More specifically, as Fig.29As shown, the trigger 2020 is actuated to initiate jaw opening actuation of the cams 1602, 1604. The trigger 2020 is connected to the cam block 2024 by the jaw control rope 2022, and when moved proximally in this exemplary embodiment, the cam block applies a force to the cams 1602, 1604 at an angle α about the pivots 1603, 1605. Because this angle is relatively large, the longitudinal force is relatively small. However, as the trigger 2020 is further actuated to move the cam block 2024 further proximally, the force applied to the cams 1602, 1604 about the pivots 1603, 1605 is now at an angle β. Because this angle is relatively small, most of the mechanical advantage is in the longitudinal direction, and therefore the longitudinal force is relatively large. (The progression from the closed state to the intermediate open state and then to the open state is in Figure 31 to Figure 33 . ) Thus, in the closed position when the angle is relatively large (e.g., α), any lateral force acting on the distal tip of any one of the connectors 1610, 1620, 1710, 1720, 1810 can relatively easily move the distal tip. In other words, a user placing their finger on the tip of one of the connectors 1610, 1620, 1710, 1720, 1810 can relatively easily cause the connector and cam to pivot about the pivot (a feature explained below). Figures 34 to 38 In contrast, as cams 1602, 1604 rotate further about pivots 1603, 1605, the amount of force to move the tip laterally increases significantly. Another way to describe this function of delivery device 1600 is that the first opening movement of cams 1602, 1604 only requires opening the proximal end of the clamp rod (see Fig.32 ), and thus this opening portion requires only half the total load. Therefore, the tracks of the cams 1602, 1604 in which the actuating pin runs are configured so that the mechanical advantage is small at the beginning of the movement when the load is small. In contrast, the mechanical advantage is greater at the end of the movement when the load is greatest (see Fig.33 ) because the entire clamping rod 1510, 1520 is separated. By having a lower mechanical advantage in the first part of the movement, there is the ability to "back drive" the system by applying an expansion force to the cams 1602, 1604. When the cams 1602, 1604 are closest, the force required to open the cams 1602, 1604 is at its lowest point. This allows the operator to easily move the cams 1602, 1604 to match the width of the tissue disposed within the clamping rods 1510, 1520 when recapture. This can be achieved by the overall movement of the U-shaped clamp 1608 away from the clamping rod 1520 that has been engaged with the longer connector 1620 and toward the other clamping rod 1510. This movement is Figures 34 to 38 The progress of Fig.34In the embodiment of the present invention, the clip 1500 is implanted at the base of the LAA 20 and removal and / or re-implantation is desired. Therefore, the surgeon inserts the distal tip of the second internal connector 1620 into the clamp rod 1520. At this point, the surgeon can use it as a fulcrum to move the U-shaped clamp 1608 in a unitary motion to align the first internal connector 1610 with the first clamp rod 1510 first internal connector interface 1512. Fig.35 As shown, the surgeon has applied a force ( Fig.35 1604) to pivot the second internal connector 1620 and the second delivery cam 1604 clockwise, thereby moving the distal tip of the second internal connector 1620 away from the distal tip of the first internal connector 1610. In this example, the clamping rods 1510, 1520 are intentionally non-parallel. Therefore, once the second internal connector 1620 is in place in the clamping rod 1520, the first internal connector 1610 is not aligned with the axis of the first internal connector interface 1512. With Fig.36 , the surgeon rotates the U-clip 1608 to align the distal tip of the first internal connector 1610 with the internal connector interface of the first clamping rod 1510 (see FIG. Fig.37 ). The surgeon then pushes the U-shaped clamp 1608 distally toward the clamp rods 1510, 1520, and the inner connectors 1610, 1620 naturally slide into the corresponding inner connector interfaces 1512, 1522 as the parts rotate about the corresponding pivots 1603, 1605, 1606, 1607. Fig.38 As shown, as the U-shaped clip 1608 moves further distally, the internal connectors 1610, 1620 fully enter the corresponding internal connector interfaces 1512, 1522 and the connector locks 1614, 1624 lock the delivery device 1600 to the clamp rods 1510, 1520. With this locking, the clip can be opened and removed or repositioned on the LAA 20 as desired by the surgeon.

[0175] In another exemplary embodiment of the clip, see Fig.39 and Fig.40, the biasing member 2030 can be attached to the clamping rod 2040, 2050 by geometric features (e.g., a 90 degree bend of the spring that engages with the hole 2042, 2052 in the clamping rod and the associated protrusion 2044, 2054). The protrusion 2044, 2054 overlaps the hole 2042, 2052 so that the biasing spring 2030 needs to be expanded to be inserted, so that the biasing spring 2030 will continue to be retained by the protrusion 2044, 2054 when the biasing load is applied. This enables a torsionally rigid connection between the biasing member 2030 and the clamping rod 2040, 2050 without the use of secondary inhibition or mechanical retention attachment, thereby reducing the number of parts and costs and simplifying the implant. This construction reduces materials, number of parts, and failure modes.

[0176] Figures 41 to 52 Another exemplary configuration of a clip 2100 is shown. Figures 41 to 52 A clip 2100 is shown in which a biasing device 2130 is present on both the top and bottom of the clamping rods 2110, 2120. As used herein, top and bottom (as well as upper and lower) are used only to distinguish between opposite sides of the clamping rods 2110, 2120. The use of top and bottom does not mean that the top side of one of the clamping rods 2110, 2120 must be the top of the structure placed on it. In an example of implanting the clip 2100 in the LAA, the bottom side of the clamping rods 2110, 2120 can be placed on the surface of the heart adjacent to the left atrium, while the top side faces away from the left atrium and extends away from the heart from above the clip 2100 along and / or against some tissue of the LAA. In this exemplary embodiment, the first, second, third and fourth biasing anchors or biasing device connectors 2114, 2124, 2115, 2125 are integral with the clamping rods 2110, 2120. The biasing devices 2130 are not secured to the clamping bars 2110, 2120 by external means (e.g., separate clips or anchors), but rather wrap around various fixing points on the clamping bars 2110, 2120, including the first through fourth biasing connectors 2114, 2124, 2115, 2125. Therefore, the biasing devices 2130 may be referred to as self-fixing, meaning that no structure other than the clamping bars 2110, 2120 is required to fix the biasing devices 2130 to the clamping bars 2110, 2120. In an exemplary embodiment, after being bent around the fixing points on the clamping bars 2110, 2120, the ends of the upper and lower biasing devices 2130 are presented within the biasing ports 2112, 2122, 2113, 2123 on both sides of each of the clamping bars 2110, 2120. For example, the biasing devices 2130 may be provided at the bottom of the clamping bars 2110, 2120. Fig.42 and Fig.43 The cross section and Fig.44 and Fig.45 The bias ports 2112, 2122, 2113, 2123 are seen in the plan view.

[0177] Especially about Fig.43 , so the upper biasing device 2130 starts from the biasing port 2112 in an upward direction (relative to Fig.42 ) and bends approximately 90° in the longitudinal direction toward the proximal end of the clamp 2100. The upper biasing device 2130 then rests against the first biasing connector 2114 and passes underneath it and travels toward the proximal end of the first clamp bar 2110. (As used herein, the term "resting against" does not mean that the upper biasing device 2130 must rest on top of the upper surface of the first clamp bar 2110. The upper biasing device 2130 can rest against the surface, or can be at a certain distance therefrom (adjacent), or portions thereof can be in contact with other portions at a certain distance therefrom.) Before the proximal end of the first clamp bar 2110 or after the proximal end of the first clamp bar 2110 (the latter example is shown), the upper biasing device 2130 makes a bend 2132 of approximately 180° in the lateral direction to leave the vicinity of the first clamp bar 2110 and enter the vicinity of the second clamp bar 2120. The upper biasing device 2130 travels longitudinally in the distal direction away from the proximal end of the second clamping rod 2120 and passes against and under the second biasing connector 2124. The upper biasing device 2130 then bends inwardly approximately 90° into the biasing port 2122 and terminates within the biasing port 2122, as shown in FIG. Fig.43 and Fig.44 shown.

[0178] The lower biasing device 2130 starts from the biasing port 2113 in a downward direction (relative to Fig.42 / 168) and bends approximately 90° in the longitudinal direction toward the proximal end of the clamp 2100. The lower biasing device 2130 then passes against and under the third biasing connector 2115 and advances toward the proximal end of the first clamp rod 2110. Before the proximal end of the first clamp rod 2110 or after the proximal end of the first clamp rod 2110 (the latter example is shown), the lower biasing device 2130 makes a bend 2132 of approximately 180° in the lateral direction to leave the vicinity of the first clamp rod 2110 and enter the vicinity of the second clamp rod 2120. The lower biasing device 2130 advances longitudinally away from the proximal end of the second clamp rod 2120 in the distal direction and passes against and under the fourth biasing connector 2125. The lower biasing device 2130 then bends inwardly approximately 90° into the bias port 2123 and terminates within the bias port 2123, as shown. Fig.43 shown.

[0179] Fig.51 and Fig.52An exemplary embodiment of the terminal end of the lower biasing device 2130 within the biasing port 2123 of the clamping rod 2120 is depicted. As can be seen in this example, the biasing port 2123 is not a blind hole, but rather passes completely through the clamping rod 2120 and terminates within the path of the upper biasing device 2130 after the upper biasing device 2130 exits the biasing port 2122. Therefore, by appropriately selecting the length of the terminal portion after the 90° transverse bend, the distal end 2134 will press against the upper biasing device 2130 (see Fig.51 and Fig.43 ), thereby generating a force that presses the upper biasing device 2130 against the lower side of the second biasing anchor 2124 and helps to keep the upper biasing device 2130 in place. This construction can also be set Fig.42 In the first clamping rod 2110 shown in . As an alternative, the biasing ports can be blind holes, wherein the corresponding ends of the biasing device 2130 terminate in these blind holes.

[0180] As described above, in order to maintain a minimal cross-section throughout the LAA clip implantation process, an exemplary embodiment of the delivery device 1600 for implanting the clips 1500, 2100 is configured to grasp the clip rod from the corresponding internal hollow portion. This configuration also applies to the clip 2100. For example, Fig.47 As shown, each of the clamp rods 2110, 2120 has a corresponding internal hollow portion 2116, 2126. When the exemplary embodiment of the delivery device 1600 is used for implantation, the distal internal connectors 1610, 1620, 1710, 1720 of the delivery device 1600 are inserted into the internal hollow portions 2116, 2126 of the clamp rods 2110, 2120 to temporarily fix and control the movement and delivery of the clip 2100. In order to cooperate with the distal internal connectors 1610, 1620, 1710, 1720 of the delivery device 1600, the clamping rods 2110, 2120 are completely hollow, or the clamping rods 2110, 2120 have a blind hole that starts from the proximal end of each of the clamping rods 2110, 2120 and passes through the clamping rods 2110, 2120 to an internal distance sufficient to allow controlled separation between the two clamping rods 2110, 2120 and control the yaw of the clamping rods 2110, 2120 relative to each other.

[0181] The clip 2100 is accessed and controlled from the interior of the clip 2100 rather than from the exterior of the clip 2100 by a delivery device (e.g., device 1600), which is sized to have a cross-sectional area equal to or less than the maximum cross-sectional diameter of the clip 2100. This means that when the clip 2100 is in use, the width of the port is minimized to the maximum cross-sectional diameter of the clip 2100 rather than the diameter of the delivery device.

[0182] The upper biasing device and the lower biasing device 2130 form a biasing assembly that connects the first clamping bar 2110 to the second clamping bar 2120 to align the first and second clamping bars 2110, 2120 in a clamping bar plane, wherein the plane passes through the tissue contacting surfaces 2118, 2128. In this way, the upper biasing device and the lower biasing device 2130 allow the first and second clamping bars 2110, 2120 to move in the clamping bar plane, for example, to Figure 23 to Figure 28 ,from Figure 29 to Figure 33 and from Figures 35 to 38 Another way to describe this control is to configure the biasing assembly to allow biasing movement of the first and second clamping bars 2110, 2120 in the clamping bar plane. The biasing movement of the first clamping bar 2110 in the clamping bar plane can be independent of the biasing movement of the second clamping bar 2120 in the clamping bar plane.

[0183] Due to the position of the biasing assembly, the upper and lower biasing devices 2130 balance the forces so that the first and second clamping bars 2110, 2120 undergo substantially no rotation about the respective longitudinal axes when the first and second clamping bars 2110, 2120 move in the clamping bar plane. The upper and lower biasing devices 2130 balance the forces so that the first and second clamping bars 2110, 2120 undergo substantially no torque when the first and second clamping bars 2110, 2120 move in the clamping bar plane.

[0184] As described above, the clips described herein, including clip 2100, are, for example, sized to fit within a laparoscopic port having an inner diameter. In this regard, the first and second clamp rods 2110, 2120 and the biasing assembly 2130 together have a maximum outer width that is no greater than the inner diameter of the port. An exemplary embodiment of a port into which the clip 2100 may be inserted is a 10 mm thoracoscopic port (30 French). Thus, the clip 2100 is capable of being assembled within a port for thoracoscopic delivery to the LAA during a clip implantation procedure. More specifically, with respect to Fig.46 and Fig.47 , the outer surfaces of the first and second clamping rods 2110, 2120 define a circle 2140 in the cross-sectional plane and the circle 2140 has an outer diameter. The biasing device 2130 traverses portions of the clamping rods 2110, 2120 while remaining substantially within the outer diameter so that movement of the clip 2100 within the port is unimpeded. Thus, the end effector 1601, 2301 of the delivery device 1600, 2300 has an outer diameter no greater than the clip 2100 to allow the entire system to move within a port having an inner diameter of, for example, approximately 10 mm.

[0185] Regarding the longitudinal length of the upper biasing device and the lower biasing device 2130, for example Fig.48As shown, the first and second clamping bars 2110, 2120 have a maximum longitudinal length L (parallel to the longitudinal axis of the clamping bars 2110, 2120) and the upper and lower biasing devices 2130 have a longitudinal length shorter than the maximum longitudinal length; see also Figure 41 to Figure 45 .

[0186] Figure 53 to Figure 65 The construction shown in illustrates another exemplary embodiment of a LAA clip 2200 having clamp bars 2210, 2220 and features applicable to any of the clips described and / or depicted herein. Figure 53 to Figure 65 A clamp 2200 is shown in which a biasing device 2230 is present on both the top and bottom of the clamp bars 2210, 2220. Figure 53 to Figure 65 In the configuration of the clip 2200, for clarity and other reasons, the biasing device 2230 is shown in cross-section, wherein the cross-section is cut at the centerline 2231 of the biasing device 2230 (for both the upper biasing device 2230 and the lower biasing device 2230), and therefore, the biasing device 2230 is depicted only on one side of the clip 2200 in each of the figures. In particular, in Fig.53 , Fig.55 , Fig.58 , Fig.59 , Fig.60 and Fig.62 , the biasing device 2230 is shown as half surrounding the clamping rod 2220, and Fig.54 , Fig.56 , Fig.57 , Fig.61 , Fig.63 , Fig.64 and Fig.65 , half of the biasing device 2230 is shown surrounding the clamping rod 2210. It should also be noted that the upper and lower biasing devices 2230 are depicted as extending through the sides of the clamping rods 2210, 2220, for example, through Fig.54 The left side of the clamp rod 2210 (as viewed from its proximal end) and passes through Fig.55 The left side of the middle clamping rod 2220 (as viewed from its distal end). Figure 53 to Figure 65 The extensions of the upper and lower biasing means 2230 in FIG. 2 do not exist on the actual LAA clip 2200. This depiction merely illustrates the preload present in the springs of the upper and lower biasing means 2230 to create a bias that forces the two clamping rods 2210, 2220 toward / against each other even when no tissue is disposed therebetween. Thus, in particular, in FIG. Fig.58 As can be seen in the cross-section, the centerline 2231 of the upper and lower biasing devices 2230 is not aligned with the central longitudinal axis 2202. However, in the configuration of the LAA clip 2200, in the LAA clip 2200 (e.g., Fig.58 and Fig.59 In the stable state (the one depicted in FIG. 1 ) and as long as the force separating the two clamping bars 2210, 2220 is similar for each of the clamping bars, the centerline 2231 of the upper and lower biasing devices 2230 remains aligned with the central longitudinal axis 2202; in other words, if there is a force applied to one clamping bar while the other clamping bar remains stationary, or if the force on one clamping bar is different from the force on the other clamping bar, the centerline 2231 of the upper and lower biasing devices 2230 will not be aligned with the central longitudinal axis 2202. The portion of the biasing device 2230 not depicted is a mirror image of the portion depicted.

[0187] As used herein, top and bottom (and upper and lower) are as defined above, and the use of top and bottom does not mean that the top side of the clamp bars 2210, 2220 must be the top of the structure placed on it. In one example of implanting the clip 2200 in the LAA, the bottom side of the clamp bars 2210, 2220 can rest on the surface of the heart adjacent to the left atrium, while the top side faces away from the left atrium and extends from above the clip 2200 away from the heart along and / or against some tissue of the LAA.

[0188] The first, second and third biasing anchors or biasing device connectors 2214, 2215, 2216 at the clamp bar 2210 and the fourth, fifth and sixth biasing anchors or biasing device connectors 2224, 2225, 2226 at the clamp bar 2220 are in this exemplary embodiment integral with the respective clamp bars 2210, 2220. As in the previous exemplary embodiments, the biasing device 2230 is not secured to the clamp bars 2210, 2220 by external means (e.g., a clip or anchor), but rather surrounds various fixing points on the clamp bars 2210, 2220, including the first to sixth biasing connectors 2214, 2215, 2216, 2224, 2225, 2226. In an exemplary embodiment, the ends of the upper and lower biasing devices 2230 are presented within biasing ports 2212, 2213, 2222, 2223 in the clamping bars 2210, 2220 after being bent around these fixing points on the clamping bars 2210, 2220. For example, Fig.57 and Fig.65 The cross section and Fig.57 and Fig.64 The bias ports 2212, 2213, 2222, 2223 are seen in the perspective view.

[0189] Thus, the upper biasing device 2230 is connected from the upper biasing port 2212 (see Fig.57) and in the proximal direction (relative to Fig.57 Continuing, the upper biasing device 2230 surrounds and abuts against the first biasing device connector 2214 (relative to the left side) in the lateral direction toward the top side of the clamp rod 2210. Fig.57 The upper biasing device 2230 is then bent through another approximately 90° angle (relative to Fig.57 The upper biasing device 2230 is then extended toward the proximal end of the first clamping bar 2110 (e.g., toward the proximal end of the first clamping bar 2110). Fig.57 Before the offset end 2211 of the first clamping rod 2210 (for example, Fig.60 and Fig.61 2200) or after the proximal end of the first clamping rod 2210, the upper biasing device 2230 is bent 2232 by about 180° in the lateral direction to leave the vicinity of the first clamping rod 2210 and enter the vicinity of the second clamping rod 2220 (see, for example Fig.58 The bend 2232 that terminates prior to the offset ends 2211, 2221 of the clamping bars 2210, 2220 is an exemplary feature that ensures that when the compressed LAA tissue between the clamping bars 2210, 2220 is squeezed to extend beyond the biasing device 2230 (if such a situation occurs), there is still material of the clamping bars 2210, 2220 available to contact the LAA tissue.

[0190] The upper biasing device 2230 travels longitudinally in the distal direction away from the biasing end 2221 of the second clamping rod 2220 and passes against and around the fifth biasing connector 2225 (see, e.g. Fig.56 ; This part of the upper biasing device 2230 is Fig.56 The upper biasing device 2230 then bends inwardly approximately 90° into and between the fourth biasing device connector 2224 and the fifth biasing device connector 2225, and then bends approximately 90° toward the upper biasing port 2222 and terminates within the upper biasing port 2222 in the second clamping rod 2220. The wall 22266 at the distal end of 2226 also helps to hold the bent portion 2238 of the biasing device 2230 in place.

[0191] about Fig.61In contrast, the lower biasing device 2230 starts from the lower biasing port 2213 and extends in the distal direction (relative to Fig.61 Upward). The lower biasing device 2230 abuts against and bends about 180° (2234) in the lateral direction toward the lower side of the first clamping rod 2210 around the third biasing device connector 2216. The lower biasing device 2230 then abuts against and / or extends along and below the third biasing device connector 2216 and along the first clamping rod 2210 toward the biased end of the first clamping rod 2210. (As above, the term abutting does not mean that the lower biasing device 2230 must contact the lower side of the first clamping rod 2210. The lower biasing device 2230 can rest against the surface, or can be at a certain distance therefrom (adjacent), or portions thereof can be in contact with other portions at a certain distance therefrom.) In this exemplary embodiment (as in Fig.60 and Fig.61 ), the lower biasing device 2230 extends to just before the biasing end 2211 of the first clamping bar 2210 (alternatively, it can extend through the biasing end 2211 of the first clamping bar 2110). The lower biasing device 2230 makes a bend 2236 of about 180° in the lateral direction to leave the vicinity of the first clamping bar 2210 and enter the vicinity of the second clamping bar 2220, such as from Figure 61 to Figure 60 The lower biasing device 2230 then moves from the biasing end 2211 in the proximal direction (relative to Fig.60 The lower biasing device 2230 then abuts against and bends 2238 inwardly about 180° around the sixth biasing device connector 2226 into the lower biasing port 2223 and terminates in the lower biasing port 2223 (e.g., Fig.53 2216). The wall 22166 at the distal end of the biasing device 2230 also helps to hold the curved portion 2234 of the biasing device 2230 in place.

[0192] Fig.56An exemplary embodiment of the location of the terminal ends of the upper and lower biasing devices 2230 within the upper and lower biasing ports 2222, 2223 of the clamping rod 2220 is depicted (the ports 2212, 2213 of the clamping rod 2210 are similar). As can be seen in this exemplary configuration, the upper and lower biasing ports 2212, 2213, 2222, 2223 are not blind holes, but have an entrance and an exit at the respective clamping rods 2210, 2220 and each path terminates within the path through which the other biasing device passes. Therefore, by the selected length of the terminal portion of each of the upper and lower biasing devices 2230, the farthest end can be designed to press against a portion of the other biasing device (e.g., each upper biasing device end can press against a portion of the lower biasing device and each lower biasing device end can press against a portion of the upper biasing device). This connection can be used to apply force to the other biasing device to help maintain the upper and lower biasing devices 2230 in place on the clip 2200. As an alternative, the selected length of one or both of the end portions of each of the upper and lower biasing devices 2230 can be sized to not contact a portion of the corresponding other biasing device. In another alternative, the upper and lower biasing ports 2212, 2213, 2222, 2223 can be blind holes, not shown.

[0193] As described above, in order to maintain a minimal cross-section throughout the implantation of the LAA clip 2200, an exemplary embodiment of a delivery device 1600 that can be used with clips (e.g., 1500, 2100) is configured to grasp the clamp rod from the corresponding internal hollow portion. This configuration also applies to the clip 2200. For example, Fig.54 As shown, each of the clamp rods 2210, 2220 has a corresponding internal hollow portion 2218, 2228. When the exemplary embodiment of the delivery device 1600 is used to implant the clip 2200, the distal internal connectors 1610, 1620 of the delivery device 1600 are inserted into the internal hollow portions 2218, 2228 of the clamp rods 2210, 2220 to temporarily fix and control the movement and delivery of the clip 2200. In order to cooperate with the internal connectors, 1610, 1620 of the delivery device 1600, the clamping rods 2210, 2220 can be through holes, or the clamping rods 2210, 2220 can have blind holes that start from the proximal end of each of the clamping rods 2210, 2220 and pass through the clamping rods 2210, 2220 to an internal distance sufficient to allow controlled separation between the two clamping rods 2210, 2220 and control the deflection of the clamping rods 2210, 2220 relative to each other (this deflection control is described in detail above). Fig.57 An exemplary embodiment of a blind hole configuration of the interior hollow portion 2218 of the first clamping rod 2210 is depicted in FIG. Fig.57Also depicted are lock apertures 1516, 1916 shaped to accommodate entry and temporary locking of a connector lock 1614, 1818 of a corresponding one of the embodiments of the internal connectors 1610, 1620, 1710, 1720 of the delivery device 1600 (see, e.g., Figures 4 to 6 and Figures 18 to 20 ).

[0194] Figures 66 to 69 Another exemplary embodiment of a delivery device 2300 for controlling, implanting, removing, and reimplanting one of the clips (e.g., 1500, 2100, 2200) is illustrated, in which the clip 2200 is mounted on an end effector 2301 of the delivery device 2300. Figure 66 to Figure 69 The progress of FIG. 1 shows the installation and implantation stages of the clip 2200 , wherein the clip includes clamp rods 2210 , 2220 and upper and lower biasing devices 2230 . Fig.66 The steps of first connection and final disconnection of the clip 2200 to the clamp rods 2210, 2220 of the delivery device 2300 are shown and the clip 2200 is also shown removed from the LAA for re-implantation after the surgeon has decided to reposition the clip 2200, for example. Fig.67 An intermediate step of opening the clamp bars 2210, 2220 of the clamp 2200 with the delivery device 2300 is shown, but before the distal tips 2219, 2229 of the clamp bars 2210, 2220 are moved away from each other. Fig.67 Also demonstrated in making the clip 2200 back Fig.66 An intermediate step of closing the clamp 2200 before reaching a stable state. Fig.66 Only the upper biasing device 2230 is shown, but Fig.67 An upper biasing device and a lower biasing device 2230 are shown. Fig.68 Intermediate steps of opening and closing the bars 2210, 2220 of the clip 2200 are shown, and at a position not shown after the clip 2200 has been implanted on the LAA, e.g., just before the bars 2210, 2220 are finally disconnected from the delivery device 2300 to complete the implantation of the clip 2200. Finally, Fig.69An intermediate step is shown for fully opening the bars 2210, 2220 of the clip 2200 to a position where the clip 2200 can be manipulated, for example, to open on both sides of the LAA. It can be seen that the position of the upper and lower biasing devices 2230 allows a large opening only at the biasing ends 2211, 2221 of the bars 2210, 2220 to engage the LAA and slide the clip 2200 horizontally along and / or vertically down the LAA to use the 180° bend 2232 of the upper biasing device 2230 and the 180° bend 2236 of the lower biasing device 2230 as a stop or backstop to prevent further longitudinal movement of the LAA located therebetween in a proximal direction.

[0195] The end effector 2301 of the delivery device 2300 includes first and second delivery cams 2302, 2304. The first and second delivery cams 2302, 2304 are pivotally connected to first and second internal connectors 2310, 2320 at their distal ends at distal pivots 2303, 2305, respectively, and the first and second delivery cams 2302, 2304 are pivotally connected to a delivery U-clip 2308 at each of first and second proximal pivots 2306, 2307, respectively. The cam-actuated connector, not shown, controls the movement of the delivery cams 2302, 2304 relative to each other (e.g., as shown in FIG. 2 ). Fig.66 and Fig.69 The use of the first and second distal pivots 2303, 2305 creates beneficial properties. By allowing the first and second internal connectors 2310, 2320 to freely pivot about a small angle (e.g., between >0° and about 60°, in particular, between about 20° and about 40°, in particular, about 30°), the internal connectors 2310, 2320 are allowed to easily self-align, so that when the second internal connector 2320 is inserted (in its longer exemplary embodiment), the first internal connector 2310 can pivot as desired while the second internal connector 2320 remains relatively stationary (referred to herein as passive alignment). The lengths of the internal connectors 2310, 2320 are discussed above.

[0196] The clamping rods 2210, 2220 are connected to the first and second internal connectors 2310, 2320, respectively. In this exemplary embodiment, the clamping rods 2310, 2320 have corresponding internal hollows 2218, 2228, which are in the form of cylindrical blind holes. Similarly, the first and second internal connectors 2310, 2320 have a first axis and a second axis, wherein the outer shape of each axis corresponds to the corresponding internal hollow 2218, 2228 to fit therein. In an exemplary embodiment, these shapes can have a circular cross-section and a rounded tip. However, the shapes of the two axes can be different, for example, one is a circular cross-section and the other is a polygonal cross-section. If the internal connectors 2310, 2320 are simply inserted into the internal hollows 2218, 2228, then the clamping rods 2210, 2220 are likely to slip off. In order to retain each of the clamp rods 2210, 2220 on the corresponding inner connector 2310, 2320, at least one of the inner connectors 2310, 2320 is provided with a connector lock not shown or both of the inner connectors 2310, 2320 are provided with connector locks (examples of which were described previously, such as locks 1614, 1624, 1818). More specifically, the lock allows the clip 2200 to be removably captured or secured to the delivery device 2300. A desirable exemplary shape of the entrance to each of the inner hollows 2218, 2228 is conical because it enables a user to insert the inner connector 2310, 2320 into the inner hollow 2218, 2228 and allow the shaft to subsequently enter therein even if the central axis of the inner connector 2310, 2320 is slightly misaligned with the central axis of the inner hollow 2218, 2228.

[0197] The clip 2200 is accessed and controlled from the interior of the clip 2200 rather than from the exterior of the clip 2200 by a delivery device (e.g., device 1600, 2300), which is sized to have a cross-sectional area equal to or less than the maximum cross-sectional diameter of the clip 2200. (Note that the internal hollow portion can be placed on the end of the cams 2302, 2304 and the internal connector can be located at the clamp rod in the opposite configuration.) This means that when the clip 2200 is in use, the width of the port is minimized to the maximum cross-sectional diameter of the clip 2200 rather than the diameter of the delivery device.

[0198] The upper biasing device and the lower biasing device 2230 form a biasing assembly that connects the first clamping bar 2210 to the second clamping bar 2220 to align the first and second clamping bars 2210, 2220 in a clamping bar plane, wherein the plane passes through the tissue contacting surfaces 2217, 2227. In this way, the upper biasing device and the lower biasing device 2230 allow the first and second clamping bars 2210, 2220 to move in the clamping bar plane, for example, to Figure 66 to Figure 69. As described above, the biasing assembly is configured to allow biasing movement of the first clamping bar 2110 and the second clamping bar 2210, 2220 in the clamping bar plane. The biasing movement of the first clamping bar 2110 in the clamping bar plane can be independent of the biasing movement of the second clamping bar 2120 in the clamping bar plane. Due to the position of the biasing assembly, the upper biasing device and the lower biasing device 2230 balance the forces so that the first clamping bar and the second clamping bar 2210, 2220 do not substantially experience rotation around the corresponding longitudinal axis when the first clamping bar 2210, 2220 moves in the clamping bar plane. The upper biasing device and the lower biasing device 2230 balance the forces so that the first clamping bar and the second clamping bar 2210, 2220 do not substantially experience torque when the first clamping bar 2210, 2220 moves in the clamping bar plane.

[0199] As explained above, the clips described herein, including the LAA clip 2200, are, for example, sized to fit into a laparoscopic port having an inner diameter. In this regard, the first and second clamp bars 2210, 2220 and the biasing assembly 2230 together have a maximum outer width that is no greater than the inner diameter of the port. An exemplary embodiment of a port into which the LAA clip 2200 can be inserted is a 10 mm thoracoscopic port (30 French). Thus, the LAA clip 2200 can fit within a port for thoracoscopic delivery to the LAA during a clip implantation procedure.

[0200] By the longitudinal length of the upper biasing means and the lower biasing means 2230, for example Fig.66 As shown, the first and second clamp rods 2210, 2220 have a maximum longitudinal length (parallel to the longitudinal axis of the clamp rods 2210, 2220) and the upper and lower biasing devices 2230 have a longitudinal length shorter than the maximum longitudinal length because this dimension ensures that when the compressed LAA tissue between the clamp rods 2210, 2220 is squeezed to extend beyond the biasing device 2230 (if this occurs), there is still material of the clamp rods 2210, 2220 available to contact the LAA tissue.

[0201] It should be noted that some exemplary embodiments described herein have upper and lower biasing devices 2030, 2130, 2230 on opposite sides of the clamping rod, each with a distal open end on the same side and a proximal biasing end 2211, 2221 on the same side. Fig.71 An alternative configuration is shown in which one of the biasing devices 2030, 2130, 2230 is rotated 180° to have two biasing ends that are opposite to each other. Fig.71In the exemplary configuration shown in the figure, the biasing means 2030, 2130, 2230 are still on the opposite side of the clamping rod. Therefore, this configuration does not allow the structure to be clamped (such as LAA) to enter from one end of the clamp; instead, the structure to be clamped enters the central clamping area 1970 from below or above the clamp.

[0202] In the foregoing exemplary embodiments of the biasing devices 2030, 2130, 2230, the upper and lower biasing devices are shown as being primarily constructed of round profile ropes. However, there are other designs and construction methods, each with its own advantages. For example, the rope may be a square or rectangular profile, such as Fig.75 and Fig.75A As shown, the biasing force of the biasing device 2330, 2430 can be carefully adjusted by independently changing the width and height of the rope profile. In addition, the edges of the polygonal profile rope can be rounded to various radii, allowing for even further adjustment of the biasing device 2030, 2130, 2230, 2330, 2430 while maintaining consideration of the interaction of the biasing device edge with delicate tissue.

[0203] Furthermore, in the foregoing embodiments of the biasing devices 2030, 2130, 2230, the upper and lower biasing devices are shown as separate components, each having two terminal ends. Alternatively, the biasing devices 2330, 2430 may be constructed from fewer or more separate components, resulting in fewer or more terminal ends. In an exemplary embodiment, the upper and lower biasing devices 2030, 2130, 2230 may be a single component. For example, the biasing devices 2330, 2430 may be in the form of a single continuous wire or flat component that is cut out of a flat stock and bent into shape, such as Fig.76 and Fig.76A In the configuration shown in , they are not in wire form but are two-dimensional shapes that are then cut and bent.

[0204] In an exemplary embodiment, the upper biasing device and the lower biasing device are connected at both ends to form a continuous loop without terminal ends. In another exemplary embodiment, the upper biasing device and the lower biasing device are connected at one location, resulting in two terminal ends. In yet another embodiment, the biasing device is manufactured by first cutting a flat continuous ring shape and then bending it into a final shape (mimicking the geometry of the biasing devices 2030, 2130, 2230 described above). In such a configuration, the four terminal ends may not terminate like two separate biasing devices, the structure can be one long biasing device wrapped around two terminal ends, or the biasing device can be a continuous component with no terminal ends.

[0205] An exemplary embodiment of the end effector shows a jaw control tether acting on the jaws in a direction vector parallel to the centerline of the clip (e.g., central longitudinal axis 2202). The jaw control tether is then bent approximately 45° to remain within the lumen of the U-clip and shaft. This configuration has a relatively long distance between the distal tip of the delivery cam and the proximal end of the U-clip and is therefore referred to as a long dead length. A longer dead length requires more space between the proximal end of the clip and the patient's tissue structure, which makes proper placement of the clip more difficult (especially in a tight chest).

[0206] A more favorable configuration minimizes the dead zone length, provides the surgeon with more space to manipulate the end effector and clip, and makes clip placement easier. Figures 77 to 80 The exemplary embodiment of the delivery device 2400 shown in FIG. 2 improves performance by reducing the dead zone length.

[0207] Fig.77 and Fig.78 Another exemplary embodiment of a delivery device 4200 shown in FIG. 4 is used to deliver a clip 1500, 2100, 2200 to the LAA 20. This exemplary embodiment has a pistol grip configuration. The delivery device 2400 has an end effector 2401, a handle 2409 having a lock / unlock control 2410 in the form of a button trigger, a jaw control 2420 in the form of a trigger, and a shaft 2430 having a shaft rotation knob 2432 and the end effector 2401. The lock / unlock control 2410 actuates a lock release cord 2416 in the form of a pull cord to unlock the lock 1614 of the locking clip 1500, 2100, 2200. When actuated, the lock / unlock control 2010 applies a proximally directed force (e.g., on the lock release cord) to release the lock 1614 on the clamp rod, thereby allowing the clip to leave the delivery device 2400 and be implanted. Only one lock 1614 is mentioned here, however, all locks described and contemplated herein are equally applicable to the delivery device 4200. To recapture the clip, the delivery device 2400 is moved to a recapture position and the first and second internal connectors 1610, 1620 are inserted into the first and second connector interfaces of the clamp rod, respectively. In the exemplary embodiment described herein, the lock controller (e.g., lock release rope 2416 and lock / unlock controller 2010) can automatically lock during recapture or the lock can be manually operated to lock the internal connectors 1610, 1620 within the connector interface of the clip. If it is desired that the end effector 2410 be rotated relative to the handle 2409, the surgeon rotates the shaft rotation knob 2432 in the desired direction.

[0208] Fig.79 and Fig.80The jaws and lock controller at the end effector 2401 are depicted in FIG. The facing half of the U-shaped clamp 2408 is Fig.80 1614, and the jaw control cord 2412 (which is connected to the cam 2424) moves the first and second delivery cams 2402, 2404 about their respective pivots 2406, 2407 when moved distally or proximally. The first and second internal connectors 1610, 1620 are pivotally connected to the first and second delivery cams 2402, 2404 about first and second distal pivots 2403, 2405, respectively.

[0209] In operation, the jaw control tether 2422 acts on the jaws 2402, 2404 on an axis that is not parallel to the centerline of the clip, eliminating the approximately 45° bend required to remain within the lumen of the U-clip 2401 and shaft 2430, and thereby shortening the deadband length. In addition, the removal of the approximately 45° bend facilitates a more linear actuation of the jaw control tether 2422 on the jaws, reducing friction and loads on the jaw control tether 2422, improving system performance and reducing wear on the delivery system. In summary, the longer deadband length on the distal end of the delivery system 1600 makes the clip more difficult to place in patients with tighter / narrower chests. Reducing the deadband length in the delivery system 2400 makes implantation easier by eliminating the 45° bend used in the jaw control tether.

[0210] In an exemplary configuration, a joystick can be used to change the angle from a straight forward position to an angled position. This configuration will allow the user to adjust the angle during surgery and will allow the shaft 2430 and end effector 2401 to be operated through a straight cannula.

[0211] As shown in the exemplary embodiments herein, the cross-section of the clamping bar is substantially rectangular. These are merely exemplary embodiments. The cross-section of the clamping bar may also be circular, oval, or polygonal. Therefore, the use of first, second, third, and fourth as descriptors of the four sides is merely exemplary and should not be considered limiting. In embodiments where the cross-section is circular or oval, the enumerated portions may be the first, second, third, and fourth quadrants, portions, or sides.

[0212] In this document, the term "cord" is used with respect to, for example, the first and second release cords 1616, 1618, the lock control cord 1816, and the jaw control cord 2022. This term is meant to be broad and is not limited to a specific material or cross-section. A cord refers to any longitudinally extending material that can include the structures and functions described herein. The term cord is not limited to a single cord; a cord can also be multiple cords. Therefore, a cord and multiple cords can be used interchangeably. A cord is also not limited to a specific type of material. To name a few, the material can be made of natural fibers, artificial or synthetic fibers, plastics, and / or metals. A cord is also not limited to a specific structure. To name a few, the material can be made of twisted strands, twisted strands with a central core, or a single strand of twisted wire or wire or rod. An exemplary embodiment described herein is a braided stainless steel cable. However, even if an example of a braided stainless steel cable is mentioned or used herein, the embodiments described herein are not limited to braided stainless steel cables.

[0213] In various instances herein, the holes are referred to as "blind" holes. Where so indicated, in exemplary alternative embodiments, some of the holes may be through holes.

[0214] It should be noted that various individual features of the inventive process and system may be described in only one exemplary embodiment herein. The specific selection of the description of a single exemplary embodiment herein should not be considered as a limitation that a specific feature is only applicable to the embodiment describing it. All features described herein may be equally applied to, attached to, or interchanged with any or all other exemplary embodiments described herein in any combination or grouping or arrangement. In particular, the use of a single reference numeral to illustrate, define, or describe a specific feature herein does not mean that the feature cannot be associated or equivalent with another feature in another figure or description. In addition, where two or more reference numerals are used in a figure or figure, this should not be interpreted as being limited to only those embodiments or features, and they are equally applicable to similar features or not using a reference numeral or omitting another reference numeral.

[0215] The above description and accompanying drawings illustrate the principles, exemplary embodiments, and operating modes of the systems, devices, and methods. However, the systems, devices, and methods should not be construed as being limited to the specific embodiments discussed above. Other variations of the embodiments discussed above will be appreciated by those skilled in the art, and the above embodiments should be considered illustrative rather than restrictive. Therefore, it should be understood that changes may be made to these embodiments by those skilled in the art without departing from the scope of the systems, devices, and methods defined by the following claims.

Claims

1. A device comprising: a handle portion defining a distal end; as well as an end effector, the end effector being coupled to the distal end of the handle portion, the end effector comprising: Clevis a first cam and a second cam, each of the first cam and the second cam being pivotally coupled to the clevis; A first clip connector, the first clip connector comprising a connector assembly pivotably coupled to the first cam, the connector assembly comprising: plunger; and a biasing device configured to bias the plunger distally away from the first cam; and a second clip connector pivotably coupled to the second cam, the first clip connector and the second clip connector being capable of articulating relative to each other; Wherein, the first clip connector and the second clip connector are configured to be removably received by a left atrial appendage (LAA) separation clip.

2. The device according to claim 1, characterized in that The connector assembly includes a housing including the plunger and the biasing device.

3. The device according to claim 2, characterized in that The housing includes a tubular outer shell.

4. The device according to claim 1, characterized in that The plunger defines a keyhole configured to receive a lock of the LAA distraction clip.

5. The device according to claim 1, characterized in that The second clip connector includes a rigid body.

6. The device according to claim 5, characterized in that The rigid body is a cylindrical pin.

7. The device according to claim 1, characterized in that The handle includes a lock / unlock control configured to cause the plunger to move proximally toward the first cam against the biasing device.

8. The device according to claim 7, characterized in that The device also includes at least one lock release cable coupling the lock / unlock control to the plunger.

9. The device according to claim 1, characterized in that The first cam includes a first distal pivot, the second cam includes a second distal pivot, wherein a proximal portion of the first clip connector is coupled to the first distal pivot, and wherein a proximal portion of the second clip connector is coupled to the second distal pivot.

10. The device according to claim 1, characterized in that The first clip connector includes a curved cord lock configured to be received in a lock aperture defined by the LAA distraction clip.

11. The device according to claim 10, characterized in that The bend cord lock includes a bend line including a bend portion extending radially outward from the first clip connector.

12. The device according to claim 11, characterized in that The flex wire comprises Nitinol.

13. The device according to claim 1, characterized in that At least one of the first clip connector or the second clip connector is biased to a substantially parallel orientation relative to the other of the first clip connector and the second clip connector.

14. The device according to claim 1, characterized in that The first clip connector defines a first length along a direction from the first cam to a distal end of the first clip connector, wherein the second clip connector defines a second length in a direction from the second cam to a distal end of the second clip connector, and wherein the second length is greater than the first length.

15. The device according to claim 14, characterized in that The device is configured such that movement of the handle allows passive alignment of the first clip connector with the second clip connector when the second clip connector is at least partially received in the LAA distraction clip.

16. An assembly comprising: A left atrial appendage (LAA) clip delivery and capture device, the device comprising: a handle portion defining a distal end; and an end effector, the end effector being coupled to the distal end of the handle portion, the end effector comprising: Clevis a first cam and a second cam, each of the first cam and the second cam being pivotally coupled to the clevis; A first clip connector, the first clip connector comprising a connector assembly pivotably coupled to the first cam, the connector assembly comprising: plunger; and a biasing device configured to bias the plunger distally away from the first cam; and a second clip connector pivotably coupled to the second cam, the first clip connector and the second clip connector being capable of articulating relative to each other; wherein the first clip connector and the second clip connector are configured to be removably received by a left atrial appendage (LAA) separation clip; and LAA separation clip, the LAA separation clip comprising: a first clamping bar formed with a first internal connector interface configured to receive the first clamp connector of the device; and A second clamping lever is formed with a second internal connector interface configured to receive the second clamp connector of the device.

17. The assembly of claim 16, wherein: The first internal connector interface includes an interface assembly including a lock extending proximally away from the first clamp bar and configured to mate with the first clamp connector.

18. The assembly of claim 17, wherein: The first clip connector defines a keyhole configured to receive the lock, and wherein the lock defines a curved locking surface configured to be received in the keyhole.

19. The assembly of claim 16, wherein: The first inner connector interface includes a locking aperture extending transverse to the first clamp bar, the locking aperture being configured to receive a portion of the first clamp connector.

20. The assembly of claim 19, wherein: The portion of the first clip connector configured to be received in the key aperture includes a bend line.

21. The assembly of claim 16, wherein: The second inner connector interface is a cylindrical hole, and wherein the second connector clip includes a cylindrical pin configured to be removably received in the cylindrical hole.

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