Devices and methods for left atrial appendage closure

Abstract

A tissue stabilization device and method for stabilizing and optionally closing a target tissue such as a left atrial appendage generally comprises an elongated body having a first lumen and a second lumen, a suction tip coupled to the elongated body, and an injection tip coupled to the elongated body proximal to the suction tip. The suction tip may define a suction aperture, and the suction aperture may be in fluid communication with the first lumen to apply suction to the target tissue. The injection tip may be in fluid communication with the second lumen to dispense contrast fluid.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Serial No. 62 / 648,827, filed on March 27, 2018, and entitled “DEVICES AND METHODS FOR LEFT ATRIAL APPENDAGE CLOSURE,” and U.S. Provisional Application Serial No. 62 / 746,453, filed on October 16, 2018, and entitled “DEVICES AND METHODS FOR LEFT ATRIAL APPENDAGE CLOSURE,” the contents of each of which are hereby incorporated by reference in their entirety. Technical Field

[0003] Described herein are devices and methods for stabilizing, visualizing, and / or ligating tissue, such as the left atrial appendage, using minimally invasive or endovascular approaches. Background Art

[0004] Atrial fibrillation is a common problem that afflicts millions of patients. Atrial fibrillation often results in the formation of a thrombus, or blood clot, in the auricle of the left atrium. This poses a problem because the clot can dislodge and cause embolism to distant organs, which can lead to adverse events, such as stroke. For this reason, most patients with atrial fibrillation are treated with one or more blood thinners to help prevent the formation of clots. However, blood thinners can carry their own health risks, especially in the elderly. These risks, such as bleeding, often require the user to make significant lifestyle changes.

[0005] Several methods have been developed to address the potential problem of thrombosis in the left atrial appendage (LAA). One such method involves suturing the left atrial appendage along the base or open neck where it connects to the atrioventricular chamber. In this way, blood entering the atrial appendage is cut off, thereby eliminating the risk of thrombus formation therein. Other methods have also been developed. These methods include stapling the base of the atrial appendage and filling the atrial appendage with an occupying space or occluding member. In view of the fragility of the atrial appendage and its tendency to rupture, stapling is not preferred, and occluding devices may not be effective in preventing all blood flow from entering the atrial appendage.

[0006] Most of these operations are usually performed by open heart surgery; however, some operations can also be performed using minimally invasive techniques. Many operations require multiple entry sites (e.g., a first entry site into the internal structure of the heart and a second entry site into the pericardial space) to advance the first device through the vascular system and into the left atrial appendage to assist in guiding and / or positioning the ligation element carried by the second device positioned in the pericardial space. Those operations that only require a single entry point require the use of a large surgical incision, a separate visualization tool, and at least one of a tool that is easy to tear the atrial appendage to grasp the fragile left atrial appendage and pierce the left atrial appendage. All of the foregoing may complicate the operation and / or make it more dangerous. For example, many known operations carry one or more of the following risks and / or complications: the risk of tearing the LAA, the complication of piercing the LAA, the complication of using a large surgical incision, the complication of advancing another tool through the body, the risk of perforation of the heart from the internal component, the risk of entrapment of the internal component, and the risk associated with transseptal access. In addition to increasing the risk of surgery, these risks and complications may also require increased recovery time, and / or may make the operation more expensive. Therefore, improved epicardial devices and methods for closing the left atrial appendage using minimally invasive techniques would be desirable. Summary of the invention

[0007] Devices, systems and methods for stabilizing, visualizing and / or closing a target tissue (e.g., a left atrial appendage) are described herein. Conventional fluoroscopy can be performed using an imaging device that injects contrast fluid into an area to be visualized. The imaging device can be formed separately from the tissue closure device. In this way, these imaging devices occupy space in the body cavity when the fluid is injected, and are usually removed for use in the tissue closure device after the contrast fluid is injected during the initial steps of the operation. If additional contrast fluid is needed later, the imaging device must be reinserted into the body cavity. Therefore, more time and steps are required to complete the operation using conventional imaging devices. The device described herein can form an integrated and compact device comprising a vacuum tube and a contrast fluid tube. The contrast fluid tube can be fixed relative to the vacuum tube and can allow contrast fluid to be injected during any step of the tissue closure operation, such as during a tissue aspiration step using a vacuum tube. This can reduce the complexity of the operation and the volume of contrast fluid injected into the body cavity. The contrast fluid tube can also be configured to be adjacent to the vacuum tube to allow uniform distribution of the contrast fluid.

[0008] Typically, the device described herein for closing target tissue may include an elongated body and a snare ring assembly, the elongated body including a first lumen passing through the elongated body. The snare ring assembly may include a snare and a suture loop releasably coupled to the snare, and may extend at least partially from the distal end of the elongated body. The device may further include a vacuum tube and an angiography tube. The vacuum tube may be configured to apply a vacuum to the target tissue by passing through a second lumen of the vacuum tube, and the angiography tube may be configured to inject a fluid by passing through a third lumen of the angiography tube. The vacuum tube and the angiography tube may be slidably positioned within the first lumen to extend through the snare ring assembly.

[0009] In some variations, the distal end of the third lumen can be proximal to the distal end of the second lumen. In some of these variations, the distal end of the third lumen can include an injection tip. In some of these variations, the injection tip can be coaxial and concentric with the vacuum tube. In some cases, the distal end of the third lumen can define a plurality of radial holes.

[0010] In some variations, the distal end of the second lumen within the distal end of the third lumen may define an annular aperture of the third lumen. In some variations, the angiography tube may be coaxial and concentric with the vacuum tube. In some variations, a distal tip may be coupled to the distal end of the second lumen and the distal end of the third lumen. In some of these variations, the distal tip may define an aspiration aperture and a plurality of injection apertures. In some of these variations, the aspiration aperture may be coupled to the second lumen, and the plurality of injection apertures may be coupled to the third lumen.

[0011] In some variations, one or more of the elongated body and the vacuum tube may include one or more electrodes configured to receive electrocardiogram signals. In some variations, the closure device may be configured to generate negative pressure through the vacuum tube. In some variations, a vacuum pump may be operably connected to the second lumen and may be configured to provide suction at the distal end of the second lumen. In some variations, the distal end of the second lumen may include a suction tip. In some variations, the device may include a handle coupled to the elongated body, the vacuum tube, and the angiography tube. The handle may include one or more of a snare control, a vacuum tube control, an angiography control, and a vacuum control. In some variations, the device may further include a sheath, and the sheath may include a fourth lumen. In some cases, the elongated body may be slidably positioned within the fourth lumen.

[0012] In some variations, the distal end of the elongated body may include a suture loop cutting assembly configured to separate the suture loop from the elongated body. In some variations, the distal end of the vacuum tube may include a balloon. The balloon may define a fourth lumen operatively coupled to the second lumen. In some variations, a sliding fastener may couple the elongated body to the vacuum tube and the angiography tube.

[0013] In some variations, a device for stabilizing a target tissue is provided. The tissue stabilization device may include an elongated body, an aspiration tip, and an injection tip, the elongated body including a first lumen and a second lumen. The aspiration tip may be coupled to the elongated body and may define a suction aperture, the aspiration aperture being in fluid communication with the first lumen to apply suction to the target tissue. The injection tip may be coupled to the elongated body proximal to the aspiration tip and may be in fluid communication with the second lumen to dispense a contrast fluid.

[0014] In some variations, the injection tip can be fixedly coupled to the aspiration tip. In other variations, the injection tip and the aspiration tip can be integrally formed. In some embodiments, the distal end of the first lumen can extend beyond the distal end of the second lumen. In some variations, the injection tip can be coaxial and concentric with the aspiration tip.

[0015] In some embodiments, the injection tip may include a plurality of injection holes. In some of these embodiments, the injection tip may include a proximal circumference and a distal circumference. In some cases, the injection holes may define approximately 40% of the distal circumference. In addition, in some variations, the injection tip may include a cylindrical proximal portion, a conical middle portion, and a cylindrical distal portion, and the plurality of injection holes may be located in the cylindrical distal portion. In some of these variations, the plurality of injection holes may open the cylindrical distal portion by approximately 40%. In some variations, each of the plurality of injection holes may have the same area. In some of these variations, the area may be at least approximately 0.0024 in 2 In some cases, the injection tip can include four injection holes.

[0016] In some variations, the aspiration tip may include a conical proximal portion and a cylindrical distal portion. In some of these variations, the injection tip may include a cylindrical distal portion, and the diameter of the cylindrical distal portion of the injection tip may be approximately equal to the diameter of the cylindrical distal portion of the aspiration tip.

[0017] In some variations, the first lumen of the elongated body can have a circular cross-sectional shape, and the second lumen can have a crescent cross-sectional shape. In some variations, the device can be configured to generate negative pressure through the first lumen. In some variations, a vacuum pump can be operably connected to the first lumen and can be configured to provide suction at the distal end of the first lumen. In some variations, a contrast fluid source can be fluidly coupled to the second lumen. In some embodiments, the suction tip can include one or more electrodes configured to receive electrocardiogram signals.

[0018] In some variations, the tissue stabilization device may include a guide wire that can be positioned in the first lumen. In some of these variations, the guide wire can be configured to provide kink resistance to the elongated body. In some cases, the guide wire can include a tapered central portion. In some variations, the device can further include a coil positioned around a portion of the guide wire. Additionally or alternatively, the device can include a radiopaque marker ring. In some variations, the distal end of the guide wire can terminate in the radiopaque marker ring.

[0019] In some variations, a handle can be coupled to the proximal end of the elongated body. In some cases, the handle can include a contrast fluid control and a vacuum control. In some of these variations, the vacuum pump can be operatively coupled to the vacuum control, and the contrast fluid source can be fluidly coupled to the contrast fluid control. In some of these variations, the contrast fluid source can include an injector. In some of these variations, the handle can include a first Y-shaped connector and a second Y-shaped connector.

[0020] Methods for stabilizing and / or closing target tissue are also described herein. Typically, the device used in the method may include an elongated body and a snare loop assembly, the elongated body including a first lumen passing through the elongated body. The snare loop assembly may include a snare and a suture loop releasably coupled to the snare. The device may further include a vacuum tube slidably positioned within the first lumen. The vacuum tube may include a second lumen passing through the vacuum tube. An imaging device may be disposed within the distal end of the second lumen.

[0021] In some variations of the method, the method may include advancing the device toward a target tissue. The device may include an elongated body, a snare loop assembly, a vacuum tube, and a contrast tube, the elongated body including a first lumen passing through the elongated body. The snare loop assembly may include a snare and a suture loop releasably coupled to the snare. The vacuum tube and the contrast tube may be slidably positioned within the first lumen. The vacuum tube may include a second lumen passing through the vacuum tube, and the contrast tube may include a third lumen passing through the contrast tube. The distal end of the contrast tube may be proximal to the distal end of the vacuum tube. The vacuum tube may be advanced away from the elongated body and through the snare loop assembly. The method may further include applying a vacuum to the target tissue through the second lumen, injecting a fluid toward the target tissue through the third lumen, advancing the snare loop assembly around the target tissue, and tightening the suture loop around the target tissue.

[0022] In some variations, the method may further include visualizing the target tissue using the injected fluid, confirming application of the vacuum to the target tissue using the injected fluid, and / or receiving an electrocardiogram signal using one or more electrodes disposed on the device. In some of these variations, an electrocardiogram signal may be used to confirm application of the vacuum to the target tissue.

[0023] In some embodiments, the method may further include closing the snare loop assembly around the target tissue and releasing the suture loop from the snare loop assembly. In some variations, applying the vacuum to the target tissue can draw the target tissue into the suction tip of the second lumen. In some variations, the applying the vacuum can keep the vacuum tube against the target tissue. In some variations, the method may further include advancing the elongated body and the vacuum tube through a sheath. In some variations, the elongated body and the vacuum tube can be advanced through an entry site into the pericardial space. In some of these variations, the elongated body and the vacuum tube can be advanced percutaneously.

[0024] In some variations, advancing the snare ring assembly around the target tissue may include advancing the elongated body toward the distal end of the vacuum tube. In some variations, the method may further include retracting the vacuum tube and the angiography tube into the elongated body and / or withdrawing the device from the body. In some variations, the method may include advancing a sheath into the pericardial cavity and insufflating the pericardial cavity using the sheath. In some embodiments, the method may further include extending the distal end of the vacuum tube after advancing the vacuum tube away from the elongated body. In some variations, the target tissue may include one or more of the left atrial appendage and the myocardium.

[0025] In some variations of the method of closing a target tissue, a tissue stabilization device can be advanced toward the target tissue. The tissue stabilization device can include an elongated body, a suction tip, and an injection tip, the elongated body including a first lumen and a second lumen. The suction tip can be fluidically coupled to the first lumen, and the injection tip can be fluidically coupled to the second lumen. A vacuum can be applied to the target tissue through the first lumen, and a fluid can be injected toward the target tissue through the second lumen. The injected fluid can be used to visualize the target tissue. A closure device can be advanced toward the target tissue along the tissue stabilization device, and the target tissue can be closed with the tissue closure device.

[0026] In some variations of the methods described herein, the injection tip can be fixed to the aspiration tip. In some of these variations, the closure device can include an elongated body including a first lumen passing through the elongated body, a snare loop, and a suture loop releasably coupled to the snare loop. In some of these variations, closing the target tissue can include advancing the snare loop and the suture loop around the target tissue and tightening the suture loop around the target tissue.

[0027] In some variations, the tissue stabilization device can be positioned within the lumen of the elongated body of the closure device during advancement of the closure device toward the target tissue. In some cases, the fluid can be injected before applying the vacuum, and the method can further include using the injected fluid to identify the target tissue before applying the vacuum to the target tissue. In some variations, the fluid can be injected after applying the vacuum, and the method can further include using the injected fluid to confirm the application of the vacuum to the target tissue. In some variations, the fluid can be injected toward the target tissue through the second lumen before applying the vacuum. In some of these variations, the method can further include using the injected fluid to identify the target tissue before applying the vacuum to the target tissue.

[0028] In some variations, after advancing the closure device toward the target tissue, a fluid may be injected through the second lumen toward the target tissue. In some variations, the target tissue may be a left atrial appendage. In some of these variations, the pericardial space may be flushed with saline. In some cases, a pericardial drain may be placed, and the saline in the pericardial space may be drained using the pericardial drain.

[0029] In some variations of the methods for closing target tissue described herein, a tissue stabilization device including an elongated body, a suction tip, and an injection tip can be advanced toward the target tissue. The elongated body may include a first lumen and a second lumen. The suction tip may be coupled to the elongated body, and the injection tip may be coupled to the elongated body proximal to the suction tip. Contrast fluid may be injected toward the target tissue through the injection tip for the first time, and vacuum may be applied to the target tissue through the suction tip. Contrast fluid may be injected toward the target tissue through the injection tip for the second time. The closure device may be advanced toward the target tissue along the tissue stabilization device. The closure device may include an elongated body including a first lumen passing through the elongated body, a snare ring, and a suture ring releasably coupled to the snare ring. The snare ring and the suture ring may be advanced around the target tissue, and the suture ring may be tightened around the target tissue.

[0030] In some variations, the method may include identifying the target tissue with the contrast fluid from the first injection, and confirming the application of vacuum to the target tissue with the contrast fluid from the second injection. The method may further include injecting contrast fluid toward the target tissue through the injection tip for a third time, and the third injection may occur after advancing the snare loop and the suture loop around the target tissue. In some of these variations, the contrast fluid from the third injection may be used to confirm the capture of the snare loop with the target tissue. In some of these variations, the method may further include injecting contrast fluid toward the target tissue through the injection tip for a fourth time, and the fourth injection may occur after tightening the suture loop around the target tissue. In some of these variations, the method may further include confirming that the target tissue is closed with the contrast fluid from the fourth injection. In some cases, the method may further include releasing the vacuum from the target tissue before tightening the suture loop. In addition, in some of these variations, the target tissue may be a left atrial appendage. In some of these variations, the pericardial space may be flushed with saline. In some variations, a pericardial drain may be placed and the saline in the pericardial space is drained using the pericardial drain. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Cross-sectional illustrations of the heart showing various anatomical structures are provided.

[0032] Figure 2 is a perspective view of an illustrative variation of a closure device that may be used to close target tissue.

[0033] Figure 3A is a perspective view of the distal end of an illustrative variation of a closure device having a snare loop assembly. Figure 3B-3D yes Figure 3A A side view of the closure device is shown.

[0034] Figures 4A-4D is a perspective view of an illustrative variation of a closure device. Figure 4E-4H yes Figure 4D A cross-sectional view of an illustrative closure device depicted in FIG. Fig. 4I is a cross-sectional side view of a variation of a closure device.

[0035] Figure 5A-5B is a side view of an illustrative variation of a closure device.

[0036] Figure 6 is a side view of an illustrative variation of a vacuum tube.

[0037] Figures 7A-7F is a perspective view of an illustrative variation of a portion of a vacuum tube. Fig. 7A , 7C and 7E show an illustrative suction tip of the vacuum tube. Figure 7B , 7D and 7F depicts Fig. 7A , 7C and the suction tip coupled to tissue in 7E.

[0038] Figure 8 is a side view of an illustrative variation of a vacuum tube coupled to heart tissue.

[0039] Fig.9A is a schematic side view of an illustrative variation of a vacuum tube and heart tissue. Fig. 9B yes Fig.9A A perspective view of a vacuum tube coupled to a left atrial appendage as depicted in FIG.

[0040] Fig. 10A is a schematic side view of an illustrative variation of a vacuum tube and heart tissue. Fig. 10B yes Fig. 10A A perspective view of a vacuum tube coupled to a left atrial appendage as depicted in FIG.

[0041] Fig.11A is a side view of an illustrative variant of an echo vacuum tube. Figures 11B-11C Illustrative variants of echogenic surfaces are depicted.

[0042] Figures 12A-12D are images taken from the distal end of a variant of the closure device.

[0043] Fig.13A is a detailed side view of an illustrative variation of a closure device. Figures 13B-13C is a cross-sectional view of the illustrative closure device depicted in 13A.

[0044] Figures 14A-14F is a schematic diagram of an illustrative variation of a vacuum tube. Fig.14A is a cross-sectional side view of an illustrative variation of a vacuum tube. Fig. 14B yes Fig.14A Front view of the vacuum tube depicted in . Fig. 14C is a perspective view of another variation of the vacuum tube. Figures 14D-14F Depicted separately Fig. 14C A plan view, a cross-sectional side view, and a front view of the vacuum tube depicted in FIG.

[0045] Fig.15A is a perspective view of an illustrative variation of a handle for a closure device. Figures 15B-15C yes Fig.15A A cross-sectional perspective view of the handle depicted in FIG.

[0046] Fig.16 is a side view of an illustrative variation of a handle for a closure device.

[0047] Fig.17 is a flow chart describing variations of a method of closing tissue.

[0048] Figures 18A-18C Illustrative variations of closure devices and corresponding images generated by the closure devices are depicted.

[0049] Fig.19 is a perspective view of an illustrative variation of a vacuum tube.

[0050] Fig. 20 is a perspective view of an illustrative variation of an aspiration tip of a vacuum tube.

[0051] Fig.21A is a perspective view of an illustrative variation of a closure device. Fig. 21B yes Fig.21A A perspective view of the distal portion of the closure device depicted in FIG.

[0052] Fig. 22 is a perspective view of an illustrative variation of the sheath.

[0053] Figures 23A-23D is a perspective view of an illustrative variation of a vacuum device, a closure device, and heart tissue.

[0054] Figures 24A-24D is a side view of an illustrative variation of a vacuum tube.

[0055] Figures 25A-25B is a schematic diagram of an illustrative variation of a vacuum tube. Fig.25A is a cross-sectional side view of a vacuum tube. Fig.25B yes Fig.25A A front perspective view of the vacuum tube depicted in FIG.

[0056] Figures 26A-26B is a perspective view of an illustrative variation of a closure device.

[0057] Figures 27A-27F is a perspective view of an illustrative variation of a closure device for use in a tissue closure procedure.

[0058] Figures 28A-28B is a schematic diagram of an illustrative variation of a closure device. Fig.28A is a perspective view of the distal tip, and Fig.28B yes Fig.28A Detailed side view of the distal tip depicted in .

[0059] Figures 29A-29E is a schematic diagram of an illustrative variation of the sheath. Figures 29A-29B is a side view of the sheath. Fig.29C yes Fig.29B A front perspective view of the sheath depicted in FIG. Figures 29D-29E is a detailed side view of the distal end of another illustrative variation of a sheath.

[0060] Figures 30A-30C is a schematic side view of an illustrative variation of a sheath.

[0061] Figures 31A-31C is a schematic diagram of an illustrative variation of a sheath positioned within a patient's anatomy. Fig.31A is a cross-sectional side view of the patient's anatomy. Figures 31B-31C is a side view of the sheath in the patient's anatomy.

[0062] Figures 32A-32B are bottom perspective and side views, respectively, of an illustrative variation of a closure device.

[0063] Figures 33A-33C is a perspective view of an illustrative variation of a vacuum tube. Fig.33D is a front view of a variation of a vacuum tube.

[0064] Figures 34A-34C are perspective views of illustrative variations of vacuum tubes in different configurations.

[0065] Figures 35A-35B are side and perspective views of illustrative variations of the sheath. Fig.35C and 35H is a front perspective view of an illustrative variation of a dilator. Fig.35D is placed in Figures 35A-35B The sheath depicted in Fig.35C A front perspective view of the dilator depicted in FIG. Fig.35E is placed in Figures 35A-35B The sheath depicted in Fig.35C A posterior perspective view of the dilator depicted in FIG. Fig.35Fis a front perspective view of an illustrative variation of a sheath and endoscope. Figure 35G yes Fig.35F A front perspective view of the elongated body of the sheath depicted in FIG. Fig.35I is placed in Fig.35F The sheath depicted in Fig.35H A front perspective view of the dilator depicted in FIG. Fig.35J yes Fig.35I A front perspective view of the elongated body and dilator depicted in FIG.

[0066] Figures 36A-36B is a side view of an illustrative variation of the sheath.

[0067] Figures 37A-37B is a side view of an illustrative variation of a sheath in a patient's anatomy.

[0068] Fig.38A is a perspective view of an illustrative variation of the proximal end of the sheath, and Figures 38B-38C is a cross-sectional side view of an illustrative variation of the proximal end of the sheath.

[0069] Figures 39A-39B is a perspective view of an illustrative variation of a proximal portion of a sheath.

[0070] Fig.40A is a side view of an illustrative variation of a closure device including a vacuum tube and a contrast tube, and Fig.40B is a cross-sectional side view of an illustrative variation of the closure device including a vacuum tube and a contrast tube.

[0071] Fig.41A is a cross-sectional side view of an illustrative variant of a vacuum tube and a contrast tube, and Fig.41B is a cross-sectional front view of an illustrative variation of the vacuum tube and contrast tube.

[0072] Figures 42A-42B is a perspective view of an illustrative variant of a vacuum tube and a contrast tube, and Fig.42C is a cross-sectional side view of an illustrative variation of the vacuum tube and contrast tube.

[0073] Figures 43A-43F is an illustrative graph of electrocardiogram signals received from a closure device and surface electrodes, with the y-axis representing voltage in millivolts and the x-axis representing time in milliseconds.

[0074] Fig.44A is a side view of an illustrative variation of a closure device including a vacuum tube and a contrast tube, and Fig.44B is a cross-sectional side view of an illustrative variation of the closure device including a vacuum tube and a contrast tube.

[0075] Fig.45Ais a side view of an illustrative vacuum tube and contrast tube, Fig.45B is a cross-sectional side view of the illustrative vacuum tube and contrast tube, and Fig.45C is a cross-sectional front view of the illustrative vacuum tube and contrast tube.

[0076] Fig.46A is a side view of an illustrative variation of a closure device, and Fig.46B is a cross-sectional side view of an illustrative variation of the closure device. Fig.46C yes Fig.46A and 46B An illustrative variation of the manifold of the closure device depicted in . Fig.46D yes Fig.46A and 46B A cross-sectional front view of the elongated body of the closure device depicted in FIG.

[0077] Fig.47A , 47B 47A and 47B are front perspective, side, and front views, respectively, of an illustrative variation of an injection tip.

[0078] Fig.48A , 48B 48A and 48B are front perspective, rear perspective, and side views, respectively, of an illustrative variation of the aspiration tip.

[0079] Fig.49 is an exploded view of a distal portion of an illustrative variation of a closure device.

[0080] Fig.50A is a side view of a distal end of an illustrative variation of a closure device, and Fig.50B is a cross-sectional side view of the distal end of an illustrative variation of the closure device.

[0081] Fig.51 is a flow chart depicting an illustrative variation of a method of closing tissue.

[0082] Figures 52A-52C Illustrative variations of sheaths, closure devices, and tissue stabilization devices are depicted at various points in variations of methods of closing tissue. DETAILED DESCRIPTION

[0083] Devices, systems, and methods are described herein for closing tissue, such as the left atrial appendage.Where the heart is the relevant anatomical structure, it may be helpful to briefly identify and describe the relevant cardiac anatomical structure. Figure 1is a cross-sectional view of a heart (100). The left atrium (102) and the left ventricle (104) are shown. Between the left atrium (102) and the left ventricle (104) is the mitral valve (also called the bicuspid valve), which is defined by a pair of mitral valve leaflets (106). The leaflets are connected to chordae tendineae (108), which are connected to papillary muscles (110). The papillary muscles are connected to the ventricular wall (112). The left atrial appendage (114) is shown adjacent to and formed by the wall of the left atrium (102).

[0084] As can be seen, the left atrial appendage (114) is located within the boundaries of the pericardium (116) and in close proximity to the ventricular wall (112). The left atrial appendage typically has a tubular shape that approximates a cone, with a slight narrowing or neck in the plane of its hole connecting to the left atrium (102). In patients with atrial fibrillation, the left atrial appendage (114) is the most common site for thrombus formation, which may dislodge in time and cause a devastating stroke. Because stroke is a major complication of atrial fibrillation, the left atrial appendage is often excluded from the left atrium of patients undergoing surgery to treat atrial fibrillation, and is often removed or excluded during other surgical procedures, such as mitral valve surgery, to reduce the risk of future stroke. The devices and systems described herein help ensure proper closure of the left atrial appendage at the neck or base of the left atrial appendage along the anatomical opening plane. In this way, the exclusion of the entire left atrial appendage from the systemic circulation can be facilitated.

[0085] I. Device

[0086] Closure devices and methods for using closure devices to close target tissue are described herein. Typically, the closure device may include an elongated body and a snare ring assembly extending at least partially from its distal end. The snare ring assembly may form a ring and may include a snare and a suture ring releasably coupled to the snare. The closure device described herein may further include a first lumen, a vacuum tube, and a contrast fluid tube, each of which may be slidably positioned within the first lumen. The vacuum tube may include a second lumen passing through the vacuum tube, and in some variations, the second lumen may accommodate and / or be coupled to an imaging device. The contrast fluid tube may include a third lumen, in which a fluid may be injected through it. In some variations, the distal end of the third lumen may be close to the distal end of the second lumen.

[0087] In some cases, the vacuum tube and contrast tube can assist in the visualization, confirmation and stabilization of the target tissue. For example, in some variants, the vacuum tube and contrast tube can be used to: 1) view and identify the internal structures of the patient's body when the closure device is advanced to the target tissue and positioned relative to the target tissue, and / or 2) apply vacuum to the target tissue to draw the target tissue toward the closure device and / or maintain contact with the target tissue to facilitate the snare ring assembly to advance around the target tissue, and / or 3) inject contrast fluid to visualize the tissue and / or confirm the application of vacuum to the target tissue, and / or 4) receive an electrical signal for confirming the vacuum suction of the target tissue to the closure device. This function can be provided by epicardial access without endocardial access. For example, in a variant in which the vacuum tube can assist in visualization, the vacuum tube can include an imaging device that is held together with the vacuum tube and / or can be operably connected to the imaging device, so that the image captured by the imaging device through the vacuum tube can be used to assist in advancing and / or positioning the vacuum tube relative to the target tissue (e.g., a camera positioned in or advanced through the lumen of the vacuum tube). The imaging device can further image the tissue drawn into the vacuum tube to confirm capture of the desired target tissue.

[0088] In some variants, a set of electrodes placed on one or more of the inner and outer surfaces of the closure device, vacuum tube, and / or imaging device can be used to identify and / or map tissue. The electrical signal received by the electrode in contact with the tissue can be used to identify the position of the tissue and / or device. The electrode data can be further combined with other visualization data (e.g., from a mapping system) to generate a visual map of the heart. In some variants, other imaging methods can be used, such as fluoroscopy, fluorescence (near-infrared fluorescence, laser-induced fluorescence). In the case where the vacuum tube can assist in stabilization, the vacuum tube can provide suction to temporarily keep a portion of the target tissue against the suction tip of the vacuum tube and / or closure device. The suction tip of the vacuum tube can be anti-damage to reduce the risk of damaging the tissue. The suction provided by the vacuum tube can keep the target tissue in a proper position relative to the closure device while the snare ring assembly advances or unfolds around the left atrial appendage to temporarily or permanently close and / or ligate the target tissue. Visualization and / or stabilization of the target tissue provided by the vacuum tube can assist in effectively and efficiently advancing the closure device to the target tissue and positioning and holding the target tissue so that the snare loop assembly can be deployed and the suture loop can be placed at the desired location for tissue closure.

[0089] As described above, the closure device described herein can be used to close and / or ligate target tissues such as the left atrial appendage. When used in a left atrial appendage closure surgery, the closure device can be, for example, percutaneously advanced toward the pericardial space. As described above, in some variations, an imaging device placed in the lumen of the vacuum tube can be used to assist in manipulating the closure device to the left atrial appendage. Once the closure device reaches the left atrial appendage, the imaging device can be used to visualize the left atrial appendage so that the vacuum tube can be advanced away from the elongated body and through the ring of the snare ring assembly toward the desired visualization position on the left atrial appendage. The lumen of the vacuum tube can be used to apply force (e.g., suction) to the left atrial appendage to pull the atrial appendage toward the distal end of the vacuum tube lumen, thereby positioning the closure device to advance the snare ring assembly around the left atrial appendage. Once the vacuum tube and closure device are positioned as desired relative to the atrial appendage, the snare ring assembly can be advanced distally toward and around the target tissue along the vacuum tube that can be used as a guide. The snare ring assembly can then be closed around the target tissue, and the suture loop can be released from the snare ring assembly to temporarily or permanently close or ligate the target tissue. The closure device described herein can be suitable for advancing to the left atrial appendage using a minimally invasive approach, such as through a small incision above, below, or through the chest, through an incision in the costal cartilage or xiphoid process, etc. Because the closure device described herein provides visualization and stabilization of the left atrial appendage during closure, only a single entry point (e.g., an incision or port) to the left atrial appendage may be required. In other words, the closure device described herein can be used to close the left atrial appendage from the pericardial space without having to access the internal structures of the heart through the vascular system or otherwise. The devices and systems described herein may include devices and systems described in U.S. application serial number 15 / 713,376 filed on September 22, 2017, the contents of which are incorporated by reference in their entirety.

[0090] Figure 2 An illustrative variation of a closure device (200) that can be used to close a left atrial appendage is depicted. Figure 2 As shown, the closure device (200) can include a snare loop assembly (202), an elongated body (204), and a handle (206). The handle (206) can be coupled to the proximal end of the elongated body (204) and can be used, among other things, to control and actuate the snare loop assembly (202), which can extend at least partially from the distal end of the elongated body (204). As will be discussed in more detail below, controls (e.g., sliders, buttons, knobs, switches, etc.) on the handle (206) can move the snare loop assembly (202) between a closed configuration and an open, deployed configuration.

[0091] When in the open configuration, the snare loop assembly (202) and the elongated body (204) can form a continuous loop (208) (e.g., such that the snare loop assembly (202) and the elongated body (204) can completely surround tissue placed in the loop (208)). When moving from the open configuration to the closed configuration, the size of the loop (208) can decrease as some or all of the snare loop assembly (202) is withdrawn into the elongated body (204). In the closed configuration, the loop (208) can be completely disposed within the elongated body (204), or a majority of the loop (208) can be disposed within the elongated body (204), with a small portion of the loop (208) remaining outside of the elongated body (204). It should be noted that for clarity, Figure 2 The vacuum tube is not shown in FIG. 1 and will be described in more detail below.

[0092] Snare Ring Assembly

[0093] The snare loop assembly can be used to temporarily close and / or restrict one or more target tissues. Typically, the snare loop assembly includes a closure element (e.g., a snare) and a suture loop releasably attached to the closure element. In some variations, the snare loop assembly may include a retaining member that at least temporarily couples the closure element and the suture loop. The snare can be at least partially modifiable to move the snare loop assembly between an open, closed, and retracted configuration. Typically, a portion of the snare can be housed in the elongated body, and another portion of the snare can extend to the exterior of the distal end of the elongated body to at least partially define the loop and hole of the snare loop assembly.

[0094] The snare loop assembly can be closed around tissue to temporarily or permanently close, ligate or otherwise tighten tissue, and the suture loop can be tightened and released from the snare to hold the tissue or otherwise maintain the tissue in a closed configuration. Before or after the suture loop is tightened, the snare loop assembly can be retracted into the elongated body to facilitate removal of the closure device from the restricted body space. Once the suture loop is tightened around the left atrial appendage, the tissue aspirated from the suction tip of the vacuum tube can be released, which can allow visual confirmation of tissue closure by an imaging device.

[0095] Figure 3AA distal section of an illustrative variation of a closure device (300) is shown, the closure device comprising a snare loop assembly (302) and an elongated body (304) comprising a tip (306). As shown, the snare loop assembly (302) can include a snare (308), a suture loop (310), and a retaining member (312), and can be positioned relative to the elongated body (304) such that at least a portion of the snare loop assembly (302) extends from the distal end of the elongated body (304) (e.g., through the tip (306)). Figure 3A The snare loop assembly (302) is shown in an open configuration, and the portion of the snare loop assembly (302) extending out of the elongated body (304) can form a loop (314) having a hole (316) therethrough. The loop (314) and the corresponding hole (316) can be defined by one or more components (e.g., a snare) of the snare loop assembly (302) and the distal end of the elongated body (304), and can be adapted to surround tissue such as a left atrial appendage. Typically, the snare (308) can be used to open and close the snare loop assembly (302). In some cases, the retaining member (312) can be configured to release the suture loop (310) from the snare loop assembly (302) when sufficient force is applied to the suture loop (310).

[0096] As described above, the snare (308) can be movable to change the configuration (e.g., shape, diameter, circumference) of the snare ring assembly (302). In some variations, one end of the snare can be fixed relative to one or more portions of the closure device, while the other end can be coupled to a movable portion of the handle so that it can advance or retract through the elongated body. Movement of the free end of the snare can change the amount of the snare ring assembly disposed outside the elongated body and surrounding the vacuum tube (not shown), and thus can change the size (e.g., diameter, circumference, area) of the ring and the hole defined thereby. Specifically, advancement of the snare through the elongated body can increase the size of the ring and hole of the snare ring assembly, while retraction of the snare through the elongated body can reduce the size of the ring and hole of the snare ring assembly. The free end of the snare can be directly attached to one or more portions of the handle (e.g., a slider, button, knob, switch, etc.), or can be coupled to the handle by a rigid structure, such as a hypotube, rod, etc. The rigid structure can be coupled to and moved by a handle that can advance or retract the free end of the snare and thereby open and close the snare loop assembly. Although described as being coupled to a portion of the handle, the free end of the snare does not have to be manipulated and can be manipulated in any suitable manner. The fixed end of the snare can be coupled to any suitable portion of the closure device, such as any portion of the elongated body (304) including the tip (306) or the handle. In some variations, the fixed end of the snare can be releasable and in some cases retractable into the lumen of the elongated body, which can assist in releasing the target tissue from the hole in the snare loop assembly after the suture loop is deployed. Utilizing a releasable or retractable snare can also assist in withdrawing the closure device from the body.

[0097] The closing element (e.g., snare) can be made of any suitable material or combination of materials. For example, in some variations, the snare can be made of a shape-memory material, such as a shape memory alloy (e.g., nickel-titanium alloy, etc.), or can be made of stainless steel, polyester, nylon, polyethylene, polypropylene, or a combination thereof. In variations where the snare is made of a shape-memory material, the snare can be configured to present a specific shape or configuration when the snare ring assembly is placed in an open configuration, but can still be at least partially withdrawn into the elongated body to place the snare ring assembly in a closed configuration. For example, when the snare ring assembly is placed in an open configuration, the snare can form a generally circular, teardrop-shaped, elliptical or ellipsoidal or triangular ring. In some cases, when the snare ring is in a closed configuration, the snare ring is at least partially withdrawn into the elongated body and tightened around the circumference of the vacuum tube extending through the snare ring. In some variations, the snare can be radiopaque and / or include radiopaque materials and / or markings.

[0098] Additionally, in some variations, the snare loop assembly can be angled relative to the elongated body and / or the vacuum tube. Angling the snare relative to the elongated body and / or the vacuum tube can help the snare advance over the vacuum tube and capture tissue because the angulation can better position the snare relative to the tissue. Figure 3B As shown, the plane of the snare loop assembly (302) is generally perpendicular to the distal end of the elongated body (304), however, the plane of the snare loop assembly (302) may vary over a wide range of angles (α), such as Figure 3B-3D In some variations, the angle (α) may be preset, while in other variations, the angle (α) may be adjustable within a predetermined range. For example, the angle (α) formed between the plane of the snare loop assembly (302) and the distal end of the elongated body (304) may be between about 5 degrees and about 85 degrees ( Figure 3C ), can be between about 5 degrees and about 45 degrees, can be about 90 degrees ( Figure 3B ), or may be between about 95 degrees and less than 180 degrees ( Figure 3D ). It should be noted that the angle (α) may be close to 180 degrees, so long as a vacuum tube (not shown) is configured to extend through the aperture (316) of the snare ring assembly (302).

[0099] Suture loop

[0100] The snare loop assembly described herein may also include a suture loop for maintaining tissue in a closed manner. Typically, the suture loop may be releasably attached to the snare, for example, by a retaining member, as will be described in more detail below. In addition, the suture loop may include a suture knot, but is not required. This suture knot may be any suitable knot, including but not limited to a sliding knot (e.g., a one-way sliding knot) or a Meltzer knot. In some variations, at least a portion of the knot may be retained within the tip of the elongated body. In other variations, the suture knot at least partially extends from the tip of the elongated body, or may be positioned outside the tip, and may temporarily maintain a fixed relationship with the elongated body. When the suture loop includes a suture knot, the suture loop may include a loop portion, a suture knot, and a tail extending from the suture knot. The suture tail may be pulled through the suture knot to reduce the diameter of the loop portion.

[0101] In the variant where the suture loop includes a sliding knot, the suture can be advanced or withdrawn by the sliding knot to change the size of the suture loop. In the case where the suture knot is held in the tip of the elongated body or held against the tip of the elongated body, the suture knot can change the size of the suture loop without moving. This can help prevent the closure device from damaging the tissue. In some variants, the suture loop may include a one-way locking structure. In these variants, the one-way locking structure may be any structure that can advance in one direction along the suture but resists movement in a second direction. In these variants, the locking structure may be advanced on a portion of the suture loop to help lock the suture knot in place. The locking structure may be advanced by one of the closure devices described herein, or the locking structure may be advanced by a separate device after the suture loop has been released from the closure device.

[0102] The suture loop can be made of any suitable material useful in tissue removal or closure. For example, it can be made of a biodegradable material (e.g., polylactic acid, polyglycolic acid, polylactic-co-glycolic acid, etc.), or it can be made of a non-biodegradable material (e.g., metal, steel, polyester, nylon, propylene, silk, combinations thereof, etc.).

[0103] As the suture loop is tightened to close tissue, tissue may be pulled into the suture knot of the suture loop. If too much tissue is pulled into the suture knot, the suture knot may become blocked or clogged in a manner that prevents the suture loop from being tightened further. In some variations, the suture loop may include one or more cotton wool or tube segments to help protect a portion of the suture knot.

[0104] In some variations, the distal tip of the elongated body may include a suture loop cutting assembly (e.g., a suture cutter) configured to separate a tightened suture loop from the closure device. For example, a blade disposed in the distal tip may be used to cut a portion of a suture disposed within the distal tip to separate the suture loop from the closure device. Thus, in some variations, the closure devices described herein may deliver, tighten, and release a suture loop from the closure device without additional devices (e.g., cutting or otherwise severing the suture so that the suture loop may remain within the body after the closure device is removed). Figures 28A-28BA suture loop cutting assembly (e.g., suture cutter) (2810) disposed in a distal end (e.g., distal tip (2804)) of a closure device (2800) is depicted. The closure device (2800) may include an elongated body (2802) coupled to the distal tip (2804). The suture (2806) may extend through the distal tip (2804) and the corresponding lumens of the elongated body (2802). The suture loop cutting assembly (2810) may be disposed within a proximal portion of the distal tip (2804) and may include a cutting assembly housing (2812). The cutting assembly housing (2812) may define a first cutting assembly lumen (2818) and a second cutting assembly lumen (2820) that may be parallel to each other. At least a portion (e.g., an edge of a blade) of the suture cutter (2814) may be disposed within the second cutting assembly lumen (2820). For example, the suture cutter (2814) can be mounted on the upper surface of the cutting assembly housing (2812) at an angle relative to the longitudinal axis of the distal tip (2804) and extend into the second cutting assembly lumen (2820). In some variations, the length of the suture cutter (2814) can be between about 0.5 mm and about 1.3 mm. The suture (2806) can extend through the first cutting assembly lumen (2818). The control wire (2816) can extend through the second cutting assembly lumen (2820) and be attached or otherwise coupled to the suture (2806) within the distal tip (2804). For example, the control wire (2816) can be coupled (e.g., loosely) to the suture (2806) distal to the suture cutter (2814) and proximal to the suture loop and suture knot (not depicted). The control wire (2816) can extend through the control wire lumen in the elongated body (2802) and be coupled to an actuator in the handle (not shown). In some variations, thermal or RF energy can be used to cut the suture instead of a blade. For example, the suture loop cutting assembly (2810) can include an electrode or other device configured to generate thermal or RF energy, which can be used to cut the suture (2806).

[0105] The suture loop cutting assembly (2810) can be configured to cut the suture (2806) at a predetermined position (e.g., just distal to the attachment point with the control wire (2816) and proximal to the suture loop and suture knot) when the control wire (2816) is retracted in the proximal direction. For example, the distal end (e.g., pull wire) of the control wire (2816) can pull the suture (2806) upward toward the second cutting assembly lumen (2820) and into the second cutting assembly lumen. The suture cutter (2814) disposed within the second cutting assembly lumen (2820) can thus contact and cut the portion of the suture (2806) that is drawn into the second cutting assembly lumen (2820). When a retraction force (e.g., pulling force) is not applied to the control wire (2816), the suture (2806) will not contact the suture cutter (2814).

[0106] Keep components

[0107] When the snare ring assembly described herein includes a retaining member that releasably couples the snare and the suture loop, the retaining member can be any suitable member, such as a double-lumen tube. In some variations, a lumen can have a slit, perforation or other opening along its length, which can allow suture to pass through it when ready to be deployed. The slit does not need to extend or be continuous along the entire length of the retaining member. In some variations, the slit can have a fork or arm along its length to help capture and retain the suture in the retaining member. In other variations, the slit can be covered by a biodegradable polymer at a spaced-apart position, which can temporarily pin or press the suture. Of course, in still other variations, the retaining member may not include a slit, and may alternatively include some other types of retaining mechanisms, such as the fork or tack just described above. In yet other variations, there is no slit or opening in the retaining member, and the suture loop can be released when removing or extracting the retaining member.

[0108] Slender body

[0109] The closure device described herein generally comprises an elongated body. The elongated body can accommodate various components or parts thereof, such as a snare, a suture loop, a retaining member, a portion of an imaging device and a vacuum tube, and a conduit can be provided to connect these elements to a handle. As described above, the snare and the vacuum tube can slide within the elongated body so that the snare and the vacuum tube can be advanced and retracted relative to the elongated body.

[0110] In some variations, at least a portion of the elongated body can be flexible and / or steerable (e.g., using a pull wire or any other suitable steering mechanism), which can help facilitate navigation of the elongated body through the body to the target tissue. Utilizing a flexible and / or steerable elongated body can be particularly useful in situations where the target tissue is difficult to access during surgery because, for example, it may be beneath or covered by other anatomical structures.

[0111] In some variations, the elongated body can include various sections or portions having different characteristics, such as different diameters, cross-sectional shapes, stiffness, materials, etc., which can increase the manipulability and operability of the closure device. For example, the elongated body can be braided, non-braided, tapered, non-tapered, or some combination thereof. In some cases, at least a portion of the elongated body can be formable, meaning that the elongated body can be manipulated (e.g., bent) and can maintain the manipulated shape until a user or other applied force (e.g., from tissue within the body) further alters the elongated body.

[0112] Go to Figure 4B and 4C As shown, the elongated body (402) may include a tip (406) at its distal end. In some variations, the tip (406) of the elongated body (402) may be formed separately from the elongated body (402) and may be attached to the elongated body (402) using any suitable means (e.g., welding, using an adhesive, using a connector) during assembly of the closure device. In other variations, the tip (406) may be integral with the elongated body (402). The tip (406) may have the same number of lumens as the elongated body (402), but is not required. In some variations, the tip (406) may divide one or more lumens of the elongated (402) body into two or more sub-lumens. In other variations, the tip (406) may change the size or shape of one or more lumens of the elongated body (402).

[0113] The elongated body may include any suitable cross-sectional shape, such as circular, oval, D-shaped, triangular, etc. In some variations, the cross-sectional shape of the elongated body may vary along its length. For example, Figure 4DA perspective view of the distal end of an elongated body (402) having different portions is provided. The elongated body may include a proximal portion having a first cross-sectional shape (e.g., circular) and a distal portion having a second cross-sectional shape (e.g., D-shaped). Of course, the elongated body may include any suitable number of portions, such as two, three, or four portions, and the length of each portion may be the same or different from the other portions. The elongated body may further include one or more transition portions that connect portions of the elongated body including different diameters or different cross-sectional shapes. The elongated body and the vacuum tube may have different shapes, sizes, components, portions, and other characteristics, as described in more detail below. The closure device described herein may include any features or elements described in U.S. patent application No. 15 / 080,410, entitled "Device and Method for Left Atrial Appendage Closure" and filed on March 24, 2016, such as any elongated body configuration, the contents of which are hereby incorporated herein by reference in their entirety. For example, as described in more detail in U.S. Patent Application No. 15 / 080,410, the diameter and cross-sectional shape of the elongated body can be different along each of the cross-sectional lines FF, GG, and HH, as shown in the corresponding Figure 4F-4H and discussed in more detail below.

[0114] The elongated body described herein may include any suitable length and outer diameter, and the length and diameter of the elongated body may vary depending on the type of surgery performed. For example, in some cases, it may be desirable to limit the outer diameter of the elongated body so that it can be fitted through an 18-French percutaneous tube. In some variations, the outer diameter of the elongated body may also vary along its length. The elongated body may be made of any suitable material, for example, one or more polymers (e.g., polyether block amide, polyethylene, silicone, polyvinyl chloride, latex, polyurethane, PTFE, nylon, etc.).

[0115] Vacuum tube

[0116] As briefly mentioned above, the closure device described herein may include a vacuum tube. The vacuum tube can be configured to be slidably positioned relative to the elongated body so that the vacuum tube can be advanced and retracted relative to the elongated body. For example, the vacuum tube can be configured to fit within the lumen of the elongated body or slide near the elongated body. The vacuum tube can assist in direct visualization of tissue structures (e.g., for proper placement of the vacuum tube relative to the tissue in order to guide the closure element), identification and / or mapping of tissue structures, and stabilization of the closure device relative to the target tissue for advancing the closure element around the tissue. For example, an imaging device can be placed within the lumen of the vacuum tube, and a vacuum can be applied to tissue in contact with the vacuum tube to temporarily hold the left atrial appendage. In this way, the closure device and closure element guided to the left atrial appendage can be appropriately placed to achieve tissue closure without the need for a separate device, thereby improving the safety of the closure surgery and reducing its complexity.

[0117] Figure 4A is a perspective view of an illustrative variation of a closure device (400) comprising an elongated body (402), a snare loop assembly (404), a vacuum tube (430), and a handle (450). The handle (450) can be coupled to the elongated body (402) and the proximal end of the vacuum tube (430), and the vacuum tube (430) can be slidably positioned within the lumen of the elongated body (402) such that the handle (450) can be used to advance and retract the vacuum tube (430) relative to the elongated body (402). In some variations, the handle (450) can also be used to move the snare loop assembly (404) between open and closed configurations, control vacuum pressure applied to target tissue through the vacuum tube (430), control the operation and / or advancement of an imaging device (not depicted) positioned within the vacuum tube, and / or release a suture loop from the snare loop assembly.

[0118] Return to Figure 4B-4C In some variations, the vacuum tube (430) may include a proximal portion (not shown), a middle portion (442), a distal end (432), and a lumen (440) extending through the vacuum tube. The lumen (440) may have any configuration sufficient to provide negative pressure at the distal end (432) when the proximal end of the lumen (440) is coupled to a vacuum source. Figure 4B and 4C As shown, the diameter of the distal end (432) may be larger than the diameter of the middle portion (442) of the vacuum tube (430) located between the distal end (432) and the proximal end (not shown) of the vacuum tube (430) (e.g. Figure 4C, 4I). The middle portion (442) and the proximal portion of the vacuum tube (430) can be sized to fit within the lumen of the elongated body (402) and to retain one or more power and data conductors coupled to an imaging and / or sensing device within the lumen (440), as discussed in further detail below. The middle portion (442) of the vacuum tube (430) can further be flexible to manipulate the distal end (432) of the vacuum tube (430) toward a desired position. The distal end (432) can be sized to receive tissue when negative pressure is applied and can be atraumatic so that it does not tear, puncture, or otherwise damage the tissue when releasably coupled thereto. In some variations, the distal end (432) can include a conical, cup-shaped, or other concave configuration. In some of these variations, the distal end (432) can be configured to releasably couple to a tissue surface by suction when pressed against tissue (e.g., a suction cup). In others of these variations, distal end (432) may remain relatively rigid to assist in retaining target tissue.At least a portion of the proximal end of vacuum tube (430) may be slidably disposed within the lumen of elongate body (402).

[0119] In some variations, the distal end (432) of the vacuum tube (430) may include an anti-damage gripping element to physically engage the tissue and keep the tissue adjacent to the vacuum tube (430) without damaging the tissue. In some cases, the distal end (432) of the vacuum tube (430) may be configured to grip the tissue so that a seal is formed between the distal end (432) and the tissue. For example, the proximal end of the vacuum tube (430) may be coupled to a vacuum source, and the size and shape of the distal end (432) may be set so that a vacuum seal is temporarily formed when the distal end (432) of the vacuum tube (430) contacts the tissue and the vacuum source is activated. The distal end of the vacuum tube (e.g., a suction tip, a vacuum cup) may include a shape and size configured to form a vacuum seal between the distal end of the vacuum tube and the tissue having a predetermined attachment strength. For example, the distal end of the vacuum tube may have an opening height substantially equal to the height of the left atrial appendage tissue to fill the lumen of the distal end of the vacuum tube so that a vacuum seal can be formed. The strength of the vacuum force holding the distal end to the cardiac tissue can be proportional to the area of ​​the opening at the distal end, assuming the opening is substantially blocked by tissue to form a vacuum seal. In some variations, the suction tip of the vacuum tube can be configured to grasp and / or surround the left atrial appendage. In other variations, the suction tip of the vacuum tube can include one or more shapes and / or soft shells (e.g., bags, balloons) to surround at least a portion of the left atrial appendage. For example, an expandable bag at the suction tip can be inflated to push the left atrial appendage against other cardiac tissue, thereby maintaining the left atrial appendage in an appropriate position therebetween.

[0120] In some variations, the suction tip of the vacuum tube may be configured to provide visualization via an imaging device positioned in the vacuum tube, and to provide stabilization by applying a vacuum suction force. Fig.19 is a perspective view of another variation of vacuum tube (1900) including distal aspiration tip (1902), vacuum tube (1904), Y-arm (1906), and imaging device (1912) (e.g., a camera, endoscope, fiberscope, external light source and imaging sensor, ultrasound catheter, etc.). Imaging device (1912) may be fixed relative to the vacuum tube or may be slidably positioned within the lumen of vacuum tube (1904). Fig.19 The vacuum tube (1904) depicted in can be slidably positioned within the lumen of an elongated body (not shown) of a vacuum tube as described herein. The proximal end of the Y-shaped arm (1906) can be coupled to a first seal (e.g., a Tuohy-Borst type seal), which can be configured to prevent vacuum from escaping the proximal end of the vacuum tube (1900). The seal can allow an imaging device (e.g., a cable coupled to the distal end of the imaging device) to be positioned in the vacuum tube lumen, which can be used to transmit negative pressure to the suction tip. As described in more detail herein (e.g., Figures 38A-38C and 39A-39B), a second seal may be positioned proximal to the first seal to further improve the vacuum seal.

[0121] Although not shown, a handle can be coupled to the proximal end of the elongated body (1904). The handle can also be used to control one or more of the vacuum pressure applied to the target tissue through the elongated body (1904) and the operation and / or advancement of an imaging device (1912) positioned within the elongated body (1904). The Y-shaped arm (1906) can be used to couple the proximal end of the elongated body (1904) to a vacuum source (e.g., an electronic or mechanical vacuum pump), as described in more detail herein. The proximal end of the imaging device (1912) can include an imaging device connector (1914), which can be configured to couple the imaging device (1912) to a device that can process and / or display images used during surgery (e.g., an image processor and memory, a user console, a display, a remote network, etc.).

[0122] In some variations, the suction tip of the vacuum tube may physically engage tissue adjacent to the vacuum tube by applying a vacuum suction force to the tissue. Fig. 20is a perspective view of a variation of an aspiration tip (2004) of a vacuum tube (2000). The vacuum tube (2000) may include an elongated body (2002) coupled to the aspiration tip (2004). The aspiration tip (2004) may be coupled to the distal end of the elongated body (2002). In some variations, the aspiration tip (2004) may be formed separately from the elongated body (2002) and may be attached to the elongated body (2002) using any suitable means (e.g., welding, using an adhesive, using a connector) during assembly of the vacuum tube (2000). In other variations, the aspiration tip (2004) may be integral with the elongated body (2002). An imaging device (2008) may be slidably positioned or fixed within the lumen of the aspiration tip (2004) and the elongated body (2002) as described herein. The aspiration tip (2004) may include an oblong cup (2006). The oblong cup (2006) can be configured to couple with tissue (not shown) by providing a vacuum seal around the circumference of the opening (2010) when a vacuum suction force is applied. The surface area of ​​the suction tip (2004) can be increased by increasing the length of the opening (2010) relative to its width. The height of the oblong cup (2006) can be approximately equal to the thickness of the left atrial appendage or the target tissue to be suctioned. In some variations, the outer width of the oblong cup (2006) can be less than about 20 French, and the inner surface height of the oblong cup (2006) can be between about 2 mm and about 3 mm. The oblong cup (2006) within these dimensions can contact tissue along the entire circumference of the opening (2010), and thus provide an increased vacuum retention force relative to the opening of the suction tip (2004) of the elongated body (2002) with a smaller surface area. In some variations, the diameter of the oblong cup (2006) can be up to about 20 French.

[0123] In some variations, the oblong distal tip (2006) may comprise a rigid polymer (e.g., stainless steel, plastic (such as ultem), ABS, polycarbonate, combinations thereof, etc.), while one or more portions of the vacuum tube (2002) may comprise a more flexible material (e.g., reinforced polyetheramide (pebax), polyimide, polyurethane, combinations thereof, etc.). Additionally or alternatively, in some variations, the vacuum tube (2002) may comprise a braided polyimide and / or a stainless steel wire braid having relatively stiff walls configured to maintain its shape under negative pressure.

[0124] In some variants, the suction tip of the vacuum tube can be configured to transition between a contraction configuration and an expansion configuration, which can assist the vacuum tube to advance through the lumen and can increase the cross-sectional area of ​​the tissue that can be aspirated. In the contraction configuration, the cross-sectional area of ​​the suction tip can be minimized to allow the vacuum tube to advance through the sheath (e.g., cannula) so that the vacuum tube is delivered to the pericardial cavity. Once the vacuum tube advances to leave the sheath and enter the pericardial space, the suction tip can be transformed into an expansion configuration with a larger diameter or transverse dimension than the lumen of the sheath. The expanded vacuum tube can be configured to suck a larger volume of tissue into the lumen of the suction tip. The suction tip can then be transformed back to the contraction configuration in order to retract and extract from the patient. As described in detail herein, the suction tip can use any suitable mechanism, such as a fluid-based mechanism or mechanical mechanism to transform between contraction or delivery / extraction and expansion / deployment configuration. In some variants, the suction tip can be self-expanding (e.g., naturally biased toward the expansion configuration). For example, the suction tip can include a shape memory material (e.g., a nickel-titanium alloy) or other materials that are biased toward an expanded configuration that can advance through the lumen of an elongated body or sheath and be constrained therein. When advancing out of the lumen, the suction tip can naturally transform into an expanded configuration. One or more portions (e.g., a proximal portion) of the suction tip can be angled in the expanded configuration so that the suction tip can be retracted into the lumen and constrained again (e.g., to reform a contracted configuration).

[0125] Figures 25A-25B Depicted are variations of vacuum tubes that can be transformed between a contracted configuration and an expanded configuration using a fluid. For example, Figures 25A-25B The distal end of the vacuum tube depicted in (e.g., suction tip, vacuum cup) can be filled with a fluid to rigidify the suction tip and allow tissue to be drawn into a cavity formed in the suction tip. In some variations, at least the suction tip of the vacuum tube can be advanced in a first configuration (e.g., retracted, compact, rolled up, compressed, delivered) and then expanded into a second configuration (e.g., rigid, expanded, inflated, deployed) once the target tissue is reached, wherein the suction tip in the second configuration can be configured to physically engage tissue adjacent to the suction tip by applying a vacuum suction force to the tissue. Fig.25A As shown in the cross-sectional side view of , the vacuum tube (2500) can include an elongated body (2502) including a first lumen (2504) and a second lumen (2506). The second lumen (2506) can be disposed within the first lumen (2504) such that the second lumen (2506) has a smaller outer diameter than the first lumen (2504). That is, the second lumen (2506) can be concentric with the first lumen (2504) or otherwise configured to be nested within the first lumen. In some variations, the inner diameter of the second lumen (2506) can be between about 2 mm and about 3 mm. Figures 25A-25B The suction tip (2510) of the vacuum tube (2500) in the second configuration is shown, wherein the shape of the suction tip can be roughly conical (e.g., funnel, cup), cylindrical, oblong, polygonal, etc. The suction tip (2510) may include an opening (2514) having a distal diameter greater than the distal diameter of the second lumen (2506). In some variations, the first lumen and the second lumen do not need to be concentric with each other. For example, the second lumen may include a set of two crescent-shaped lumens arranged around a central first lumen. In some variations, the crescent-shaped lumens may be located on opposite sides of the first lumen (e.g., on the top and bottom, on the left and right sides).

[0126] In some variations, the suction tip (2510) may include a soft shell (e.g., a bag, a balloon) that includes a third lumen (2512) (e.g., a distal lumen). The distal end of the first lumen (2504) may be coupled to the third lumen (2512) and communicate with the third lumen fluid so that the third lumen (2512) can be expanded using a fluid directed through the first lumen (2504). The distal end of the second lumen (2506) may be coupled to the opening (2514) of the suction tip (2510). In some variations, the proximal end of the elongated body (2502) may be coupled to a Y-shaped arm (not shown) and configured to slidably position the second lumen (2506) relative to the first lumen (2504). In some variations, the positioning of the second lumen (2506) may be fixed relative to the first lumen (2504) using, for example, a proximal portion (2520) of the suction tip (2510). Additionally or alternatively, first lumen (2504) and second lumen (2506) may be fixed relative to each other at the handle.For example, in a first configuration, second lumen (2506) may be withdrawn from the distal end of elongated body (2502).

[0127] As described above, the suction tip can be transformed from the first configuration to the second configuration using a fluid. The first lumen (2504) and the third lumen (2512) in the first configuration may be free of fluid (e.g., gas, liquid). In this way, the suction tip (2510) may include a compression or low profile shape with a smaller spatial volume, and may therefore easily pass through a sheath and / or an elongated body (not shown) to advance. For example, the suction tip (2510) in the first configuration may be compressed so that the distal portion of the suction tip (2510) may be folded on itself or otherwise formed into a lower profile so that it may be assembled in the lumen of a smaller sheath. In other words, the suction tip (2510) may be in a foldable state. Once the first lumen (2504) and the aspiration tip (2510) are positioned at a predetermined location (e.g., at or adjacent to the target tissue), the second lumen (2506) can be slidably advanced within the first lumen (2504) to couple to the aspiration tip (2510) (e.g., such that the second lumen (2506) is flush with the proximal end of the aspiration tip). The first lumen (2504) can be coupled to a fluid source (e.g., an injector filled with a fluid) and can then be filled with a fluid (e.g., saline, contrast agent, CO2, and combinations thereof), which flows into and fills the third lumen (2512) of the aspiration tip (2510) with the fluid, thereby transforming the aspiration tip (2510) from the first delivery configuration to a second deployed configuration, in which the aspiration tip can be rigid, expanded, and / or inflated. The fluid flowing through the first lumen (2504) and into the third lumen (2512) is then moved to a position where the aspiration tip (2510) is in a state of being ... Fig.25A , depicted by solid arrows. Small bubbles may be present in one or more of the first lumen (2504) and the third lumen (2512) without negatively affecting the rigidity of the vacuum tube (2500). The second lumen (2506) and the opening (2514) may form a working channel through which suction may be applied and / or a device (e.g., an imaging device) may be advanced. For example, Fig.25A A vacuum suction force is depicted being applied within opening (2514) and second lumen (2506).

[0128] In some variations, the pressure (e.g., fluid pressure) of the first lumen (2504) and the third lumen (2512) in the second configuration can be at least equal to the suction force applied by the opening (2514) through the second lumen (2506) and the suction tip (2510). In some variations, the suction tip (2510) can be configured to withstand a pressure of up to about 400psi (or 27atm) before failure (e.g., before the soft shell leaks and / or bursts). The suction tip can be made of any suitable material or combination of materials. For example, in some variations, the suction tip can include a balloon made of nylon, polyethylene terephthalate, a combination thereof, and the like. When the suction tip expands in the second configuration, the suction tip can be configured to present a specific shape or configuration. For example, when in the second configuration, the suction tip can form a roughly conical, rhombus, spherical, pyramidal, and other shapes. In some variations, the aspiration tip can be translucent, opaque, and / or colored (e.g., as a visual marker for an imaging device). In some variations, the aspiration tip and / or one or more portions of the elongated body can be radiopaque and / or include radiopaque materials and / or markers.

[0129] In some variations, an operator may use a vacuum tube that may be mechanically transformed between a retracted configuration and an expanded configuration. Figures 33A-33D Depicted are variations of a suction tip of a vacuum tube that can be mechanically manipulated to transition between a retracted configuration and an expanded configuration. Fig.33A The aspiration tip (3300) is shown coupled to a vacuum tube (3302). The aspiration tip (3300) may include a distal hub (3304) coupled to a frame (3310) covered by a cover (3306) (in Fig.33A The distal hub (3304) and / or the cover (3306) may be coupled to the vacuum tube (3302) via a seal (3308).

[0130] Fig.33B The aspiration tip is depicted with the cap (3306) removed for clarity. Fig.33BAs shown, the hub (3304) can be fixed to the outer diameter of the vacuum tube (3302). The hub (3304) can include a first hub lumen (3305) operatively coupled to the lumen of the vacuum tube (3302). The frame (3310) can include a set of first support members (3312) (e.g., a pair of longitudinal struts) and a set of second support members (3314) (e.g., a pair of longitudinal struts). The support members (3312, 3314) can be parallel to the longitudinal axis of the suction tip (3300). The second support member (3314) can include one or more curved portions (3315) along the length of the suction tip. The first support member (3312) can advance and retract along the longitudinal axis of the suction tip (3300), while the second support member (3314) can move laterally relative to the longitudinal axis of the suction tip (3300). A set of support connectors (3316) can be coupled between adjacent first and second support members (3312, 3314). For example, the support connectors can include elongated metal or hard plastic struts that are angled relative to the longitudinal axis. One or more control wires (3320) (e.g., a pair of pull wires) can extend through the vacuum tube (3302) and the distal hub (3304) (e.g., positioned within the lumen or corresponding lumens of the vacuum tube and the distal hub) and couple to the first support member (3312) of the frame (3310). In variations using multiple control wires (3320), the control wires (3320) can be operated independently. As Fig.33B As shown, the distal end of the control wire (3320) can be coupled to the proximal end of the first support member (3312). The advancement and retraction of the control wire (3320) can change the configuration of the frame (3310) and thus the configuration of the suction tip by moving the first support member (3312) longitudinally and the second support member (3314) laterally, as described in more detail herein. The geometry of the frame assembly is such that when the second support member (3314) moves laterally, the second support member (3314) remains parallel to the first support member (3312).

[0131] The proximal portion of each of the second support members (3314) can be coupled to a ramp (3318) (e.g., a triangular or wedge-shaped plate) configured to slide along the distal side of the hub (3304). When the frame (3310) is transformed into an extended configuration, each ramp (3318) can force the second support member (3314) to shift laterally relative to the longitudinal axis of the suction tip (3300). When the frame (3310) is transformed into an extended configuration, the support connector (3316) can bend away from the first support member (3312) and store spring energy. The control wire (3320) can be released, allowing the second support member (3314) to relax and come together, thereby pulling the second support member (3314) back to the contracted configuration.

[0132] Fig.33C 3306. The vacuum tube (3302) may include a plurality of lumens, the plurality of lumens comprising a first vacuum tube lumen (3330) and a second vacuum tube lumen (3332). In some variations, an imaging device (e.g., a camera, an endoscope, a fiberscope, an ultrasound catheter, etc.) may be disposed within the first vacuum tube lumen (3330), and a vacuum suction force may be applied through the first vacuum tube lumen (3330). The control wire (3320) may be disposed in the second vacuum tube lumen (3332). The distal hub (3304) may include a first hub lumen (3305) and a second hub lumen (3307). The first hub lumen (3305) can be operatively coupled to the first vacuum tube lumen (3330), and the second hub lumen (3307) can be operatively coupled to the second vacuum tube lumen (3307). A control wire (3320) can slide within the second hub lumen (3307). One or more control wires (3320) can extend to the proximal end of the vacuum tube (3302) and be coupled to an actuator (not shown) (e.g., an actuator disposed in a handle). Fig.33D is a front view of the aspiration tip (3300) of the vacuum tube (3302) in a retracted configuration sized to slide within the lumen of the sheath (3350).

[0133] Figures 34A-34C The aspiration tip (3402) of the vacuum tube (3400) (with and without a cover) is shown advancing away from the sheath (3404) in various configurations. Fig.34A The aspiration tip (3402) is depicted in a retracted configuration in which it is configured (e.g., sized) to slide within the lumen of the sheath (3404). The control wire of the aspiration tip may be in a fully distal position. Fig.34BIn the embodiment of the present invention, the aspiration tip (3402) is partially expanded to an intermediate configuration. In this configuration, the width of the aspiration tip (3402) can be greater than the diameter of the sheath (3404), and the control wire can be in a partially retracted position. Fig.34C , the suction tip (3402) is in a fully extended configuration. In this configuration, the control wire is in a fully proximal position and the suction tip (3402) is in a fully extended configuration. The fully extended configuration has the largest cross-sectional area (length and width) relative to the retracted configuration and the intermediate configuration, thereby providing a larger surface area for tissue contact. The vacuum suction force may be applied to the vacuum tube (3400) and the suction tip (3402) in any of the aforementioned configurations, however, the vacuum suction force may be most effective in the fully extended configuration where the suction tip is configured to contact the largest surface of tissue relative to other configurations.

[0134] In some variations, the suction tip may include any suitable length, and the length of the suction tip may vary depending on the type of surgery performed. In some variations, the length of the suction tip may be between about 10 mm and about 25 mm. In some variations, the expansion and contraction ratio of the width of the suction tip may be about 2 to 1 (i.e., the width of the suction tip may be about twice as large in the contracted configuration in the expanded configuration). The cover of the suction tip may be made of any suitable material, for example, one or more compliant flexible materials, including but not limited to low hardness silicone, thermoplastic elastomer, combinations thereof, etc. The frame of the suction tip may be made of any suitable material, for example, one or more rigid materials, including but not limited to stainless steel, nickel-titanium alloys, rigid polymers (e.g., polyimide, polyetherimide), combinations thereof, etc.

[0135] Fig. 7A is a perspective view of a variation of the suction tip (700) of the vacuum tube, and Figure 7BA suction tip (700) coupled to a tissue (750) is depicted. In this variation, the suction tip (700) may include an oblong cup (704) and a connector (702) configured to be coupled to a vacuum tube (not shown). The oblong cup (704) may be configured to couple to the tissue (750) by providing a vacuum seal around the circumference of the opening (705). The surface area of ​​the suction tip (700) of the vacuum tube may be increased by increasing the length of the opening relative to its width. For example, the aspect ratio of the oblong cup (704) may be between about 4:1 and about 1.5:1. In one variation, the aspect ratio of the oblong cup (704) may be about 3:1. The oblong cup (704) within these ratios may contact the tissue (750) along the entire circumference of the opening (705), and thus provide an increased vacuum retention force relative to the opening of the suction tip of the vacuum tube having a smaller surface area. Connector opening (703) can be perpendicular to oblong opening (705) so that suction can be provided in a direction perpendicular to the lumen of connector (702). This configuration can bring the closure device closer to tissue (750), which can reduce the distance the snare ring assembly needs to travel to advance over tissue (750). For example, a closure device configured to couple to a longitudinal side of tissue (750) (e.g., Figure 7B The suction tip (700) of the oblong suction tip (700) can bring the closure device closer to the left atrial appendage than when coupled to the apex (752) of the left atrial appendage. In some variations, the oblong suction tip (700) can include a rigid polymer having a height between about 0.20 cm and about 1.0 cm, a width between about 0.20 cm and about 1.50 cm, and a length between about 1.0 cm and about 3.0 cm. In other variations, the aspect ratio of the oblong suction tip (700) can be between about 15:1 and about 1.5:1. In one variation, the aspect ratio of the oblong suction tip (700) can be about 5:1. In another variation, the aspect ratio of the oblong suction tip (700) can be about 2:1. In yet another variation, the aspect ratio of the oblong suction tip (700) can be about 2.5:1. In some variations, oblong suction tip (700) may comprise a height of approximately 0.60 cm, a width of approximately 0.80 cm, and a length of approximately 2.0 cm.

[0136] In other variations, the suction tip of the vacuum tube may physically engage tissue adjacent to the vacuum tube by physically grasping the tissue and optionally applying a vacuum suction force to the tissue. Figure 7C is a perspective view of the suction tip (710) of the vacuum tube, and Fig.7DA suction tip (710) of a vacuum tube coupled to tissue (750) is depicted. In this variation, the suction tip (710) of the vacuum tube (700) is in the form of a clamp comprising a U-shaped portion (714) and a connector (712) configured to couple to a vacuum tube (not shown). The U-shaped portion (714) may comprise a first arm (718), a second arm (720), and a plurality of protrusions (716) disposed along an interior surface of the U-shaped portion (714). The first and second arms (718, 720) and the protrusions (716) are configured to retain tissue (750) but not tear, puncture, or damage tissue (750) by forming an atraumatic surface and edges (e.g., rounded, blunt) to seal the tissue without causing damage. For example, as Fig.7D As shown, the opening of the U-shaped portion (714) (i.e., the distance between the first arm and the second arm (718, 720)) can be approximately equal to the height of the tissue (750). The U-shaped portion (714) can be advanced so that the first arm (718) is located on the first side of the tissue and the second arm (720) is located on the second opposite side of the tissue. In this way, the U-shaped portion (714) can close a portion of the tissue (750) and can be temporarily coupled to the tissue (750) using the suction force provided by the connector (712). Once the tissue has been captured by the suction tip (710), the U-shaped portion (714) and the protrusion (716) can hold the tissue and provide resistance to the movement of the tissue (750). In some cases, the width and height of the suction tip (710) can be approximately equal to the width and height of the left atrial appendage. The U-shaped portion (714) can further include rounded edges to reduce trauma to the tissue. In other variations, the length of the U-shaped portion (714) can be shorter so as to form a C-shape or a V-shape. In some variations, aspiration tip clamp (710) may comprise an elastomeric polymer having a durometer (Shore) of approximately 50 A. It will be appreciated that an imaging device may be disposed in vacuum tube or connector (712) and may provide visualization of tissue (750) captured by U-shaped portion (714).

[0137] In yet another variation, the aspiration tip of the vacuum tube can be advanced in a first configuration (e.g., compact, rolled up, compressed) and then expanded into a second configuration (e.g., expanded, inflated), wherein the second configuration of the aspiration tip of the vacuum tube is configured to physically engage tissue adjacent to the vacuum tube by applying a vacuum suction force to the tissue. For example, at least a portion of the aspiration tip of the vacuum tube can be expanded to press one side of tissue, such as the left atrial appendage, against cardiac tissue on an opposite side of the left atrial appendage. Fig. 7Eis a perspective view of a deformable suction tip (720) of a vacuum tube including a connector (722) coupled to a base (724) and a vacuum portion (726). The suction tip (720) may be configured to be coupled to a vacuum tube (not shown). Figure 7F A deformable suction tip (720) is depicted coupled to tissue (750). A vacuum portion (726) and a ring portion (728) can be disposed in a base (724). In some variations, the base (724) of the deformable suction tip (720) can include an elastomeric polymer having a hardness (Shore) of approximately 27A. This allows the base (724) to be deformed into a smaller volume (not shown) (e.g., rolled up, compressed), such as during advancement of the vacuum tube in the body. Once in the desired position, pressure can be applied to the ring portion (728) to expand the deformable suction tip and / or rigidify it. Negative pressure can then be applied to the vacuum portion (726) to aspirate the tissue. Although in Fig. 7E and 7F , but it will be appreciated that the base 724 may have any suitable cross-sectional shape, such as a rectangle, square, oval, triangle, diamond, etc. In this variation, the connector (722) may be coupled to a middle portion of the vacuum tube, which may include at least a first vacuum tube lumen for providing negative pressure and a second vacuum tube lumen for providing positive pressure. The connector (722) may include at least a first suction tip lumen (730) operably coupled to the first vacuum tube lumen of the vacuum tube and a second suction tip lumen (732) operably coupled to the second vacuum tube lumen of the vacuum tube. Thus, in this variation, the first suction tip lumen (730) may provide negative pressure to the vacuum portion (726), and the second suction tip lumen (732) may provide positive pressure to the ring portion (728) of the base (724). As Fig. 7E , the connector (722) of the suction tip (720) can also include a third suction tip lumen (734) that can provide positive pressure to the ring portion (728). Positive pressure can be provided to the suction tip (720) and the ring portion (728) by a positive pressure source having a fluid including a gas and / or a liquid. In some variations, the vacuum portion (726) can draw suction to the tissue.

[0138] Figures 24A-24D A variation of a vacuum tube comprising holes and an aspiration tip is depicted.The vacuum tube (2400) may comprise a plurality of holes (2406) at the aspiration tip (2404). Figures 24A-24C A vacuum tube (2400) is shown having an aspiration tip (2404) comprising a pair of elongated members (2404) each defining a plurality of apertures (2406) configured to apply a vacuum / suction force to tissue (not shown). Fig.24A and 24C shows the U-shaped distal end, while Fig. 24B The V-shaped distal end is shown. Fig.24A The suction tip (2404) in is rounded, and Fig.24C In some embodiments, the elongated member (2404) may be arranged to form a right angle with the suction tip (2404) in the left atrial appendage. In some embodiments, the spacing between the elongated members (2404) may be configured to surround the left atrial appendage so that it remains in a proper position relative to the vacuum tube (2400) without compressing and / or squeezing the left atrial appendage. In some embodiments, the suction tip may be positioned above and / or below the left atrial appendage to hold the tissue (e.g., the left atrial appendage may rest on the suction tip, or the suction tip may rest on the left atrial appendage). Alternatively, the elongated member (2404) may be positioned to be located on top of the tissue (e.g., left atrial appendage, pericardium) so that the tissue may be suctioned into contact with the hole (2406) and therefore with the suction tip.

[0139] In some variations, the aspect ratio of the suction tip (2404) can be between about 4:1 and about 1.5:1. In one variation, the aspect ratio of the suction tip (2404) can be about 3:1. In other variations, the aspect ratio of the suction tip (2404) can be between about 15:1 and about 1.5:1. In one variation, the aspect ratio of the suction tip (2404) can be about 5:1. In another variation, the aspect ratio of the suction tip (2404) can be about 2:1. In yet another variation, the aspect ratio of the suction tip (2404) can be about 2.5:1. In some variations, the suction tip (2404) can include a height of about 0.60 cm, a width of about 0.80 cm, and a length of about 2.0 cm. In some variations, the height of the aspiration tip (2404) may be between about 0.20 cm and about 1.0 cm, the width between about 0.20 cm and about 1.50 cm, and the length between about 1.0 cm and about 3.0 cm.

[0140] Fig.24D A vacuum tube (2400) is shown that includes a single elongated member (2402) and a plurality of apertures (2406). For example, the aspiration tip may include two, three, four, five, six, seven, eight, or more apertures, including all values ​​and subranges therebetween. Fig.24D The vacuum tube (2400) in the can be configured to generate suction through a set of selected holes to aspirate the myocardial tissue near the left atrial appendage. Additionally or alternatively, the vacuum tube (2400) can aspirate the left atrial appendage itself.

[0141] In some embodiments, the suction tip (432) of the vacuum tube (430) may include a different material than the middle portion (442) of the vacuum tube (430). For example, in some variations, the suction tip (432) of the vacuum tube (430) may be formed from a material that is more rigid than the material used to form the more proximal portion of the vacuum tube. In these variations, the proximal portion and / or the middle portion of the vacuum tube (430) may be flexible (e.g., configured to bend), which may assist in manipulating the suction tip (432) of the vacuum tube (430) to a desired position, while the suction tip (432) of the vacuum tube (430) may be rigid such that the suction tip (432) of the vacuum tube (430) remains open and is configured to receive tissue when a vacuum is applied. For example, the suction tip (432) of the vacuum tube (430) can be formed of a rigid material (e.g., stainless steel, plastic (such as ultem), ABS, polycarbonate, etc.), and the proximal portion and / or the middle portion of the vacuum tube (430) can include a more flexible material (e.g., reinforced polyetheramide, polyimide, polyurethane, etc.). In another example, the proximal portion and / or the middle portion of the vacuum tube can include a braided polyimide and / or a stainless steel wire braid having a relatively stiff wall configured to maintain its shape under negative pressure.

[0142] In some variations, the vacuum tube (430) may include various sections or portions having different properties (e.g., hardness, cross-sectional shape, diameter, etc.) to assist in manipulating the vacuum tube and / or closure device within a confined space such as a body cavity. For example, in some variations, the vacuum tube may include a proximal portion and / or a middle portion (442) comprising a wall having a reduced thickness relative to the suction tip of the vacuum tube. This may result in the proximal portion and / or the middle portion (442) of the vacuum tube being flexible, which may aid in advancement through the pericardial space. It should be understood that the vacuum tube (430) may be manipulable (e.g., using a pull wire) with or without the use of an imaging device.

[0143] The vacuum tube may be slidably positioned within the lumen of the elongated body. Specifically, the lumen of the elongated body may at least partially surround the vacuum tube. Figure 4C As shown, vacuum tube (430) may extend from elongated body (402). It should be understood that the lumen of the elongated body through which the vacuum tube may extend may form a portion of the lumen (e.g., a groove, a channel, a recess) at the distal end of the elongated body (e.g., Figure 4D As shown in FIG. 4A ) or may extend to and / or beyond the tip (406) of the elongated body. Figure 4C-4D The partial lumen shown may, in some cases, provide improved flexibility to aid in manipulating and / or guiding the closure device along the vacuum tube.

[0144] Fig. 4I is a cross-sectional side view of a variation of a vacuum tube (430) and an elongated body (402). As shown, the elongated body (402) may include a tip (406) and a snare ring assembly (404) extending from its distal end. The vacuum tube (430) is shown extending through the snare ring assembly (404). In some cases, the vacuum tube (430) may be advanced out of the elongated body (402) through a hole (408) formed by the snare ring assembly (404). In some variations, at least a portion of the vacuum tube may have been positioned through the snare ring (e.g., the snare ring may be positioned around the vacuum tube) prior to inserting the closure device into the body. As described above, the vacuum tube (430) may include a lumen (440) extending from the suction tip (432) to the proximal end of the vacuum tube (430), and the proximal end of the lumen (440) may be operably connected to a vacuum pump (not shown) configured to generate a negative pressure in the lumen (440) and provide a suction force at the suction tip (432) of the vacuum tube (430).

[0145] Any suitable vacuum pump can be used, for example, an electric vacuum pump (e.g., an aspirator), a mechanical vacuum pump, etc. In some cases, the vacuum pump can be part of a central vacuum system integrated into a medical facility, wherein the central vacuum system utilizes a large vacuum pump and a vacuum reservoir to provide negative pressure to multiple rooms. In these variations, the proximal end of the lumen (440) can be coupled to a wall outlet that can provide the negative pressure generated by the central vacuum system. The force generated in the vacuum tube (430) can be at least enough to pull the tissue toward the suction tip (432) of the lumen (440) so that the vacuum tube (430) can remain against the tissue. For example, a vacuum pump can generate a negative pressure between about 480 mmHg and about 635 mmHg. In some cases, a vacuum pump can generate a negative pressure of about 560 mmHg. In other cases, a vacuum pump can generate a negative pressure of about 440 mmHg. Tissue retention or adhesion can be between about 0.25 lbf and about 1.0 lbf. In some variations, the tissue retention force may be between about 0.10 lbf and about 0.41 lbf, between about 0.10 lbf and about .33 lbf, between about 0.20 lbf and about 0.40 lbf, or may be about 0.33 lbf. For example, in one variation, the tissue retention force may be between about 0.06 in. 2 The vacuum tube of the suction tip can be used with a vacuum pump to generate a negative pressure of about 560 mmHG, which can generate a tissue retention force of about 0.65 lbf. In another variation, the area is about 0.04 in 2The suction tip can be used with a vacuum pump to generate a negative pressure of about 560 mmHg, which can generate a tissue retention force of about 0.42 lbf. In another case, the vacuum pump can generate a negative pressure of about 440 mmHg, which can generate a tissue retention force of about 0.33 lbf.

[0146] In some variations, the vacuum tube and the elongated body may be coupled to a handle of a closure device without positioning the vacuum tube within the lumen of the elongated body. Figure 5A-5B A side view of a closure device (500) is depicted, comprising an elongated body (502), a snare loop assembly (504), a vacuum tube (530), and a handle (550). The handle (550) may be coupled to the proximal end (540) of the elongated body (502) and the vacuum tube (530). Figures 4A-4I Compared to the closure device (400) depicted in the embodiment of the present invention, a portion of the vacuum tube (530) is not disposed within the lumen of the elongated body (502). Instead, the vacuum tube (530) can be slidably positioned near the elongated body (502) so that the handle (550) can be used to advance and retract the vacuum tube (530) relative to the elongated body (502). For example, the vacuum tube (530) can extend through the proximal end of the handle (550) and withdraw from it. The operator can grasp the proximal end of the vacuum tube (530) to advance and / or retract the vacuum tube (530). The handle (550) can include a snare control (552) and a vacuum tube control (554) to respectively operate the snare and control the vacuum function of the closure device (500). In some variations, the vacuum tube control (554) can also control the advancement and / or retraction of the vacuum tube (530) (e.g., using a slider, knob, button, switch, etc.). As discussed in more detail below, handle (550) may be used to move snare loop assembly (504) between an open configuration and a closed configuration, manipulate elongated body (502) and vacuum tube (530), control vacuum pressure applied to target tissue via vacuum tube (530), control the operation and / or advancement (e.g., of imaging device (570) positioned within vacuum tube (530), and / or Figure 5B ), and / or release a suture loop from snare loop assembly (504). The proximal end of handle (550) may include a vacuum connector (556) and an imaging device connector (558), as discussed in further detail below.

[0147] Figure 6 600 includes a middle portion (602) and an aspiration tip (604). The aspiration tip (604) of the vacuum tube (600) can be coupled to the middle portion (602) of the vacuum tube (600) in any suitable manner. For example, Figure 6, the proximal side of the suction tip (604) of the vacuum tube (600) can be tapered and coupled (e.g., welded, using an adhesive, using a connector) to the suction tip of the middle portion (602) of the vacuum tube (600). In other variations, the suction tip (604) of the vacuum tube (600) and the middle portion (602) of the vacuum tube (600) can be integrally formed. An imaging device (610) can be disposed within the lumen (606) of the suction tip (604) of the vacuum tube (600) and can be configured to provide visualization of tissue (not shown). The imaging device (610) can be located at a predetermined distance from the opening of the suction tip (604) of the vacuum tube (600) to provide a buffer between tissue (e.g., cardiac tissue) drawn into the opening of the suction tip (604) of the vacuum tube (600) and positioned within the lumen (606) of the vacuum tube (600) and the imaging device (610). Power and data conductors (not shown) can extend from the imaging device (610) through the vacuum tube (600) to at least one handle (not shown). The lumen (606) of the vacuum tube (e.g., the middle portion (602) and the suction tip (604)) can be sufficiently sized so that the imaging device (610) and the power and data conductors can be positioned within the lumen (606) of the vacuum tube (600), and vacuum can still be transmitted from the vacuum pump through the lumen (606) of the vacuum tube (600) to the suction tip (604) of the vacuum tube (600).

[0148] In some variations, the vacuum tube may be slidably adjacent to the elongated body and may be coupled together using a coupling element (e.g., a fastener) configured to slidably retain a portion of the vacuum tube relative to a corresponding portion of the elongated body. This may help ensure that the snare loop and the vacuum tube are aimed in the same direction and may assist in positioning the devices relative to each other. Figures 26A-26B A perspective view of a closure device (2600) is depicted, comprising an elongated body (2602), a vacuum tube (2604), an imaging device (2610), and a fastener (2620). The elongated body (2602) can define a plurality of lumens therethrough, wherein the snare loop can extend beyond a first lumen, and the vacuum tube (2604) can be slidably disposed within and extend beyond a second lumen of the elongated body (2602). The cross-sectional shape of the elongated body (2602) can vary along its length, as described in more detail above. For example, a distal portion of the elongated body (2602) can include a D-shaped cross-section, and a proximal portion of the elongated body (2602) can include a circular cross-section. The vacuum tube (2604) can, for example, extend into a lumen (e.g., Fig.26AThe operator can grasp the proximal end of the vacuum tube (2604) to advance and / or retract the vacuum tube (2604). In some variations, the elongated body (2602) and the vacuum tube (2604) can be coupled to a handle (not shown) that includes a snare control and a vacuum tube control as described herein. For example, the vacuum tube control can be configured to use an actuator (e.g., a slider, a knob, a button, a switch, etc.) to control the advancement and / or retraction of the vacuum tube.

[0149] The suction tip (2606) of the vacuum tube (2604) may be coupled to an imaging device (2610) or otherwise configured to hold the imaging device, and may further include a shape for assisting in suctioning tissue, such as Figures 27A-27F , which will be described in more detail below. The imaging device (2610) can be positioned within the lumen of the suction tip (2606) of the vacuum tube (2604) and can be configured to provide visualization of the tissue. The imaging device (2610) can be located a predetermined distance from the opening of the suction tip (2606) to provide a buffer or gap between the tissue pulled into the opening of the suction tip (2606). The imaging device (2610) can include power and data conductors (e.g., electrical connectors, leads) extending from the imaging device (2610) through the vacuum tube (2604) and into the handle. The lumen of the vacuum tube (2604) can be sized sufficiently to hold the imaging device (2610) and still transmit the vacuum force through the vacuum tube (2610). In some variations, the suction tip (2606) can include as described with respect to Fig. 20 , 25A -25C and shapes such as those described in 33A-34C.

[0150] The closure device (2600) may further include a fastener (2620) configured to slidably retain portions of the elongated body (2602) and the vacuum tube (2604) relative to each other. The fastener (2620) may include a first body portion (2622) and a second body portion (2624) configured to be coupled to the elongated body (2602) and the vacuum tube (2604), respectively. Figures 26A-26B As shown, the first body portion (2622) can include a D-shaped body defining a corresponding D-shaped lumen that mimics or corresponds to the D-shape of the elongated body (2602) on which it is seated. Similarly, the second body portion (2624) can include a circular body defining a corresponding circular lumen that is configured to slide over the circular vacuum tube (2604).

[0151] The fastener (2620) can be coupled to a control wire (2628) (e.g., a pull wire), which can be coupled to a handle (not shown) at a proximal end and to one or more of the main body portions (2622, 2624) of the fastener (2620) at a distal end. The control wire (2628) can be advanced and retracted to slidably position the fastener (2620) along the length of the closure device (2600) (e.g., the elongated body (2602)). The control wire (2628) can be fixed to the fastener (2620) and can extend through a lumen of the elongated body (2602) (e.g., the same as or separate from the lumen of the snare loop assembly and the vacuum tube) and into the handle. In some variations, an operator can advance or retract the control wire (2682) relative to the elongated body (2602), thereby slidably positioning the fastener (2620) along the length of the closure device (2600). For example, control wire (2628) may extend from the proximal end of the handle, or may be coupled to an actuator (eg, a slider, knob, button, switch, etc.) of the handle. In some variations, vacuum tube (2604) and fastener (2620) may be independently movable.

[0152] In some variations, a mating assembly can be used to lock the aspiration tip (2606) to the fastener (2620). For example, the aspiration tip (2606) can include a first mating feature (2608) (e.g., a male connector) that is configured to engage a second mating feature (2626) (e.g., a female connector) of the fastener (2620). Fig.26B For example, the first mating feature (2608) may include a protrusion extending from the proximal end of the aspiration tip (2606), which may be configured to fit within a recess in the second fastener (2624).

[0153] In some variations, the fastener (2620) can be a sliding restraint attached to the distal portion of the elongated body (2602) and the vacuum tube (2604). The first and second body portions (2622, 2626) of the fastener (2620) can include a diameter sufficient to allow the fastener (2620) to slide along the length of the closure device (2620) (e.g., the elongated body (2602)). The fastener (2620) can be secured relative to the aspiration tip (2606) of the vacuum tube (2604) using a mating assembly (2608, 2626) on the aspiration tip (2606) and the fastener (2620). When mated, a consistent orientation can be maintained between the elongated body (2602) and the vacuum tube (2604) even as the distal portion of the closure device (2600) is manipulated within the patient's pericardial space.

[0154] As described above, the aspiration tip of the vacuum tube may include an atraumatic element that can physically engage tissue and hold the tissue adjacent to or within the vacuum tube without damaging the tissue. Figure 8 A variation of a vacuum tube (800) in use is depicted. As shown, the suction tip (802) of the vacuum tube (800) is coupled to cardiac tissue (810) containing a left atrial appendage (820). Typically, the middle portion (801) and the suction tip (802) of the vacuum tube (800) can advance on the front surface of the heart in a direction generally from bottom to top. Specifically, the suction tip (802) of the vacuum tube (800) advances on the left atrial appendage (820) tissue so that a portion of the left atrial appendage tissue (822) is placed in the lumen (804) of the suction tip (802) of the vacuum tube (800) (e.g., the tissue (822) contacts the opening of the lumen (804)). In some variations, the suction tip (802) of the vacuum tube (800) can first contact the apex of the left atrial appendage (820). When the heart tissue (822) blocks the opening of the lumen (804) of the suction tip (802) of the vacuum tube (800), the soft left atrial appendage (820) can be compressed together. In order for the vacuum tube (800) to position and stabilize the left atrial appendage (820) in the desired position, the lumen (804) of the suction tip (802) of the vacuum tube (800) must be substantially blocked by the left atrial appendage tissue (822) to form a vacuum seal. Once blocked, the pressure within the lumen (804) of the suction tip (802) of the vacuum tube (800) can be reduced by applying negative pressure (e.g., turning on the vacuum) to quickly draw the tissue (822) further into the lumen (804) of the suction tip (802).

[0155] like Figures 9A-9B As further depicted in FIGS. 10A-10B , the configuration of the aspiration tip of the vacuum tube can determine the amount of tissue that is aspirated into the aspiration tip. Fig.9A is a schematic side view of an illustrative variation of a vacuum tube (900) and a left atrial appendage (920). As shown, the vacuum tube (900) can include an aspiration tip (902) having an opening having a diameter / height (904) greater than the height (922) of the left atrial appendage (920). Fig. 9B yes Fig.9A A perspective view of a vacuum tube (900) coupled to a left atrial appendage (920) is depicted in FIG. Figures 9A-9B The round suction tip opening of the vacuum tube is shown.

[0156] Fig. 10A is a schematic side view of an illustrative variation of a vacuum tube (1000) and a left atrial appendage (1020). Fig. 10B yes Fig. 10AA perspective view of a vacuum tube (1000) coupled to a left atrial appendage (1020) using vacuum is depicted in FIG. Figures 10A-10B The oblong suction tip opening of the suction tip (1002) of the vacuum tube (1000) is shown having a height that is less than the diameter (904) of the circular suction tip opening of the suction tip (902) of the vacuum tube (900). Due to the diameter / height difference between the suction tip (902) of the vacuum tube (900) and the left atrial appendage (920), the lumen of the suction tip (902) has a larger volume to be filled with the left atrial appendage before a vacuum seal is formed by negative pressure. In contrast, a suction tip (1002) of the vacuum tube (1000) having a height substantially equal to the height of the cardiac tissue (1004) can result in less tissue bunching in the suction tip (1002) of the vacuum tube (1000). For example, Fig. 9B Shows the ratio Fig. 10B A larger amount of cardiac tissue is gathered into a ball and sucked into the suction tip (902) of the vacuum tube (900). The suction tip (1002) of the vacuum tube (1000) including an opening with a height approximately equal to the height of the left atrial appendage (1020) can assist in establishing a vacuum seal and can reduce potential damage to the left atrial appendage. For example, the height of the suction tip (1002) is advantageously matched to the generally flat and / or wide shape of the left atrial appendage (1020) to cover the suction tip (1002) to establish a vacuum. If the height of the suction tip of the vacuum tube is significantly greater than the height of the left atrial appendage, when the suction tip of the vacuum tube contacts the left atrial appendage, a gap is formed between the suction tip of the vacuum tube and the left atrial appendage, thereby inhibiting the vacuum seal. The vacuum suction force that holds the suction tip of the vacuum tube onto the cardiac tissue is proportional to the area of ​​the distal opening of the vacuum tube. Therefore, the holding force of the vacuum tube can be increased by increasing the width of the suction tip opening of the vacuum tube.

[0157] In some variations, the closure device described herein may include a vacuum tube configured to stabilize the closure device relative to the myocardial tissue surrounding the left atrial appendage (as opposed to stabilizing the closure device using a vacuum tube that draws suction to the left atrial appendage itself). The vacuum tube can assist in the stabilization of the closure device to help the closure element advance to ligate the tissue. For example, the vacuum tube can be advanced toward the myocardial tissue near the left atrial appendage, and a vacuum (e.g., negative pressure) can be applied to the myocardial tissue in contact with the vacuum tube to temporarily maintain the closure device in an appropriate position relative to the myocardium. That is, the vacuum tube can anchor the closure device to the heart. Typically, myocardial tissue is stronger than the fragile left atrial appendage, so that stronger suction can be applied to the myocardium than to the left atrial appendage. In some variations, this can allow additional stability and allow for a stronger coupling between the closure device and the cardiac tissue while minimizing the risk of damage to the left atrial appendage. In some variations, the vacuum tube can be anchored near (but not on) the left atrial appendage so that a snare ring assembly disposed within or extending from the elongated body can be more easily advanced (e.g., guided) around target tissue (e.g., the left atrial appendage).

[0158] like Fig.23A As shown, the vacuum tube (2304) can be slidably positioned within the lumen of the sheath (2302). As described herein, the closure device (2300) can be advanced toward the patient's heart (2310) using an epicardial approach, and in particular, toward the myocardial tissue (2312) and / or the left atrial appendage (2314). The vacuum tube (2304) can be slidably positioned within the lumen of the sheath (2302). For example, the vacuum tube (2304) can be sized to fit within the lumen of the sheath (2302). Additionally or alternatively, the vacuum tube (2304) can slide adjacent to the outer surface of the sheath (2302). The vacuum tube (2304) can include, as described with respect to Figures 23B-24D A vacuum (e.g., suction, negative pressure) may be applied to myocardial tissue (2312) in contact with the vacuum tube (2304) to temporarily hold the myocardium (2312) in place relative to the sheath (2302). In other words, the vacuum tube (2304) may anchor the sheath (2302) (and any other devices extending from the sheath) to the heart (2310).

[0159] The vacuum tube (2304) may be advanced out of the lumen of the sheath (2304) and may be expandable such that it may transition from a first configuration (e.g., a collapsed configuration, a delivery configuration) to a second configuration (e.g., an expanded configuration, a deployed configuration). In the second configuration, the vacuum tube (2304) may include a suction tip configured to apply a vacuum suction force to tissue in contact with the suction tip. In some variations, such as Figures 23B-23DAs shown, the vacuum tube (2304) may include one or more elongated members (2305, 2306), each of which defines a lumen passing through each of the elongated members. In some variations, the elongated members (2305, 2306) including a lumen and one or more holes may be placed on either side of the left atrial appendage (2314) (e.g., placed on the left and right sides of the apex of the left atrial appendage). For example, the elongated members (2305, 2306) may extend laterally from the longitudinal axis of the distal end of the sheath (2302). When the snare ring assembly is used to manipulate tissue (e.g., ligating the left atrial appendage (2314)), this placement of the vacuum tube (2304) may increase the stability of the closure device (2300) relative to the left atrial appendage (2314). In some variations, the intersection of the elongated members (2305, 2306) may form an angle between about 30 degrees and about 150 degrees relative to each other. In some variations, the intersection of elongated members (2305, 2306) may form an angle between about 80 degrees and about 130 degrees.In some variations, fluoroscopy and CT image data may be used to guide the placement of vacuum tube (2304).

[0160] like Fig. 23B As shown, the distal portion of the first slender member (2305) and / or the second slender member (2306) may include a spiral shape, and may each include one or more spaced-apart side holes and / or radial holes (e.g., openings) (not shown) disposed along a portion configured to contact the myocardium (e.g., along the spiral of the slender member). For example, the holes may be defined in the side walls of the slender members (2305, 2306). The spiral shape of the slender members (2305, 2306) may allow a large surface area of ​​the myocardium (2312) to be suctioned, so that a stronger coupling force may be formed between the closure device (2300) and the myocardium (2312). In some embodiments, the slender members (2305, 2306) may be formed into a shape other than a spiral, such as a circle, a triangle, a V-shape, a C-shape, a P-shape, a Y-shape, etc. For example, Fig.23D Depicted are variations of first and second elongated members (2320, 2321) comprising curved suction tips configured to contact myocardium (2312) at the distal ends of the elongated members (2320, 2321). For example, a vacuum may be applied to myocardium (2312) through a single distal hole of the first and second elongated members (2320, 2321). In some variations, one or more of the elongated members may be between about 2 cm and about 30 cm in length.

[0161] In some variations, a hole (not shown) may be defined on one side of the elongated member (2305, 2306) that is configured to be directly opposite (e.g., facing) the myocardium (2312). A vacuum force may be applied to the myocardial tissue through one or more holes in one or more of the elongated members (2305, 2306) to anchor the closure device (2300) to the myocardium (2312). The hole may have any suitable pattern and shape, such as circular, oval, polygonal, rectangular (e.g., slit), cross, combinations thereof, and the like. The size and / or shape of the hole may vary along the length of the elongated member (2305, 2306). For example, the distal hole may define a larger opening than the proximal hole. One or more of the elongated members may include any suitable number of holes, such as one, two, three, four, five, six, seven, eight or more, and the hole may be located at any suitable position along the length of one or more of the elongated members. In some variations, the elongated member may include between two and four holes, and in other variations, between three and five holes. For example, the number, size (e.g., surface area), and location of the holes may be based on the suction power generated by the vacuum pump. For example, a surface area of ​​about .06 in 2 The hole can be used with a vacuum pump as described herein to generate a negative pressure of about 560 mmHG, which can generate a tissue retention force of about 0.65 lbf.

[0162] In some variants, such as Fig.23C As shown, the elongated body (2307) can be configured to slide adjacent to the vacuum tube (2304) and within the lumen of the sheath (2302) so that the elongated body (2307) can be advanced and retracted relative to the vacuum tube (2304), or vice versa. For example, the vacuum tube (2304) can be configured to slide adjacent to the elongated body (2307) (and within the lumen of the sheath (2302)) or fit within the lumen of the elongated body (2307). The elongated members (2305, 2306) of the vacuum tube (2304) can extend beyond corresponding holes in the elongated body (2307) at a predetermined angle relative to the longitudinal axis of the elongated body (2307). The elongated body (2307) can include a snare ring assembly (2308) and an imaging device (not shown) as described herein. The elongated body (2307) and snare loop assembly (2308) may be configured to extend beyond the sheath (2302) and advance toward and / or over the left atrial appendage (2314) as described herein to perform left atrial appendage (2314) capture and / or ligation.

[0163] Additionally or alternatively, the vacuum tube may include a cardiac electrophysiology diagnostic device configured to receive electrophysiological data (e.g., electrocardiogram signals) from cardiac tissue (e.g., myocardium, pericardium, left atrial appendage). For example, the vacuum tube may include one or more electrodes and may be configured to receive / measure electrical signals from the tissue. For example, the one or more electrodes may be positioned at Figures 23A-24D Between and / or adjacent to the holes shown. The signal data received from the electrodes can be used to determine which parts of the vacuum tube (2402) are in contact with the tissue, and which tissues the vacuum tube (2402) is in contact with. The signal data can be received and processed by a controller including a processor and a memory. In some variations, unless the signal data from one or more electrodes indicates contact between the vacuum tube and the tissue, suction can be suppressed. Alternatively, based on which electrodes (if any) are measuring electrical signals, the suction force provided to the holes in different parts of the vacuum tube / suction tip or the suction force provided at the holes can be different. For example, an electrode placed on the distal portion of the vacuum tube can receive an electrical signal corresponding to tissue contact. Furthermore, the suction force of one or more holes in the distal portion of the vacuum tube (e.g., near, on either side of, or adjacent to an electrode receiving an electrical signal indicating tissue contact) can be increased so that suction is effectively applied. Conversely, the suction force of holes adjacent to electrodes that do not receive electrical signals from tissue can be reduced.

[0164] The force applied to the tissue by the vacuum tube can assist in properly positioning and stabilizing the closure device to ligate the tissue. Thus, the closure device described herein can ligate tissue without the need for a separate positioning device and / or stabilizing device, such as a balloon, wire, magnet, etc. In a variant in which the closure device is used to close the left atrial appendage, closure can be achieved from the pericardial space using only a single entry point to percutaneously enter the outer surface of the left atrial appendage. Thus, there is no need for components such as balloons, wires, and / or magnets that pass through the atria or otherwise advance within the left atrial appendage. In this way, epicardial, single entry site (e.g., subxiphoid) surgery is sufficient to ligate the left atrial appendage using the closure device described herein, which can make left atrial appendage surgery simpler, less expensive, and safer.

[0165] In some variations, one or more of the vacuum tube (e.g., the suction tip of the vacuum tube), the elongated member, the elongated body, and the sheath may also include markings that can provide an indication of the position of the closure device in the body and the advancement of the closure device. The markings may include any suitable markings, such as visual, radiopaque, or echogenic markings, and may be attached to the elongated body and / or the vacuum tube in any suitable manner (e.g., printed thereon, adhesive, ring, etc.). One or more of the elongated body and the vacuum tube may include any suitable number of markings, such as one, two, three, four, or more, and the markings may be located at any suitable position along the length of one or more of the elongated body, the vacuum tube, and other tubes (e.g., an imaging tube as described in more detail below).

[0166] In some variations, the vacuum tube may include an echogenic surface that may assist in visualizing the position of the vacuum tube within the body. Fig.11A is a side view of a vacuum tube (1100) comprising an aspiration tip (1102) having a first echogenic surface (1104). The aspiration tip (1102) of the vacuum tube (1100) can be visualized under transesophageal echocardiography (TEE) and / or fluoroscopy to provide location and positioning information of the closure device within the body. Thus, the echogenic aspiration tip (1102) of the vacuum tube (1100) can facilitate indirect visualization of the portion of the vacuum tube (1100) that contacts tissue (e.g., the left atrial appendage). The aspiration tip (1102) can include any echogenic surface texture. For example, Fig.11A A first echogenic surface (1104) comprising a spiral groove pattern is shown. Fig. 11B depicts a second echogenic surface (1106) comprising a circular dimple pattern, and Fig. 11C A third echogenic surface (1108) comprising a diamond-shaped dimple pattern is depicted. It should be understood that the echogenic surface may include one or more geometric shapes, written characters, and repeating patterns thereof. The echogenic surface may include one or more protrusions and depressions that may be distinguished for indirect visualization. In some variations, the depressions and protrusions may include one or more lines and line intersections that form an identifiable image contrast.

[0167] In some variations, the closure device described herein may include an elongated body, a vacuum tube having an echogenic suction tip, and an imaging device disposed in the suction tip of the vacuum tube. The imaging device may directly visualize tissue from the lumen of the vacuum tube. The echogenic suction tip of the vacuum tube may be indirectly visualized to assist in orienting and positioning the vacuum tube relative to the main body structure. The advancement, stabilization, and closure procedures described herein may be performed using one or more direct and indirect visualization techniques. In some variations, the vacuum tube may include a port and / or lumen configured to form a saline bubble from the suction tip of the vacuum tube to assist in visualization of the suction tip of the vacuum tube using TEE.

[0168] In other variations, the closure device may include a vacuum tube having an echogenic suction tip, and one or more imaging devices disposed in the suction tip of the vacuum tube and slidably adjacent to the vacuum tube and the elongated body (as described in further detail below). It should be understood that the vacuum tube having an echogenic suction tip may be provided without an imaging device disposed in the vacuum tube, or the vacuum tube may be used without another imaging modality, thereby reducing the number of elements in the imaging device and the number of steps in the closure procedure. The echogenic surface patterns shown and described above may be applied to any surface of the closure device, such as the outer surface of the vacuum tube and / or the elongated body. The vacuum tube and the elongated body may have different surface patterns to help distinguish the closure device elements.

[0169] The vacuum tubes described herein can include any suitable length, and the length of the vacuum tube can vary depending on the type of procedure being performed. The vacuum tube can be made of any suitable material, such as one or more polymers (e.g., reinforced polyetheramide, polyimide, polyurethane, etc.). The vacuum tube can be braided, non-braided, tapered, non-tapered, or some combination thereof. In some variations, the cross-sectional shape of the vacuum tube can vary along its length, but this is not required. Figure 6 As shown, the middle portion (602) of the vacuum tube (600) can include polyimide and stainless steel wire braid. In some variations, the outer diameter of the vacuum tube can be between about 0.10 cm and 0.30 cm. In some cases, the outer diameter of the vacuum tube can be about 0.203 cm.

[0170] Contrast tube

[0171] The closure device described herein may also include a contrast tube that can be used to facilitate advancement and placement of the closure device relative to the target tissue. The contrast tube can assist in one or more of: 1) visualization and / or identification of tissue structures (e.g., for proper placement of the vacuum tube relative to the target tissue in order to guide the closure element); 2) confirmation that a vacuum is applied to the target tissue to assist in advancing the closure element around the tissue; 3) visualization and / or confirmation of the closure position; and 4) confirmation of tissue closure. For example, contrast fluid can be injected through the contrast tube during one or more steps of a tissue closure procedure (e.g., a left atrial appendage closure procedure) to visualize tissue structures and / or confirm that a vacuum is applied to tissue in contact with the vacuum tube. In some variations, the injection tip of the contrast tube can be positioned proximal to the aspiration tip of the vacuum tube so that contrast fluid can be injected near the aspiration tip to assist in visualization of tissue structures adjacent to the aspiration tip. In this manner, closure devices and closure elements directed to the left atrial appendage can be appropriately positioned to achieve tissue closure, and the closure can be confirmed without a separate device and / or injection of a reduced volume of contrast fluid, thereby increasing the safety and reducing the complexity of the closure procedure. In some cases, the contrast tubes and / or vacuum tubes described herein can form or otherwise become part of a tissue stabilization device that can be used separately from or in conjunction with a tissue closure device.

[0172] The contrast tube or tissue stabilization device can be configured to be slidably positioned relative to the elongated body of the closure device, so that the contrast tube or tissue stabilization device can be advanced and retracted relative to the elongated body of the closure device, and vice versa. In some variations, the contrast tube and the vacuum tube can be integrally formed and parallel to each other (e.g., can include parallel lumens). For example, in some variations, the device described herein can include a multi-lumen (e.g., double-lumen) elongated body, wherein the first lumen can be configured to apply a vacuum, and the second lumen can be configured to inject a contrast agent. In other variations, the contrast tube and the vacuum tube can each include an elongated body having a lumen passing through the contrast tube and the vacuum tube, and the contrast tube and the vacuum tube can be attached during assembly using any suitable means, including welding, adhesives, connectors, combinations thereof, etc. As another example, the contrast tube and the vacuum tube can remain separate components, and the contrast tube and the vacuum tube can each be configured to fit within the lumen of the elongated body to slide within or adjacent to the elongated body.

[0173] Fig.40A and 40B 4 and 5 are side and cross-sectional side views, respectively, of an illustrative variation of a closure device (4000) comprising an aspiration tip (4010), an injection tip (4020), and an elongated body or tube (4030) comprising a Figures 41A-41BThe vacuum tube (4122) and contrast tube (4132) are shown. The proximal end of the tube (4030) can be coupled to a fluid connector (4040) including a first Y-shaped arm and a vacuum connector (4042) including a second Y-shaped arm. In some variations, the fluid connector (4040) can be used to couple the proximal end of the tube (4030) to a fluid (e.g., contrast fluid, radiocontrast agent, contrast dye) source (e.g., an injector). In some variations, the vacuum connector (4042) can be used to couple the proximal end of the vacuum tube to a vacuum source (e.g., an electronic or mechanical vacuum pump, a wall outlet of a central vacuum system). In some variations, the closure device (4000) can include one or more electrodes ( Figures 40A-40B 4000). The closure device (4000) may include power and data conductors (4012) of the elongated body or tube (4030), which may extend through the tube (4030), the fluid connector (4040), and the vacuum connector (4042). The conductor (4012) may be coupled to a cardiac electrophysiology diagnostic device configured to receive electrophysiological data (e.g., electrocardiogram signals) of cardiac tissue (e.g., myocardium, pericardium, left atrial appendage). The electrophysiology diagnostic device may process and / or output data (e.g., display images) for use during surgery. The signal data received from the one or more electrodes may be used to determine aspiration of the closure device (4000) by the tissue. Although not shown, the closure device (4000) may include a handle coupled to the proximal end of the elongated body or tube (4030), and in some variations coupled to the vacuum tube and / or the angiography tube. The handle may be fluidly coupled to the vacuum tube and the angiography tube, and may include one or more of a tube control, an angiography fluid control, and a vacuum control. For example, the contrast fluid control can be configured to use an actuator (eg, a slider, knob, button, switch, combinations thereof, etc.) to control the frequency and duration of contrast media injection.

[0174] Fig.41A is a cross-sectional side view of an illustrative variation of closure device (4100), and Fig.41Bis a cross-sectional view of an illustrative variation of the closure device. The closure device (4100) may include an elongated body or tube (4110) including a vacuum tube (4122) and a contrast tube (4132). The vacuum tube (4122) may define a circular vacuum lumen (4124), and the contrast tube (4132) may define a crescent-shaped contrast fluid lumen (4134). Thus, the elongated body (4110) may include a vacuum lumen (4124) and a contrast fluid lumen (4134). The distal end of the vacuum tube (4122) may be coupled to the suction tip (4120), and the distal end of the contrast tube (4132) may be coupled to the injection tip (4130). The vacuum lumen (4124) may be in fluid communication with the suction tip (4120), and the contrast fluid lumen (4134) may be in fluid communication with the injection tip (4130). When the proximal end of the vacuum lumen (4124) is coupled to a vacuum source, the vacuum lumen (4124) can have any configuration sufficient to provide negative pressure at the aspiration tip (4120), and when the proximal end of the contrast fluid lumen (4134) is coupled to a fluid source, the contrast fluid lumen (4134) can have any configuration sufficient to provide contrast fluid at the injection tip (4130).

[0175] The outer diameter of the suction tip (4120) and the injection tip (4130) can each be larger than the outer diameter of the elongated body or tube (4110). The size and shape of the suction tip (4120) and the injection tip (4130) can be set to be trauma-proof so that when releasably coupled to the tissue, the suction tip and the injection tip will not tear, pierce or otherwise damage the tissue. The suction tip (4120) and the vacuum tube (4122) can include any configuration described in more detail herein. When negative pressure / suction force is applied by the vacuum tube (4122), the size of the suction tip (4120) can be set to receive the tissue and keep the tissue in place. The injection tip (4130) can be placed near the suction tip (4120). For example, the proximal end of the suction tip (4120) can be close to the distal end of the injection tip (4130). The distal end of the vacuum tube lumen (4124) can be placed in the injection tip (4130). like Fig.41A As shown, the injection tip (4130) can be parallel and concentric with respect to the vacuum tube (4122). That is, at least a portion of the suction tip (4120) can be nested in the injection tip (4130). The distal end of the injection tip (4130) and at least the proximal end of the suction tip (4120) can define an annular hole (4131). In some variations, the area of ​​the annular hole (4131) can be about 0.048in 2 or at least about 0.048in 2The injection tip (4130) may be located a predetermined distance from the distal end of the aspiration tip (4120) of the vacuum tube (4122) to provide a buffer between tissue (e.g., cardiac tissue) drawn into the opening of the aspiration tip (4120) and any contrast fluid injected from the distal end of the injection tip (4130).

[0176] Using something similar to Fig.41A The continuous annular opening of the aperture depicted in the can advantageously direct contrast fluid along or near the outer surface of the injection tip (4130), which can allow a user to better visualize tissue around or near the injection tip (4130). The use of a continuous annular opening can also prevent contrast fluid from being ejected from the injection tip (4130) or otherwise rapidly dispersed radially outward from the injection tip. Thus, in some variations, the use of a continuous annular opening can allow a user to better locate and / or confirm the shape of the target tissue, confirm attachment to the target tissue, and / or confirm closure of the target tissue.

[0177] The suction tip (4120) and the injection tip (4130) may include a conical, cup-shaped or other concave configuration. These configurations may allow the injection tip (4130) to concentrically inject contrast fluid around the suction tip (4120) to evenly distribute the contrast fluid in the body cavity. The outer surface of the distal end of the suction tip (4120) may be angled relative to the longitudinal axis of the closure device (4100). This may allow the fluid injected from the opening of the injection tip (4130) to be guided in the distal direction. In some variations, one or more portions of the injection tip (4130) and / or the tube (4110) may include a mark that may provide an indication of the position of the closure device in the body and / or the advancement of the closure device. The mark may be any suitable mark, such as a visual, radiopaque or echogenic mark, and may be attached to the injection tip (4130) and / or the tube (4110) in any suitable manner (e.g., printed thereon, adhesive, ring, combination thereof, etc.). For example, the injection tip (4130) may include an echogenic surface as described in more detail herein. The closure device may include any suitable number of markings, such as one, two, three, four, or more, and the markings may be located at any suitable position along the length of one or more of the injection tip (4130), the aspiration tip (4120), and the tube (4110).

[0178] Although the aspiration tip (4120) and the injection tip (4130) are Fig.41A10 is shown as having an outer diameter of approximately equal diameter, but the outer diameter of the injection tip (4130) can be greater than the outer diameter of the aspiration tip (4120) so that the annular hole (4131) of the injection tip (4130) can extend on the aspiration tip (4120) to the distal end of the aspiration tip (4120). At least a portion of the tube (4110) can be slidably disposed within the lumen of the elongated body (402). Additionally or alternatively, the injection tip (4130) can include one or more radial holes (not shown) on the side of the injection tip (4130).

[0179] In some variations, one or more electrodes (4142) may be disposed within the suction tip (4120) as described in more detail herein. The electrode (4142) may be located a predetermined distance from the opening of the suction tip (4120) (e.g., may be set back from the opening) to provide a buffer or gap between the tissue drawn into the opening of the suction tip (4120). The electrode (4142) may be coupled to a power and data conductor (4144) (e.g., an electrical connector, a lead) that may extend through the vacuum lumen (4124). The power and data conductor (4144) may be insulated. In other variations, the suction tip (4120) may not include an electrode.

[0180] In some variations, the angiography tube (4132) can be configured to be slidably positioned relative to the vacuum tube (4120). For example, the injection tip (4130) can be advanced toward the aspiration tip (4120) and retracted proximally relative to the vacuum tube (4122) and the aspiration tip (4120). A fastener (not shown) can slidably couple the distal end of the angiography tube (4132) to the vacuum tube (4122) or slidably couple the injection tip (4130) to the elongated body or tube (4110). This can help ensure that the vacuum tube (4122) and the angiography tube (4132) and / or the aspiration tip (4120) and the injection tip (4130) are aimed in the same direction and can assist in positioning the tubes and / or tips relative to each other.

[0181] Fig.42A and 42B4 is a perspective view of an illustrative variation of a closure device (4200) comprising an aspiration tip (4220), a contrast fluid tube (4210), and a vacuum tube (4212). The vacuum tube (4212) can define a circular vacuum lumen (4230), and the contrast fluid tube (4210) can define an annular contrast fluid lumen (4228) that can be concentric and coaxial with the vacuum tube (4212). That is, at least a portion of the vacuum tube (4212) can be nested in the contrast fluid tube (4210). The distal end of the vacuum tube (4212) can be coupled to the aspiration tip (4220), and the distal end of the contrast tube (4210) can be coupled to a plurality of (e.g., two, three, four, five, or more) injection channels (4226) defined by the length of the wall of the aspiration tip (4220). Each of the injection channels (4226) can be coupled to a corresponding injection hole (4224). A plurality (e.g., two, three, four, five, or more) of injection holes (4224) can be disposed on the outer surface of the suction tip (4220) at the distal end of the suction tip (4220). In some variations, a plurality of injection holes (4224) can be disposed along the length of the injection channel (4226). The vacuum tube (4212) can define a vacuum lumen (4232) that can have any configuration sufficient to provide negative pressure at the suction tip (4220) when the proximal end of the vacuum lumen (4232) is coupled to a vacuum source.

[0182] like Fig.42C As shown, the outer diameter of the suction tip (4220) can be greater than the outer diameter of the vacuum tube (4212) or the contrast fluid tube (4210). The size and shape of the suction tip (4220) can be set to be trauma-proof so that when releasably coupled to the tissue, the suction tip does not tear, puncture or otherwise damage the tissue. The suction tip (4220) can include any configuration described in more detail herein. When negative pressure / suction force is applied through the vacuum tube (4212), the size of the suction tip (4120) can be set to receive the tissue and keep the tissue in place. The injection hole (4224) can be arranged at a predetermined distance proximal to the suction hole (4230) to provide a buffer between the tissue (e.g., cardiac tissue) drawn into the suction hole (4230) of the suction tip (4220) and any contrast fluid injected from the injection hole (4224).

[0183] The suction tip (4220) may include a conical, cup-shaped or other concave configuration. The injection hole (4224) may be configured to concentrically inject contrast fluid around the suction tip (4220) to evenly distribute the contrast fluid in the body cavity. In some variations, one or more portions of the closure device (4200) may include a mark that can provide an indication of the position of the closure device (4200) in the body and / or the advancement of the closure device. The mark can be any suitable mark, such as a visual, radiopaque or echogenic mark, and can be attached to the suction tip (4220) and / or tube (4210) in any suitable manner (e.g., printed thereon, adhesive, ring, combination thereof, etc.). For example, the suction tip (4220) may include an echogenic surface as described in more detail herein. The closure device may include any suitable number of marks (e.g., one, two, three, four or more), and the mark may be located at any suitable location. The suction tip (4220) may include any features of the suction tip described herein. As a non-limiting example, the suction tip (4220) may include information regarding Figures 48A-48C Features described by the suction tip (4620) depicted in .

[0184] In some variations, one or more electrodes (not shown) may be disposed within the suction tip (4220) as described in more detail herein. The electrodes may be located a predetermined distance from the opening of the suction tip (4220) to provide a buffer or gap between the tissue drawn into the opening of the suction tip (4220). The electrodes may be coupled to power and data conductors (not shown) (e.g., electrical connectors, leads) that may extend through the vacuum lumen (4232). The power and data conductors may be insulated. In other variations, the suction tip (4220) may not include electrodes.

[0185] Fig.44A and 44B 4400, the closure device includes an aspiration tip (4410), an injection port (4420), and an elongated body or tube (4430) including a Figures 45A-45B The vacuum tube (4522) and contrast tube (4532) are shown. Thus, the elongated body or tube (4430) can include a vacuum lumen (4524) and a contrast fluid lumen (4534). The proximal end of the tube (4430) can be coupled to a fluid connector (4440) including a Y-shaped arm. In some variations, the fluid connector (4440) can be used to couple the proximal end of the tube (4430) to a source (e.g., an injector) of a fluid (e.g., a contrast fluid, a radiocontrast agent, a contrast dye). Similar to Figures 40A-40BIn the closure device (4000), the closure device (4400) may include a plurality of Y-shaped arms including a vacuum connector as described herein. In some variations, the closure device (4400) may include a power and data conductor (4412) coupled to one or more electrodes within the suction tip (4410) and extending through the tube (4430) and the fluid connector (4440) to couple to a cardiac electrophysiology diagnostic device (not shown), the cardiac electrophysiology diagnostic device being configured to receive electrophysiological data (e.g., electrocardiogram signals) of cardiac tissue (e.g., myocardium, pericardium, left atrial appendage). The electrophysiology diagnostic device may process and / or output data (e.g., display images) for use during surgery. The signal data received from the one or more electrodes may be used to determine the suction of the closure device (4400) by the tissue. Although not shown, the closure device (4400) may include a handle coupled to the proximal end of the tube (4430) (e.g., vacuum tube, angiography tube). The handle may include one or more of a tube control, a contrast fluid control, and a vacuum control. For example, the contrast fluid control may be configured to control the frequency and duration of contrast agent injection using an actuator (e.g., a slider, a knob, a button, a switch, a combination thereof, etc.).

[0186] Fig.45A is a side view of an illustrative variation of a closure device (4500), Fig.45B is a cross-sectional side view of an illustrative variation of the closure device, and Fig.45C is a cross-sectional front view of an illustrative variation of the closure device. The closure device (4500) may include an elongated body or tube (4510) including a vacuum tube (4522) and a contrast tube (4532). The vacuum tube (4522) may define a circular vacuum lumen (4524), and the contrast tube (4532) may define a circular contrast fluid lumen (4534). The contrast tube (4532) may be coaxial and concentric with the vacuum tube (4522). The distal end of the vacuum tube (4522) may be coupled to the aspiration tip (4520), and the distal end of the contrast tube (4532) may be coupled to the injection tip (4530). When the proximal end of the vacuum lumen (4524) is coupled to a vacuum source, the vacuum lumen (4524) can have any configuration sufficient to provide negative pressure at the aspiration tip (4520), and when the proximal end of the contrast fluid lumen (4534) is coupled to a fluid source, the contrast fluid lumen (4534) can have any configuration sufficient to provide contrast fluid at the injection tip (4530).

[0187] The outer diameter of the suction tip (4520) and the injection tip (4530) can each be larger than the outer diameter of the tube (4510). The size and shape of the suction tip (4520) and the injection tip (4530) can be set to be trauma-proof so that when releasably coupled to tissue, the suction tip and the injection tip will not tear, puncture or otherwise damage the tissue. The suction tip (4520) and the vacuum tube (4522) can include any configuration described in more detail herein. When a negative suction force is applied through the vacuum tube (4522), the size of the suction tip (4520) can be set to receive tissue and hold the tissue in place. The injection tip (4530) can be positioned proximal to the suction tip (4520). For example, the proximal end of the suction tip (4520) can be close to the distal end of the injection tip (4530). The distal end of the vacuum tube lumen (4524) can be positioned within the injection tip (4530). Fig.45B As shown, the injection tip (4530) can be parallel and concentric with respect to the vacuum tube (4522). That is, at least a portion of the aspiration tip (4520) can be nested in the injection tip (4530). The distal end of the injection tip (4530) and at least the proximal end of the aspiration tip (4520) can define a plurality of radial holes (4536). The injection tip (4530) can be located at a predetermined distance from the distal end of the aspiration tip (4520) of the vacuum tube (4522) to provide a buffer between tissue (e.g., cardiac tissue) drawn into the opening of the aspiration tip (4520) and any contrast fluid injected from the distal end of the injection tip (4530).

[0188] The radial apertures (4536) can have any length and width suitable for injecting contrast fluid for visualization of target tissue. For example, in some variations, the length can be between about 0.060 inches and about 0.080 inches, and the width can be between about 0.030 inches and 0.080 inches. While a range of lengths and widths is possible, the use of larger radial apertures (4536) can advantageously guide contrast fluid along or near the outer surface of the injection tip (4530), and can prevent contrast fluid from being ejected radially outward from the injection tip (4530) or otherwise rapidly dispersed, or reduce the likelihood that contrast fluid will be ejected radially outward from the injection tip or otherwise rapidly dispersed. Thus, in some variations, the use of larger radial apertures, as described in more detail herein, can allow a user to better locate and / or confirm the shape of the target tissue, confirm attachment to the target tissue, and / or confirm closure of the target tissue.

[0189] The aspiration tip (4520) and the injection tip (4530) may include a conical, cup-shaped, or other concave configuration. These configurations may allow the injection tip (4530) to inject contrast fluid concentrically around the aspiration tip (4520) to evenly distribute the contrast fluid in the body cavity. Fig.45C As shown, the vacuum tube (4522) can be concentrically disposed within the contrast fluid tube (4532). The outer surface of the distal end of the suction tip (4520) can be angled relative to the longitudinal axis of the closure device (4500) to allow the fluid injected from the opening of the injection tip (4530) to be directed in the distal direction. In some variations, one or more portions of the injection tip (4530) and / or the tube (4510) may include a mark that can provide an indication of the position of the closure device in the body and / or the advancement of the closure device. The mark can be any suitable mark, such as a visual, radiopaque or echogenic mark, and can be attached to the injection tip (4530) and / or the tube (4510) in any suitable manner (e.g., printed thereon, adhesive, ring, combination thereof, etc.). For example, the injection tip (4530) may include an echogenic surface as described in more detail herein. The closure device may include any suitable number of markings, such as one, two, three, four, or more, and the markings may be located at any suitable position along the length of one or more of the injection tip (4530), the aspiration tip (4520), and the tube (4510).

[0190] In some variations, one or more electrodes (4542) may be disposed within the suction tip (4520) as described in more detail herein. The electrode (4542) may be located a predetermined distance from the opening of the suction tip (4520) to provide a buffer or gap between the tissue drawn into the opening of the suction tip (4520). The electrode (4542) may be coupled to a power and data conductor (4544) (e.g., an electrical connector, a lead) that may extend through the vacuum lumen (4524). The power and data conductor (4544) may be insulated. In other variations, the suction tip (4520) may not include an electrode.

[0191] Fig.46A and 46B Depicted are side and cross-sectional side views of another variation of a closure device (4600). Fig.46C Describes the formation Figures 46A-46B). The closure device (4600) may include an elongated body or tube (4610), an aspiration tip (4620) coupled to the elongated body (4610), and an injection tip (4630) coupled to the elongated body (4610) proximal to the aspiration tip (4620). In some variations, the closure device (4600) may also include a manifold (4639) coupled to the proximal end of the elongated body (4610).

[0192] The elongated body (4610) may include a vacuum tube (4622) and a contrast tube (4632), which may define a vacuum lumen (4624) and a contrast fluid lumen (4634), respectively. The vacuum tube (4622) and the contrast tube (4632) may be integrally formed, such that the elongated body (4610) may include or define a vacuum lumen (4624) and a contrast fluid lumen (4634). As may be seen in Fig.46D As seen in FIG. 4 , which depicts a cross-sectional front view of the elongated body (4610) of the closure device (4600), the vacuum lumen (4624) can have a crescent-shaped cross-sectional shape, and the contrast fluid lumen (4624) can have a circular cross-sectional shape. The aspiration tip (4620) and the injection tip (4630) can each be coupled to the distal end of the elongated body (4610) such that the vacuum lumen (4624) can be in fluid communication with the aspiration tip (4620), and the contrast fluid lumen (4634) can be in fluid communication with the injection tip (4630). When the proximal end of the vacuum lumen (4624) is coupled to a vacuum source, the vacuum lumen (4624) can have any configuration sufficient to provide negative pressure at the aspiration tip (4620), and when the proximal end of the contrast fluid lumen (4634) is coupled to the fluid source, the contrast fluid lumen (4634) can have any configuration sufficient to provide contrast fluid at the injection tip (4630). For example, in some variations, the diameter of the vacuum lumen (4624) can be between about 0.039 inches and 0.043 inches, between about 0.040 inches and 0.042 inches, between about 0.0410 inches and 0.0415 inches, or its diameter can be about 0.0415 inches. Additionally or alternatively, the cross-sectional area of ​​the contrast fluid lumen (4634) can be greater than or equal to 0.00125 in 2. In addition, although the contrast fluid lumen (4634) and the vacuum lumen (4624) are depicted as having crescent and circular cross-sectional shapes, respectively, they can have different cross-sectional shapes (other than crescent or circle, such as semicircular) and / or they can both have the same cross-sectional shape (e.g., both are circular, both are semicircular, both are crescent, etc.). The contrast fluid lumen (4634) and the vacuum lumen (4624) can have the same or different lengths. For example, in some variations, the contrast fluid lumen (4634) can be shorter than the vacuum lumen (4624), as will be described in more detail herein.

[0193] As described above, the proximal end of the elongated body (4610) may be coupled to the manifold (4639) (at Fig.46C ), the manifold may include a fluid connector (4640) and a vacuum connector (4642). The fluid connector (4640) may be used to couple the elongated body (4610) to a source of fluid (e.g., contrast fluid, radiocontrast agent, contrast dye, etc.) (e.g., an injector), and the vacuum connector (4642) may be used to couple the elongated body (4610) to a vacuum source (e.g., an electronic or mechanical vacuum pump, a wall outlet of a central vacuum system). The fluid connector (4640) may include a distal connector (4643) and a Y-arm (4641), and the distal connector (4643) may be configured to couple to the elongated body (4610) and the Y-arm (4641). The vacuum connector (4642) may include a Y-arm (4644) and a proximal connector (4646), the proximal connector being configured to couple to a vacuum source. In some variations, fluid connector (4640) and vacuum connector (4642) can be coupled to each other. Figures 46A-46CIn the illustrated variations, a distal connector (4643) can be coupled to the proximal end of the elongated body (4610), a branch of a fluid Y-arm (4641) can be coupled to a contrast fluid source, such as an injector (4645) containing contrast fluid, via a valve (4647), and the proximal end of the fluid Y-arm (4641) can be coupled to the distal end of a vacuum Y-arm (4644). In some variations, the valve (4647) can include a handle and can form a contrast fluid control, while in other variations, the valve (4647) can be coupled to a separate contrast fluid control or actuator (e.g., a slider, knob, button, switch, combination thereof, etc.). The branch of the vacuum Y-arm (4644) can be connected to a vacuum control (4649) (e.g., a slider, knob, button, switch, combination thereof, etc.), and the proximal connector (4646) can be coupled to a vacuum source (not depicted). The contrast fluid control and vacuum control may be configured to control the frequency and duration of contrast agent injection and aspiration, respectively.In some cases, manifold (4639) may act as a handle during use, while in other variations, manifold (4639) may be coupled to a handle.

[0194] In some variations, the closure device (4600) can be configured to generate negative pressure through the vacuum lumen (4624). For example, in some variations, the closure device (4600) can further include a vacuum source (e.g., a vacuum pump) that is fluidly coupled to the vacuum lumen (4624) and configured to provide suction at the distal end of the suction tip (4620) (e.g., at the suction hole). The vacuum source can be coupled to a vacuum connector (4642) (e.g., coupled to the proximal end of the proximal connector (4646)) and operably coupled to a vacuum control (4649). When using the vacuum source, the closure device (4600) can be configured to have a tissue retention force or attachment force to releasably couple the suction tip (4620) and, therefore, the closure device to the target tissue. In some variations, the tissue retention force can be between about 0.10 lbf and about 0.41 lbf, between about 0.10 lbf and about .33 lbf, between about 0.2 lbf and about 0.40 lbf, or about 0.33 lbf. In some cases, the vacuum pump can generate a negative pressure of about 400 mmHG, which can generate a tissue retention force of about 0.33 lbf.

[0195] In addition, the closure device (4600) can be configured to dispense contrast fluid. For example, in some variations, the closure device (4600) can further include a contrast fluid source coupled to the contrast fluid lumen (4634). The contrast fluid source can be coupled to a fluid connector (4640), such as a branch of a fluid Y-arm (4641), and can be operably coupled to a contrast fluid control (e.g., valve (4647)). The closure device (4600) can be configured to dispense between about 10cc and about 60cc of contrast fluid.

[0196] In some variations, the closure device (4600) may be configured to receive and transmit signals during surgery. For example, in some variations, the closure device (4600) may include one or more electrodes ( Figures 46A-46B ) and extending through the elongated body (4610), the fluid connector (4640), and the vacuum connector (4642). The conductors can be coupled to a cardiac electrophysiological diagnostic device that is configured to receive electrophysiological data (e.g., electrocardiogram signals) of cardiac tissue (e.g., myocardium, pericardium, left atrial appendage). The electrophysiological diagnostic device can process and / or output data (e.g., display images) for use during surgery. The signal data received from the one or more electrodes can be used to assist in tissue identification during surgery, such as which tissue is contacting the suction tip (4620). In these variations, the electrodes can have any of the configurations and / or features described above with respect to other closure device variations that include electrodes.

[0197] Figures 47A-47C Depicted Fig.46A and 46B, a front perspective view, a side view, and a front view of the injection tip (4630) of the closure device (4600) depicted in . The injection tip (4630) may include a cylindrical proximal portion (4702), a conical middle portion (4704), a cylindrical distal portion (4706), and a lumen (4710) therethrough. The cylindrical proximal portion (4702) may have a first diameter, and the cylindrical distal portion (4706) may include a second, larger diameter. In some variations, the first diameter may be between about 0.018 inches and 0.120 inches, or may be about 0.119 inches. The second diameter may be between about 0.253 inches and 0.257 inches, or may be about 0.255 inches. The lumen (4710) may also include a first diameter in the proximal portion (4702) and a second, larger diameter in the distal portion (4706). For example, in some variations, the first diameter of the lumen can be between about 0.087 inches and 0.091 inches, or can be about 0.089 inches. The second diameter of the lumen can be between about 0.219 inches and about 0.223 inches, or can be about 0.221 inches. The proximal portion (4702) and the lumen therethrough can be configured to receive the elongated body (4610), while the distal portion (4706) can be configured to transfer fluid from within the injection tip (4630) to the surrounding body cavity.

[0198] The cylindrical distal portion (4706) may have a plurality of injection holes or radial holes (4708) formed between the plurality of arms (4709). One or more of the plurality of arms (4709) may include a distal surface (4712) that is tapered or angled relative to the longitudinal axis of the injection tip (4630). For example, the distal surface (4712) of one or more of the plurality of arms (4709) may be angled or tapered toward the lumen (4710). The injection tip (4630) may have a proximal circumference and a proximal diameter in the proximal portion (4702), and a distal circumference and a distal diameter in the distal portion (4706). The distal circumference may be greater than the proximal circumference, and the distal diameter may be greater than the proximal diameter. In addition, both the proximal diameter and the distal diameter may be greater than the diameter of the elongated body (4610).

[0199] The injection tip (4630) can have any suitable number (e.g., two, three, four, five, or more) of injection holes (4708) and arms (4709), and the injection holes (4708) can have any shape suitable for the passage of contrast fluid therethrough. In some variations, the injection holes (4708) can have a generally rectangular cross-sectional shape, and specifically, can have an arched or curved rectangular shape. The injection holes (4708) can be circumferentially spaced in the distal portion (4706), and the circumference of the distal portion can be made discontinuous. In some cases, the injection holes (4708) can be evenly spaced around the circumference of the distal portion (4706). For example, in some variations, the injection holes (4708) can be spaced approximately 90 degrees center-to-center. In other variations, injection holes (4708) may be closer together, such as between about 75-85 degrees apart center-to-center, or farther apart, such as about 100-180 degrees apart, center-to-center.

[0200] The injection hole (4708) can be sized to facilitate transfer of contrast fluid from within the injection tip (4630) to the surrounding body cavity along or near the outer surface of the aspiration tip. For example, in some variations, the length (4714) of the injection hole (4708) can be between about 0.020 inches and about 0.110 inches, and the width (4716) can be between about 0.030 inches and about 0.080 inches. In some of these variations, the length (4714) of the injection hole (4708) can be between about 0.060 inches and about 0.080 inches, and the width (4716) can be between about 0.030 inches and 0.080 inches. In some cases, the length of the injection hole (4708) can be about 0.080 inches, and the width can be about 0.030 inches. In other variations, the length (4714) of the injection hole (4708) may be approximately 0.080 inches and the width (4716) may be approximately 0.080 inches.

[0201] In some cases, the total area of ​​the plurality of injection holes (4708) may be between about 0.02 in. 2 With about 0.01in 2 Between, about 0.02in 2 With about 0.009in 2 or its area may be about 0.026in 2 or about 0.0096in 2 Additionally or alternatively, in some variations, the injection holes (4708) may each have the same area. For example, in some variations, the area of ​​each injection hole (4708) may be between about 0.0006 in. 2 With about 0.0088in 2In some cases, the area of ​​each injection hole (4708) can be between about 0.0064in 2 With about 0.0024in 2 The area is at least about 0.0024 in 2 or at least about 0.0064in 2 .

[0202] In some variations, the injection hole (4708) can occupy about 10%-55%, 35%-45%, 38%-42%, 39%, or 40% of the surface area of ​​the distal portion (4706) of the injection tip (4630) (calculated based on the total surface area of ​​the completely closed distal portion (4706)). In other words, the hole can open the distal portion (4706) by about 10%-55%, 35%-45%, 38%-42%, 39%, or 40%. In some variations, the injection hole (4708) can occupy greater than about 20%, greater than about 25%, greater than about 30%, greater than about 35%, or greater than about 40% of the surface area of ​​the distal portion (4706) of the injection tip (4630), or the distal portion (4706) can be open by about 20%, about 25%, about 30%, about 35%, or about 40%. In some variations, injection hole (4708) may define between about 35%-45%, between 38%-42%, 39%, or 40% of the distal circumference of injection tip (4630). In some cases, injection hole (4708) may define greater than about 20%, greater than about 25%, greater than about 30%, greater than about 35%, or greater than about 40% of the distal circumference of injection tip (4630).

[0203] Although different embodiments may include different numbers of injection holes and / or injection holes of different sizes, using injection holes (4708) that cover a larger surface area (e.g., greater than 20%) of the distal portion (4706) or, in other words, using a distal portion (4706) that is open greater than 20% can advantageously direct the contrast fluid along or near the outer surface of the injection tip (4630), which can prevent or reduce the likelihood that the contrast fluid will be ejected radially outward from the injection tip (4630) or otherwise disperse rapidly. Thus, in some variations, using larger injection holes or a more open distal portion can allow a user to better locate and / or confirm the shape of the target tissue, confirm attachment to the target tissue, and / or confirm closure of the target tissue.

[0204] Go to Figures 48A-48C , the figure depicts respectively Fig.46A and 46B, a front perspective view, a rear perspective view, and a side view of the suction tip (4620) of the closure device (4600) depicted in . The suction tip (4620) may include a conical proximal portion (4802), a cylindrical distal portion (4804), and a lumen (4806) therethrough. The proximal portion of the lumen (4806) may be configured to receive the distal portion of the elongated body (4610) to couple the suction tip (4620) to the elongated body (4610). The lumen (4806) may terminate at a suction hole (4808) at its distal end, which is configured to be coupled to a target tissue. In other words, the suction hole (4808) may be in fluid communication with a vacuum lumen in the elongated body to apply suction to the target tissue. The suction tip (4620) can have a first diameter at the proximal end of the suction tip (4620) (i.e., at the proximal end of the conical proximal portion (4802)) and a second diameter at the distal end of the suction tip (4620). The first diameter can be smaller than the second diameter. In addition, the first diameter can be larger than the diameter of the elongated body. In some variations, the first diameter can be between about 0.063 inches and about 0.065 inches, or can be about 0.064 inches. The second diameter can be between about 0.253 inches and about 0.257 inches, or can be about 0.255 inches.

[0205] The conical proximal portion (4802) of the aspiration tip (4620) can include an outer surface that is angled relative to the longitudinal axis of the closure device (4600), which can assist in injecting fluid distally from the injection hole in the injection tip. In some variations, the angle between the outer surface of the conical proximal portion (4802) and the longitudinal axis of the aspiration tip (4620) can be between 25 and 35 degrees, between 20 and 30 degrees, between about 20 and 40 degrees, or can be about 25 degrees, about 30 degrees, or about 35 degrees.

[0206] In addition, the lumen (4806) can have a first diameter in the conical proximal portion (4802) and can have a second diameter in the cylindrical distal portion (4804), and the first diameter can be smaller than the second diameter. For example, in some variations, the first diameter of the lumen (4806) can be between about 0.063 inches and about 0.065 inches, and the second diameter of the lumen (4806) can be between about 0.221 inches and about 0.225 inches. In some embodiments, the first diameter can be about 0.064 inches, and the second diameter can be about 0.223 inches. In some variations, the second diameter of the lumen (4806) can be between 3 and 4 times larger than the first diameter of the lumen (4806), can be about 3 times, or can be about 4 times.

[0207] In addition, the suction tip (4620) can have any suitable length. For example, the length of the suction tip (4620) can be between about 0.395 inches and about 0.405 inches, or can be about 0.40 inches. In some cases, the length of the conical proximal portion (4802) can be between about 0.075 inches and 0.085 inches, or about 0.80 inches, and the length of the cylindrical distal portion (4804) can be between about 0.315 inches and about 0.325 inches, or about 0.320 inches. Therefore, in some variations, the cylindrical distal portion (4804) can be longer than the conical proximal portion (4802). For example, the length of the cylindrical distal portion (4804) can be at least twice, three times, four times, five times, between two and four times, or between three and four times the length of the conical proximal portion (4802).

[0208] Fig.49 An exploded view of a distal portion of a closure device (4900) is depicted, the closure device comprising an elongated body (4910), an aspiration tip (4920), an injection tip (4930), a guide wire (4940), and a marker (4950). Additionally, as will be discussed in greater detail herein, the device (4900) may further comprise a coil positioned around a portion of the guide wire (4940). The injection tip (4930) may comprise a portion of the guide wire (4940). Figures 47A-47C any of the features described for the injection tip (4630) depicted in FIG. 1 , and the aspiration tip (4920) may include any of the features described for the injection tip (4630) depicted in FIG. Figures 48A-48C . For example, the injection tip (4930) may include a proximal portion (4902), a middle portion (4904), a distal portion (4906), and a lumen passing through the injection tip. The distal portion (4906) may include a plurality of (e.g., four) injection holes (4908) and a plurality of (e.g., 4) arms (4909). The suction tip (4920) may include a proximal portion (4922), a distal portion (4924), a lumen (4926) passing therethrough, and a suction hole (4928). The elongated body (4910) may include a vacuum lumen (4914) and a contrast fluid lumen (4916). In some embodiments, and as Fig.49 , the vacuum lumen (4914) can be longer than the contrast fluid lumen (4916), such that the elongated body (4910) can include a distal extension (4918). The distal extension (4918) can define a distal portion of the vacuum lumen (4914), such that the distal end of the vacuum lumen (4914) can extend beyond the distal end of the contrast fluid lumen (4916).

[0209] The injection tip (4930) and the aspiration tip (4920) can each be coupled to the elongated body (4910), and the injection tip (4930) can be positioned proximal to the aspiration tip (4920). For example, the elongated body (4910) can be positioned within the lumen of the injection tip (4930) such that the proximal portion (4902) of the injection tip (4930) is coupled to the outer surface of the elongated body (4910). The injection tip (4930) can be positioned such that the contrast fluid lumen (4916) terminates within the injection tip (4930), such as within the middle portion (4904) or the distal portion (4906). The distal extension (4918) of the elongated body (4910) can be positioned within the lumen (4926) of the aspiration tip (4920) such that the vacuum lumen (4914) terminates within the aspiration tip (4920), for example, within the distal portion (4924). In this manner, the injection hole (4908) can be in fluid communication with a contrast fluid source coupled to the proximal end of the contrast fluid lumen (4916) to deliver contrast fluid from the source through the injection hole (4908) to the surrounding tissue. The aspiration hole (4928) can be in fluid communication with a vacuum source coupled to the proximal end of the vacuum lumen (4914) to transmit negative pressure through the aspiration hole (4928) and couple the aspiration tip (4020) to the target tissue.

[0210] As briefly mentioned above, the closure device (4900) can include a guide wire (4940). The guide wire (4940) can be positioned within a lumen of the elongated body (4910), such as within a vacuum lumen (4914) as depicted or within a contrast fluid lumen (4916). In some variations, the guide wire (4940) can be embedded within a sidewall of the elongated body (4910). The guide wire (4940) can include a curved distal portion (4942) that can be configured to couple to a marker (4950), which can be a radiopaque marker ring. For example, the distal end of the guide wire (4940) can terminate at a marker ring (4950). As depicted, the curved distal portion can have an L-shape so that the distal-most portion of the guide wire (4940) can be parallel to the longitudinal axis of the closure device and can therefore be more easily coupled to the marker (4950) and / or the aspiration tip (4920). In some variations, the positioning of the guide wire (4940) may be fixed so as to be non-translatable relative to the elongate body (4910).

[0211] The wire (4940) can be configured to maintain its shape and / or provide kink resistance to the elongated body. In addition or alternatively, the wire (4940) can be configured to provide variable lateral flexibility along its length. For example, the wire (4940) can include a proximal portion, a central portion or an intermediate portion, and a distal portion. The length of the proximal portion can be between about 39.5 inches and about 40.5 inches (e.g., about 40 inches), and the diameter is about 0.020 inches. The length of the distal portion can be between about 3.40 inches and about 3.60 inches (e.g., about 3.50 inches), and the diameter of the distal portion can be about 0.010 inches. The length of the intermediate portion can be between about 1.45 inches and about 1.55 inches (e.g., about 1.50 inches), and have a diameter that tapers from the proximal portion to the distal portion. In some of these variations, a stainless steel helical spring having a wire diameter of approximately 0.005 inches, an inner coil diameter of approximately 0.012 inches, and an outer coil diameter of approximately 0.022 inches can be coupled to at least a portion of the distal portion of the wire. The wire (4940) and coil together can include a relatively hard proximal portion and a flexible distal region that remains kink-resistant due to the coil and provides additional flexibility to assist in maintaining attachment to the target tissue during surgery. In addition, the tapered mid-portion provides a flexible gradual transition between the proximal and distal portions. In some of these variations, the wire (4940) can be formed of braided polyimide and / or stainless steel.

[0212] In some variations, the distal portion of the guide wire (4940) may be deformed to provide a desired curvature to the closure device (4900). This may increase the maneuverability of the closure device (4900), such as by rotating (e.g., rolling) the closure device (4900) as it is advanced. In some cases, the operator may retract the closure device (4900) from the body and further deform the curvature of the guide wire (4940) in order to alter the maneuverability of the closure device (4900). Although the above description of the closure device (4900) is not limited to the embodiment of the present invention, the closure device (4900) may be deformed to provide a desired curvature to the closure device (4900). Fig.49 The closure device (4900) depicted in FIG. 4 is described with respect to a wire (4940), but it should be understood that any closure device described herein may include the described wire alone or a combination of the described wire and coil.

[0213] Return to reference Fig.49, and as described above, the closure device (4900) may include a marker (4950). The marker (4950) may be used to provide an indication of the location of the closure device in the body and / or may allow a user to track the advancement of the closure device (4900). The marker may be any suitable marker, such as a visual, radiopaque, or echogenic marker. In addition, although the marker (4950) is depicted as a ring (e.g., a radiopaque ring), it may have any suitable shape. The marker (4950) may be coupled to the closure device (4900) at any suitable location, such as on or in the aspiration tip (4920), the injection tip (4930), and / or the elongated body (4910), and the closure device may include multiple markers (4950). The marker (4950) may be coupled to or formed on the device in any suitable manner, and may be, for example, printed thereon, attached with an adhesive, embedded within a component, a combination thereof, and the like. In some variations, the injection tip (4930) may include an echogenic surface as described in more detail herein. Although about Fig.49 Described, however, any closure device described herein may include a marker (4950).

[0214] Figures 50A-50B A side view and a side cross-sectional view of the distal end of a closure device (5000) are depicted, respectively, the closure device comprising an elongated body (5010), an aspiration tip (5020), an injection tip (5930), a guide wire (5940), and a marker (5050). The injection tip (5030) may include a guide wire (5940) and a marker (5050). Figures 47A-47C The injection tip (4630) may include any of the features described in the embodiment of the present invention, and the aspiration tip (5020) may include any of the features described in the embodiment of the present invention. Figures 48A-48C , and any features described in connection with the suction tip (4620) depicted in . For example, the injection tip (5030) may include a proximal portion (5002), a middle portion (5004), a distal portion (5006), and a lumen passing through the injection tip. The distal portion (5006) may include a plurality of injection holes (5008) and a plurality of arms (5009). The suction tip (5020) may include a proximal portion (5022), a distal portion (5024), a lumen (5026) passing therethrough, and a suction hole (5028). The elongated body (5010) may include a vacuum lumen (5014) and a contrast fluid lumen (5016). In Figures 50A-50B In the variation depicted in , the aspiration tip (5020) is fixedly coupled to the injection tip (5030).

[0215] The suction tip (5020) and the injection tip (5030) can be coaxially and concentrically arranged. The proximal portion (5022) of the suction tip (5020) can be positioned within the distal portion (5006) of the injection tip (5030). Therefore, a portion of the suction tip (5020) can be nested in the injection tip (5030). The distal end of the injection tip (5030) (i.e., the distal end of the arm (5009)) can be nested or otherwise coupled to the proximal portion (5022) of the suction tip (5020). In a variant in which the arm (5009) includes an angled distal surface, the angle of the distal surface can correspond to the angle of the outer surface of the proximal portion (5022) of the suction tip (5020), so that the distal surface of the arm (5009) of the injection tip (5030) is flush with the outer surface of the proximal portion (5022) of the suction tip (5020). In some variations, the distal surface of one or more arms (5009) can be fixedly attached to the outer surface of the proximal portion (5022) of the aspiration tip (5020), which can fix the positioning of the aspiration tip (5020) relative to the injection tip (5030). The predetermined or fixed distance between the distal end of the aspiration tip (5020) and the injection tip (5030) can provide a buffer between tissue (e.g., cardiac tissue) drawn into the aspiration aperture (5028) and any contrast fluid injected from the injection aperture (5022).

[0216] The aspiration tip (5020) and the injection tip (5030) can each have a distal portion (5024, 5006), which can be cylindrical in some variations. The distal portions (5024, 5006) can each include a diameter. In some embodiments, such as Figures 50A-50B In the illustrated embodiment, the diameter of the distal portion (5024) of the aspiration tip (5020) can be approximately equal to the diameter of the distal portion (5006) of the injection tip (5030). In other embodiments, the diameter of the distal portion (5024) of the aspiration tip (5020) can be greater than the diameter of the distal portion (5006) of the injection tip (5030). In addition, in some cases, the distal portions (5024, 5006) of the aspiration tip (5020) and the injection tip (5030) can have different shapes. For example, the distal portions (5024, 5006) can have an elliptical, square, rectangular, or other cross-sectional shape.

[0217] The elongated body or tube as described herein may include one or more suitable cross-sectional shapes, such as circular, oval, D-shaped, triangular, etc. In some variations, the cross-sectional shape of the tube may vary along its length. The tube may include one or more parts, and the length of each part may be the same as or different from the other parts. The tube may further include one or more transitions connecting the parts of the tube together. For example, one or more parts of the tube may be flexible to manipulate the distal end of the tube toward a desired position (e.g., using a pull wire). The tube described herein may include any suitable length and outer diameter, and the length and diameter of the tube may vary depending on the type of surgery performed. In some variations, the outer diameter of the tube may also vary along its length. The tube may be made of any suitable material, such as one or more polymers (e.g., enhanced polyetheramide, polyimide, polyether block amide, polyethylene, silicone, polyvinyl chloride, latex, polyurethane, PTFE, nylon, combinations thereof, etc.). In some variations, the injection tip (4130) may include a rigid polymer (e.g., stainless steel, plastic (such as ultem), ABS, polycarbonate, combinations thereof, etc.).

[0218] although Figures 40A-40B The devices depicted in , 41A-41B, 42A-42C, 44A-44B, 45A-45C and 46A-46D, 49 and 50A-50B are described above as closure devices, but the devices depicted herein can be provided and / or used independently of the ligation devices described herein (e.g., closure device (200)). For example, in some cases, these devices (4000, 4100, 4200, 4400, 4500, 4600, 4900, 5000) can be tissue stabilization and / or visualization devices (also referred to herein as tissue stabilization devices) and can be used to stabilize and / or visualize target tissue without the need for concurrent use of a ligation device or a closure device.

[0219] Imaging device

[0220] The closure device described herein may also include an imaging device, which can be used to facilitate the advancement and placement of the closure device relative to the target tissue. Providing an imaging device in the lumen of the vacuum tube can help the user visualize the tissue in front of and / or around the suction tip of the vacuum tube, which may be useful throughout the closure surgery. For example, in a left atrial appendage closure surgery, when the closure device is percutaneously advanced to the pericardial space, the imaging device can provide useful information to assist in guiding the closure device toward the left atrial appendage. In addition, before and during the application of vacuum by the vacuum tube, the left atrial appendage can be imaged to guide the vacuum tube toward, for example, the apex of the left atrial appendage, thereby assisting in placing the vacuum tube to serve as a guide for the desired position of the closure element on the tissue. After the suction has been released, the left atrial appendage can be imaged to confirm the ligation of the left atrial appendage and assist in extracting the closure device from the main body. In some cases, the imaging device can confirm that the snare ring assembly is transformed into an open configuration, and confirm that the vacuum tube advances through the open snare ring assembly.

[0221] Fig. 4I Variations of closure device (400) are depicted that include imaging device (434). In some variations, and as Fig. 4I As depicted in , the imaging device (434) can be coupled to or otherwise positioned at the suction tip (432) of the vacuum tube (430). Fig. 4I In the illustrated variation, the imaging device (434) is housed within the lumen (440) of the vacuum tube (430), but it need not and may instead be coupled to any suitable portion of the vacuum tube (430) (e.g., coupled to a lateral outer surface of the aspiration tip, a forward-facing portion) or the elongated body (402). In some instances, it may be desirable to position the imaging device (434) on or within the vacuum tube, as this may allow a user to better visualize the location of the target tissue relative to the vacuum tube, and may make it easier to guide or otherwise position the aspiration tip (432) of the vacuum tube (430) at or on the tissue, where the snare loop assembly will be properly positioned to advance to a desired location on the tissue for closure. Additionally, positioning the imaging device (434) within the vacuum tube may allow an operator to image tissue being drawn into the vacuum tube, which may assist in confirming capture of the desired tissue (e.g., left atrial appendage tissue).

[0222] The imaging device (434) can have any suitable diameter and length. For example, the diameter of the imaging device (434) can be up to about 6 mm, including a diameter of about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, between about 3 mm and about 5 mm, between about 4 mm and about 6 mm, or between about 5 mm and about 6 mm. The imaging device (434) can include any suitable length, such as a length of about 20 mm, about 23 mm, about 25 mm, between about 20 mm and about 25 mm, between about 20 mm and 23 mm, or between about 23 mm and about 25 mm. In one variation, the diameter of the imaging device (434) can be about 5.5 mm and the length can be about 23 mm.

[0223] The imaging device (434) can be configured to allow a user to view the suction tip (432) of the vacuum tube (430), the snare loop assembly (404), and / or tissue in front of or around it during surgery. The suction tip (432) of the imaging device (434) can be positioned within the suction tip (432) of the vacuum tube (430) so that tissue can be drawn into the vacuum tube (430) and can be distinguished using imaging as it is drawn into the vacuum tube (430). The imaging device (434) can be any device that helps a user view the elongated body (402), the snare, the suture loop, and / or tissue. For example, in some variations, the imaging device (434) can include a camera having an image sensor (e.g., a CMOS or CCD array with or without a color filter array and associated processing circuitry) that can be positioned at the suction tip of the vacuum tube (430). An external light source (e.g., a laser, LED, lamp, etc.) can generate light that is delivered to the suction tip of the vacuum tube via a fiber optic cable, or the imaging device (434) can include one or more LEDs to provide illumination. For example, the imaging device can include a flexible fiber bundle (e.g., a fiberscope) with a diameter of up to about 2 mm. The fiberscope can be configured to receive and transmit light from an external light source. The fiberscope can include an image sensor that is configured to receive light reflected from the pericardial anatomical structure. The image sensor can detect the reflected light and convert it into an image signal that can be processed and emitted for display. The camera can also include an optical device (e.g., a lens). In other variations, the imaging device (434) can include an endoscope that can be slidably positioned in the lumen (440) of the vacuum tube (430). The endoscope can have any suitable configuration, for example, it can be a chip-on-the-tip camera endoscope, a three-camera endoscope, etc. In yet other variations, the imaging device (434) can include an ultrasound catheter. It should be understood that the imaging device (434) may include any device that allows or facilitates visualization of the internal structure of any portion of the closure device and / or the body.

[0224] As the vacuum tube and imaging device advance through the pericardial space, tissue pressed against the opening of the suction tip of the vacuum tube may be compressed. The imaging device, including any light source used for illumination, may be housed in a sealed (waterproof) housing. This tissue may be pressed against the imaging device and obscure the view from the imaging device. For example, the distal end of the housing of the imaging device may be located between about 0.20 cm and about 2.0 cm from the opening of the suction tip of the vacuum tube. In some embodiments, the distance between the imaging device and the opening of the vacuum tube may reduce and / or prevent contact between the tissue and the imaging device. For example, the space between the distal end of the imaging device and the opening of the vacuum tube may provide a minimum field of view for the imaging device. With a clear field of view, tissue such as left atrial appendage tissue may be more easily distinguished from myocardial tissue and pericardial tissue.

[0225] In some variations, a connector (438) can connect the imaging device (434) to a power source, a processor, and / or a display to provide power, control signals, and / or transmit image signals. The image signal can be transmitted to the display by wire or wirelessly for viewing by the user. In some variations, the imaging device (434) can be separated from the closure device and can be advanced through the lumen of the vacuum tube before or during surgery, or along a track formed along the outer surface (e.g., top, bottom, side) of the closure device. In yet other variations, the closure device can include an imaging device (434) as described above, and a separate imaging device (e.g., endoscope, ultrasound catheter, etc.) can also be advanced through different entry sites to supplement the visualization provided by the imaging device (434) of the closure device (400).

[0226] During surgery using the closure device described herein, a user can view images generated by the imaging device (434) in real time on a display and use the images to assist in the tissue closure process. For example, the images generated by the imaging device (434) can help the user identify the position of the closure device within the subject and ensure that the surgery is applied to the correct anatomical structure. For example, when the target tissue is the left atrial appendage, it may be useful to treat the left atrial appendage as a closure device, and more specifically, the vacuum tube approaching the atrial appendage. This is because it is important to ligate the left atrial appendage in the appropriate position (e.g., at the base) to obtain effective closure and minimize leakage. When the closure device and specifically the vacuum tube approach the atrial appendage, the ability to view the atrial appendage can allow the user to better position the suction tip of the vacuum tube relative to the atrial appendage for tissue closure, which is ready to advance the closure element to the appropriate position. For example, because the relative position of the vacuum tube and the snare ring assembly is known, once the vacuum tube is properly positioned, the vacuum tube can be used as a guide to advance the snare ring assembly to the atrial appendage and advance it to the desired position around the atrial appendage.

[0227] More specifically, in some cases, the imaging device (434) can visualize the anterior lobe (apex) of the left atrial appendage, which can assist in guiding the vacuum tube (430) toward a desired contact location with the atrial appendage, which in some variations can be on the anterior lobe of the left atrial appendage. Placing the vacuum tube (430) at the desired contact location can allow the snare loop assembly (404) to be advanced around and over the anterior lobe of the left atrial appendage and toward the base or ostium of the left atrial appendage.

[0228] exist Fig. 4I In the embodiment depicted in , when the vacuum tube (430) is releasably coupled to tissue (i.e., using suction), the imaging device (434) within the lumen (440) of the vacuum tube (430) may not be able to visualize the advancement of the snare loop assembly (404) over and around the left atrial appendage because the tissue may partially or completely block the imaging device (434). However, releasably coupling the vacuum tube (430) to the left atrial appendage can ensure that the snare loop assembly (404) is properly positioned for advancement over the apex of the left atrial appendage to the ostium.

[0229] Figures 12A-12D are illustrative images from an imaging device placed in a closed device. Fig. 12A An image captured by an imaging device from within the lumen (1200) of the suction tip of the vacuum tube is shown. Heart tissue (left atrial appendage tissue (1202) and pericardial tissue (1204)) is in contact with the opening of the lumen (1200). Fig. 12A In the figure, the left atrial appendage (1202) can be easily distinguished from the pericardial tissue (1204) due to its deep red color and pulsating motion. Therefore, the image from the imaging device can assist in visually locating the left atrial appendage for guiding the closure device. Fig. 12B is an image from the imaging device as the left atrial appendage tissue (1202) is drawn into the distal lumen (1200) by one or more of the vacuum and advancement of the vacuum tube. The image can confirm that the vacuum tube has drawn into the left atrial appendage tissue (1202) and not the pericardial tissue (1204). Fig. 12C is a subsequent image from the imaging device as the left atrial appendage tissue (1202) is drawn further into the distal lumen (1200) and begins to provide a blurred image. Figures 12A-12C LAA tissue (1202) is shown being drawn into the distal lumen (1200) without the application of negative pressure vacuum, although a vacuum may be created when the LAA is first visualized and / or located.

[0230] Once the left atrial appendage tissue (1202) has been drawn into the distal lumen, preferably with a minimal gap between the left atrial appendage tissue (1202) and the inner wall of the aspiration tip of the vacuum tube, the vacuum may be activated. Fig.12Dis an image of the left atrial appendage tissue (1202) being drawn into the distal end of the lumen (1200) such that the image is obscured by the left atrial appendage tissue (1202), thereby providing confirmation to the vacuum tube that the tissue (1202) is captured and retained.

[0231] It should be understood that the closure devices described herein may use additional visualization devices including direct and indirect visualization techniques. As briefly mentioned above, in some variations, a second imaging device may be coupled to the outer surface of the elongated body or vacuum tube to allow visualization of the snare ring assembly as it is advanced around the left atrial appendage. In these variations, the second imaging device may be fixedly or releasably coupled to the outer surface of the elongated body or vacuum tube using any suitable means (e.g., adhesives, bonding, snap-fit ​​elements, combinations thereof, etc.). In some cases, additional imaging devices (i.e., in addition to the first imaging device or the second imaging device described above) may be advanced separately to assist in visualization of the snare ring assembly advanced around the left atrial appendage and / or placement of a suture ring around the left atrial appendage. In addition, as described below, other visualization techniques may also be used to assist in visualization of the closure procedure.

[0232] In some variations, the closure device described herein can be used with additional visualization devices and / or visualization techniques, including but not limited to CT, intracardiac echocardiography (ICE), magnetic resonance imaging (MRI), 3mensio, guided tracking (e.g., mapping data merged with CT data), fluoroscopy, direct optical imaging (e.g., camera), transesophageal electrocardiogram (TEE), EKG, fusion (e.g., fluoroscopy data merged with CT data), fluorescence, and ultrasound. In some variations, the closure device described herein can be used in conjunction with a visualization catheter positioned in one or more of the coronary sinus and the pulmonary artery. For example, a multipolar catheter can be placed in the coronary sinus (running just below the base of the atrial appendage) and can be used to locate the apex of the left atrial appendage. A second catheter can be placed in the pulmonary artery and can be used to locate the inner edge of the heart. These catheters can be configured as fluoroscopic landmarks that can indicate that the mouth of the LAA is located between the acute angles formed by the intersection of the two catheters. In some variations, one or more of ICE, fluoroscopy, optical imaging, EKG, mapping, and fusion can be used during the capture of the LAA and / or confirmation of the capture of the LAA. In some cases, fluoroscopy, optical imaging, EKG, mapping, and fusion may be used during advancement.

[0233] In some variations, fluorescence (e.g., near-infrared fluorescence, laser-induced fluorescence (LIF)) can be used to assist in determining the location of specific cardiac tissue and / or one or more of the devices described herein. For example, in some variations, the imaging device may include a light source configured to generate one or more of near-infrared light (NIL) and light for laser-induced fluorescence (LIF), or it may include one or more optical fibers configured to transmit such light generated by an external light source (e.g., on one or more lasers, light-emitting diodes (LEDs), etc.). The imaging device may further include one or more optical sensors configured to receive an emission spectrum reflected from the tissue. Because different types of cardiac tissue (e.g., left atrial appendage, myocardium, aorta, ventricle, adipose tissue) can produce different and unique emission spectra when excited by NIL and / or light for LIF, it can be distinguished between different types of cardiac tissue based on the detected emission spectra (and thus determine the positioning of one or more of the devices described herein relative to the tissue). The received emission spectral data can be analyzed by a processor (contained within or external to the imaging device) to classify one or more of the imaged tissue, vacuum tube, and closure device. In some variations, the received emission spectral data can be used to determine the position and / or orientation of the closure device relative to the left atrial appendage.

[0234] Figures 21A-21B is a perspective view of a closure device (2100) comprising an elongated body (2104) and an imaging assembly (2110) disposed on the exterior of the elongated body (2104), the imaging assembly being able to assist in the visualization of cardiac tissue. Specifically, as the snare loop is advanced toward the left atrial appendage, the imaging assembly (2110) disposed on the exterior of the elongated body (2104) can assist in the visualization of the snare loop and / or tissue. In some variations including a vacuum tube, the imaging device can visualize one or more of the snare loop, tissue, and the vacuum tube. Additionally, the imaging assembly (2110) can assist a user in confirming that the suction tip of the vacuum tube is stable against the left atrial appendage. The snare loop can be imaged as it is advanced over the left atrial appendage. As shown in FIG. Fig.21AAs shown, the closure device (2100) can include a distal end (2102), an elongated body (2104), a handle (2106), and a snare loop assembly (2108). The handle (2106) can be coupled to the proximal end of the elongated body (2104), and the handle (2106) can be used to move the snare loop assembly (2108) between an open configuration and a closed configuration, control the imaging device (2114), release the suture loop from the snare loop assembly, and / or control the vacuum pressure applied to the target tissue through the vacuum tube. The handle (2106) can further include an imaging device control, which can control the operation of the imaging device (and the movement of the imaging device relative to the vacuum tube and / or the elongated body (2104)).

[0235] If you can Fig. 21B As seen in the drawings, the imaging assembly (2110) can include one or more fasteners (2112), an assembly housing (2216), and an imaging device (2114). The imaging device (2114) (e.g., a camera, an endoscope, a fiberscope, an external light source and image sensor, an ultrasound catheter, etc.) can be disposed in the assembly housing (2116). In some variations, the imaging device (2114) can be battery powered or connected to a power source via a set of electrical conductors (e.g., insulated leads). The imaging assembly (2110) can be slidably coupled to the elongated body (2104) via the fastener (2112). For example, the fastener (2112) can surround the elongated body (2104) and can allow the imaging device (2114) to be slidably positioned while maintaining a consistent orientation relative to the elongated body (2104). The imaging device (2114) can be positioned in the lumen of the assembly housing (2116) such that the imaging device (2114) is angled relative to the longitudinal axis of the elongated body (2104). For example, the assembly housing lumen can be angled such that the imaging device positioned in the lumen is also angled relative to the longitudinal axis of the elongated body (2104). Alternatively, the assembly housing lumen can be substantially parallel to the longitudinal axis of the elongated body, and the imaging device can be positioned in the lumen at an angle relative to the longitudinal axis. This can allow the imaging device (2114) to have a field of view that is less obstructed by the elongated body (2104), and can allow a larger portion of the snare loop to be imaged.

[0236] In some variations, the imaging device (2114) can be between about 2 cm and about 8 cm from the distal tip (2103). In some variations, the imaging device (2114) can form an angle of up to about 10 degrees with the elongated body (2104). In some variations, the imaging device (2114) can have a field of view of about 90 degrees to about 120 degrees. In some variations, the length of the imaging assembly (2110) can be between about 1 cm and about 3 cm and its height can be between about 6 mm and about 9 mm. In some variations, the imaging assembly (2110) can be coupled to a control wire (e.g., a pull wire) (not shown), which can be advanced / retracted by an operator (e.g., using an actuator coupled to a handle) to slidably position the imaging assembly (2110) along the length of the elongated body (2104).

[0237] Fig. 22 2 is a perspective view of another variation of a sheath (2200) comprising an elongated body (2202) having a plurality of lumens (e.g., two). The distal end (2204) of the sheath (2200) may include a distal tip (2206) as described herein. The elongated body (2202) and the distal tip (2206) may each include at least a first lumen (2208) and a second lumen (2210). The sheath (2200) may be used in conjunction with a closure device comprising a snare loop assembly and / or a vacuum tube (neither of which is shown) slidably positioned within the first lumen (2208) of the elongated body (2202). In some variations, the snare loop assembly may be slidably advanced or retracted on a vacuum tube disposed within the first lumen (2208). An imaging device (not shown) (e.g., an endoscope) may be slidably positioned within the second lumen (2210) of the elongated body (2202). In some variations, the distal opening of the second lumen (2210) can be positioned at most about 1.0 cm from the distal end of the imaging device to set a minimum field of view and act as a buffer (e.g., empty space) for tissue that may be inadvertently drawn into the second lumen (2210) of the elongated body (2202). That is, the buffer can prevent contact between tissue and the distal end of the imaging device. In some variations, the distal opening of the second lumen (2210) can be between about 0.2 cm and 2.0 cm from the distal end of the imaging device. In some variations, the imaging device can be fixed relative to the elongated body (2202).

[0238] like Fig.13AAs shown, the closure device (1300) may include an imaging device (1324) disposed outside the vacuum tube (1310) to assist in visualization of cardiac tissue, the vacuum tube (1310) and the elongated body (1302) of the closure device (1300). Specifically, as the snare ring advances toward the left atrial appendage on the vacuum tube (1300), the imaging device (1324) disposed outside the vacuum tube (1310) can assist in visualization of the snare ring. In addition, the imaging device (1324) can assist the user in confirming that the suction tip of the vacuum tube is stable against the left atrial appendage. Then, as the snare ring advances on the left atrial appendage, the snare ring can be imaged. The imaging device (1324) can be coupled to the imaging tube (1320) and can extend proximally to be coupled to a handle (not shown). Imaging device controls disposed in the handle can control the operation of the imaging device (1324) and movement relative to the vacuum tube (1310) and the elongated body (1302). A snare loop (not shown) can be advanced over one or more of the vacuum tube (1310), the imaging tube (1320), and the imaging device (1324). In some variations, the opening of the imaging tube (1320) can be positioned at most about 1.0 cm from the distal end of the imaging device (1324) to set a minimum field of view and act as a buffer for tissue that may be inadvertently drawn into the lumen of the imaging tube (1320). In some variations, the opening of the imaging tube can be between about 0.2 cm and 2.0 cm from the distal end of the imaging device (1324). In some cases, the opening of the imaging tube can be about 1.0 cm from the distal end of the imaging device (1324).

[0239] The imaging device (1324) may be slidably coupled to one or more of the elongated body (1302) and the vacuum tube (1310) via a fastener (1326). The fastener (1326) may surround the elongated body (1302) and may allow the imaging device (1324) to be slidably positioned while maintaining a consistent orientation relative to the elongated body (1302). The fastener (1326) may couple the imaging device (1324) to a skived region (1314) of the elongated body (1302).

[0240] The imaging tube (1320) can extend through the lumen in the elongated body (1302) and be coupled to the handle of the closure device. The imaging tube (1320) can be advanced and / or retracted in a manner similar to that of a vacuum tube. For example, the imaging tube (1320) can be coupled to a sliding actuator (such as a slider) in the handle or any other suitable control (e.g., a button, a knob, a switch, etc.) in the handle. The imaging tube (1320) can include a lumen that can accommodate signal and power conductors. For example, in some variations, the conductor can include a 32AWG wire. The imaging tube (1320) can include any suitable material (e.g., spring tempered stainless steel wire) and any suitable diameter (e.g., between about 0.25 cm and about 0.50 cm). In some variations, it may be beneficial to use spring tempered stainless steel wire to increase the kink resistance of the imaging tube (1320). Additionally or alternatively, a stainless steel wire (e.g., having a diameter between about 0.25 mm and 0.50 mm and spring tempered) may extend through the imaging tube (1320) to increase kink resistance. In another variation, the imaging tube (1320) may be the same as the vacuum tube. For example, the imaging tube (1320) may include a 2 mm polyimide tube reinforced with a stainless steel wire braid and having a diameter between about 0.10 cm and about 0.50 cm. It should be understood that the closure device may include one or more of an imaging device disposed in the lumen of the vacuum tube and an imaging device disposed outside the vacuum tube.

[0241] While it may be useful to position an imaging device within the lumen of the vacuum tube to assist in visualizing tissue and / or tools within the field of view of the lumen (440), it may also be useful to use the lumen of the vacuum tube to apply negative pressure (suction) to assist in maintaining and / or stabilizing the closure device relative to the target tissue. Thus, the closure device described herein may be configured such that the imaging device may be positioned within the lumen of the vacuum tube, and the vacuum tube may still provide suction to pull the target tissue into the vacuum tube (or advance the vacuum tube (430) toward the target tissue). For example, in some variations, the imaging device (434) may be positioned such that it does not block or otherwise adversely affect the ability of the vacuum pump / vacuum tube to apply negative pressure to the target tissue. In some cases, the imaging device (434) may include an outer diameter or size that is sufficiently smaller than the inner diameter of the suction tip (432) of the vacuum tube (430) so that a vacuum may be pulled around the imaging device (434). For example, the gap between the vacuum tube and the imaging device may form a small passageway, but still allow the vacuum to be transmitted to the opening of the suction tip of the vacuum tube. In some variations, the outer diameter of aspiration tip (432) of vacuum tube (430) may be up to about 1.0 cm. In some cases, the outer diameter of aspiration tip (432) of vacuum tube (430) may be about 0.635 cm.

[0242] like Fig. 4IAs shown, in some variations, the closure device (400) may further include a fastener (436) that couples the imaging device (434) to the lumen (440) of the vacuum tube (430) to keep the imaging device (434) stationary (i.e., to keep it in place) during surgery. In some cases, the fastener (436) may include one or more side holes and / or radial holes that allow vacuum pressure to be transmitted therethrough. The fastener (436) may be positioned within the lumen (440) of the vacuum tube (430) and may be parallel to the vacuum tube (430), and in some cases concentric with the vacuum tube. For example, the fastener (434) may be positioned within the middle portion (442), the suction tip (432), or partially within each of the middle portion (442) and the suction tip (432) of the vacuum tube (430). The fastener (436) may include any suitable means for attaching the imaging device (434) to the lumen (440), including but not limited to adhesives, bonds, snap-fit ​​elements, combinations thereof, and the like. For example, in one variation, the imaging device (434) may be advanced through the second lumen (440) until the snap-fit ​​fastener secures the imaging device in place within the second lumen (440). It should be understood that the closure device described herein need not include a fastener coupling the imaging device (434) and the vacuum tube (430). For example, as described above, the imaging device (434) may be slidably disposed in the vacuum tube so that it may be advanced and retracted therethrough (e.g., an endoscope may be advanced through the vacuum tube).

[0243] As briefly mentioned above and as Fig. 4IAs depicted in , in some cases, the imaging device (434) may include a connector (438) that can couple the imaging device (434) to a power source, a processor, and / or a display. The connector (438) can include one or more wires and / or cables that can be positioned within the lumen (440) of the vacuum tube (430) and extend through the lumen to the handle / or extend through the handle for connection to a power storage device therein and / or to an external device. For example, in some variations, the closure device can include a power storage device (e.g., a disposable and / or rechargeable battery) for the imaging device within its handle, and the connector (438) can couple the imaging device (434) to the power storage device. In other variations, the connector (438) can couple the imaging device (434) to an external power source. Additionally, connector (438) may couple imaging device (434) to a processor or other control system so that control signals may be sent to imaging device (434) and image signals may be received from imaging device (434). Connector (438) may also be used to couple imaging device (434) to a monitor to display images, or to a recording device to store images for later use.

[0244] electrode

[0245] The closure device described herein may additionally or alternatively include an electrode that can be used to facilitate advancement and placement of the closure device relative to the target tissue. Providing electrodes in the lumen of the vacuum tube can help users identify the type of tissue captured in the suction tip of the vacuum tube, which may be useful throughout the closure surgery. For example, in left atrial appendage closure surgery, the closure device can be percutaneously advanced to the pericardial space using indirect visualization techniques such as fluoroscopy. The electrode can be placed in the lumen of the vacuum tube without contacting a non-suctioned tissue. For example, the electrode can be placed deep enough into the suction tip of the vacuum tube so that the tissue entering the lumen of the vacuum tube during the advancement of the vacuum tube in the pericardial space does not contact the electrode. Once positioned on the tissue (e.g., left atrial appendage) as needed, a vacuum can be applied to further pull the tissue into the lumen of the suction tip of the vacuum tube. Once pulled inside the lumen, the tissue can contact the electrode. Once the tissue contacts the electrode, the electrode can generate a signal (e.g., an electrocardiogram signal) that can be used to determine the tissue type inside the lumen of the suction tip of the vacuum tube. For example, in a left atrial appendage closure surgery, the electrode can generate a signal that can be used to determine whether the tissue inside the lumen of the vacuum tube is myocardium, pericardium, adipose tissue, or left atrial appendage. For example, a user can view the signal on an external display to determine whether the closure device is coupled to the left atrial appendage. If the signal indicates that the left atrial appendage is not positioned in the vacuum tube, the vacuum can be released, the vacuum tube can be repositioned, and the process can be repeated until the left atrial appendage is captured. After the vacuum has been released, the left atrial appendage can be imaged (e.g., using TEE, fluoroscopy) to confirm the ligation of the left atrial appendage and assist in extracting the closure device from the main body.

[0246] In some variants, the closure device may additionally or alternatively include a cardiac electrophysiology diagnostic device configured to receive electrophysiological data (e.g., electrocardiogram signals) of cardiac tissue (e.g., myocardium, pericardium, left atrial appendage). For example, the distal surface of the closure device may include one or more electrodes. The electrode may be configured to receive a signal when in contact with the tissue, and the signal may be used to determine the type of tissue and / or the position of the closure device relative to the tissue. Specifically, a mapping system may be coupled to the closure device and may be used to process the received signal to generate an anatomical map of the patient. The mapping system and / or the closure device may be used to map and position the closure device relative to the mapped cardiac structure (e.g., pericardium, myocardium, and / or left atrial appendage). The electrodes may not necessarily be used to generate a cardiac map. For example, after the closure device is advanced into the pericardium (e.g., through a percutaneous subxiphoid access site), one or more electrode connectors disposed proximal to the handle may be coupled to the mapping system. The electrode may be moved into contact with the tissue, and the electrode of the closure device may receive an electrical signal from the tissue in contact with the electrode. This data may then be used to map the position of the device relative to the mapped cardiac anatomical structure. In some variations, the user can view the generated map on a display to guide the advancement of the closure device toward a predetermined cardiac structure, such as the left atrial appendage. The same closure device can then be used to ligate the located left atrial appendage. This can allow the closure device to both map and ligate tissue, thereby reducing cost, complexity, and procedure time compared to when a separate mapping catheter is used.

[0247] In some variants, electrode signal data can be used to locate the closure device using a real-time three-dimensional heart map. For example, a group of impedance sensors placed on the patient can allow the mapping system to determine a set of coordinates of one or more electrodes of the closure device. In some variants, the three-dimensional heart map generated by the mapping system can be combined (e.g., merged) with image data generated from a preoperative CT scan of the heart. In some variants, the electrode can receive a signal from the tissue while applying a vacuum suction force, or those steps can be performed continuously in a predetermined order. In some variants, the device and / or vacuum tube may include electrodes for assisting the closure device in replacing other visualization devices, such as imaging devices (e.g., cameras, endoscopes, fiberscopes, external light sources and imaging sensors, ultrasound catheters, etc.). That is, additional imaging (e.g., from fluoroscopy or cameras) may not be necessary.

[0248] Fig.14A is a cross-sectional side view of an illustrative variation of a vacuum tube (1400) including an aspiration tip (1420) having an electrode (1402) disposed therein. Fig. 14B yes Fig.14A. A front view of the suction tip (1420) of the vacuum tube (1400) depicted in FIG. A conductor (1404) (e.g., an electrical lead) can be coupled to the electrode (1402) and can extend through the vacuum tube (1400). The electrode (1402) can be coupled to the suction tip (1420) of the vacuum tube (1400) via one or more fasteners (1406). A vacuum can be transmitted through the vacuum tube (1400) and the suction tip (1420) of the vacuum tube (1400) via one or more holes (1410) in the fastener (1406). The hole (1410) can include any shape, size, or number of openings suitable for transmitting a vacuum to the suction tip (1420). For example, the diameter of the hole (1410) can be between about 0.1 cm and about 0.3 cm. The electrode (1402) may include an atraumatic shape that does not tear, puncture, or otherwise damage tissue drawn into the lumen of the suction tip (1420) of the vacuum tube (1400). In some variations, the electrode (1402) may be radially disposed along the inner wall of the suction tip (1420) of the vacuum tube (1400). For example, Fig.41A Electrodes (4142) are shown radially disposed along the inner wall of the suction tip (4120). In this configuration, an imaging device (not shown) can be disposed in the lumen of the suction tip (1420) of the vacuum tube (1400). Alternatively, the electrode (1402) can be disposed on the housing of the imaging device (1400). In some variations, the electrode (1402) can be disposed between about 0.20 cm and about 2.0 cm from the opening of the suction tip (1420) of the vacuum tube (1400). For example, the electrode (1402) can be disposed about 1.0 cm from the opening of the suction tip (1420) of the vacuum tube (1400).

[0249] Figures 14C-14E A variation of the vacuum tube (1400) is depicted that includes one or more external electrodes (1430) disposed on a surface of an aspiration tip (1420) of the vacuum tube (1400). Each of the electrodes (1402, 1430) can be coupled to its own conductor (1404), which can extend through the length of the vacuum tube (1400). During advancement of the vacuum tube (1400) through the pericardial space, the external electrodes (1430) can contact surrounding tissue and receive electrical signals (e.g., ECG signals). Changes in the received signals can indicate movement of the vacuum tube (1400) through the pericardial space and can help an operator determine the position of the vacuum tube (1400) relative to cardiac tissue.

[0250] Figures 32A-32BA variation of a closure device (3200) is depicted that includes one or more electrodes (e.g., ECG receiving electrodes). The closure device (3200) may include an elongated body (3202), a distal tip (3204), and a snare loop assembly (3206). Fig.32B As shown, the proximal end of the elongated body (3202) can be coupled to a handle (3220). A cable (3214) can extend from the proximal end of the handle (3220) and include one or more electrical connectors (3216). The electrical connector can be coupled to, for example, a mapping system. Fig.32A , one or more electrodes (3210) can be placed on the surface of the distal tip (3204) and / or the elongated body (3202) and are configured to receive electrophysiological signals. For example, one or more electrodes (3210) can be placed on a thinned portion of the closure device (3200) (e.g., the bottom or underside surface of the elongated body). However, one or more of the electrodes (3210) can be placed on any distal portion of the closure device (3200). Each of the electrodes (3210) can be electrically coupled to a corresponding conductor (3212) (e.g., a lead) so that the electrodes (3210) can be independently wired. The conductor (3212) can extend through the lumen of the elongated body (3202) and the handle (3220) to reach the cable (3214). In some variations, the electrode (3210) can assist in identifying the position of the closure device (3200) relative to the patient's anatomical structure, as described above. The electrode (3210) may include an anti-traumatic shape that does not tear, pierce, or otherwise damage tissue. In some variations, the snare ring may include one or more electrodes. In some variations, the size of the electrode may be set to match the diameter and / or width of one or more of the elongated body (3202) and the distal tip (3204). In some variations, the closure device (3200) may include up to about 10 electrodes. The electrode may be made of any suitable material or combination of materials. For example, in some variations, the electrode may be made of conductive materials such as stainless steel, platinum, copper, combinations thereof, etc.

[0251] Lumen

[0252] The vacuum tube and the elongated body described herein can have any suitable number of lumens. As used herein, "lumen" can refer to any hole or passage extending through the length of the vacuum tube, the elongated body or other parts of the closure device (e.g., through the handle). It should be understood that the lumen does not need to be completely closed (i.e., the lumen can include one or more slots, slits, gaps or other openings along some or all of the length of the lumen). The vacuum tube and the elongated body can include one, two, three, four or five or more lumens. For example, the vacuum tube can include one or more lumens, which are configured to be used for suction and / or injection of fluid to help the imaging device clean (e.g., optical sensor, lens). Some or all of the lumens can extend completely through the vacuum tube and / or the elongated body (e.g., from the proximal end of the elongated body to the distal end of the elongated body). Other lumens can only pass through a portion of the closure device (e.g., from one end to a midpoint along the length of the device, or between two midpoints along the length of the device).

[0253] The various components of the imaging device can be housed within any lumen of the vacuum tube. The various components of the snare loop assembly can be housed within any one or more lumens of the elongated body. For example, in some variations, all of the components of the snare loop assembly can be housed in a single lumen. In other variations, different portions of the snare loop assembly can be at least partially housed in different lumens. In some variations, there can be excess suture housed within the elongated body, and this excess suture can be housed in any suitable lumen.

[0254] Reference now Figure 4D , which shows a variation of an elongated body (402) including a tip (406) and a first lumen (410) having portions having different heights. The elongated body (402) may be angled, tilted, tapered, and / or beveled in some portions, which may assist in preventing the elongated body (402) from kinking or getting stuck on tissue as it is advanced through the body. Figure 4E In the variations depicted in , different portions of elongated body ( 402 ) may correspond to specific cross-sectional shapes or diameters of elongated body ( 402 ), and in some cases, to both specific cross-sectional shapes and specific diameters.

[0255] Figure 4F-4H The elongated body (402) is respectively depicted along Figure 4D A cross-sectional view of lines FF, GG and HH. Figure 4F-4HAs shown, the FF cross section includes a cylindrical cross section having a first height (424), the GG cross section includes a D-shaped cross section having a second height (426), and the HH cross section includes a D-shaped cross section having a third height (428). In this variation, the first height (424) can be greater than the second height and the third height (426, 428). In addition, as depicted here, the second height (426) can be greater than the third height (428); however, in some cases, the third height (428) can be greater than the second height (426).

[0256] Figure 4E A cross-sectional view of an elongated body (402) is depicted including a first lumen (412) through which a vacuum tube may be slidably disposed. The elongated body (402) may further include a first snare loop assembly lumen (414), a second snare loop assembly lumen (416), a third snare loop assembly lumen (418), a first skived line (420), and a second skived line (422). As mentioned above and Figure 4G and 4H As depicted in , in some cases, the elongated body can include a D-shaped cross-sectional shape. To manufacture the elongated body having a D-shaped cross-sectional shape, a portion of the elongated body can be cut or otherwise removed.

[0257] In some variations, the first and second thinning lines (420, 422) may indicate where to cut the elongated body (i.e., at what height) to remove a bottom section thereof, thereby producing one or more portions of the elongated body including a D-shaped cross-sectional shape. Cutting the elongated body (402) at the first and second thinning lines (420, 422) may produce a D-shaped cross-sectional shape, respectively. Figure 4G and 4H Thus, the first and second thinning lines (420, 422) may correspond to the heights of the second and third heights (426, 428) of the elongated body (402), respectively.

[0258] In removing Figure 4H When the bottom section of the elongated body (402) is cut, the section of the elongated body that forms all or part of the first lumen (412) may be removed. For example, when the elongated body (402) is cut at the first thinning line (420), all (eg, Figure 4H ), and when the elongated body is cut at the second thinning line (422), only a portion of the first lumen (412) may be removed (as shown). Figure 4G ), such that the elongated body (402) may include a lumen in the form of a groove, such as may be Figure 4D Seen in.

[0259] Reference now Fig. 13B , the figure shows a variation of an elongated body (1302) comprising a first lumen (1312) and a second lumen (1322) through which a vacuum tube can be slidably disposed and through which an imaging device can be disposed. The elongated body (1302) can further comprise a first snare ring assembly lumen (1314), a second snare ring assembly lumen (1316), a third snare ring assembly lumen (1318), and a thinning line (1320). For example, the first snare ring assembly lumen (1314) can comprise a snare ring actuator lumen, the second snare ring assembly lumen (1316) can comprise a suture lumen, and the third snare ring assembly lumen (1318) can comprise a snare release locking wire lumen. In some cases, the elongated body can comprise a D-shaped cross-sectional shape. To produce an elongated body having a D-shaped cross-sectional shape, a portion of the elongated body can be cut or otherwise removed.

[0260] In some variations, the thinning line (1320) may indicate where to cut the elongated body (i.e., at what height) to remove a bottom section thereof, thereby producing one or more portions of the elongated body comprising a D-shaped cross-sectional shape. Cutting the elongated body (1302) at the thinning line (1320) may produce a portion having a D-shaped cross-sectional shape. Fig. 13C The elongated body (1302) has a cross-sectional shape as depicted in FIG. Fig. 13C When the bottom section of the elongated body (1302) is shown, the section of the elongated body (1302) that forms all or part of the first lumen (1312) and the second lumen (1322) can be removed. In some cases, the elongated body (1302) can be cut at a thinning line (1320) between about 2.5 cm and about 25 cm from the distal end of the elongated body (1302), such as between about 5 cm and about 15 cm, between about 7.5 cm and about 12.5 cm, and at about 10 cm. The first lumen and the second lumen (1312, 1322) can have different diameters or the same diameter.

[0261] As described above, the snare ring assembly described herein can be advanced over a vacuum tube to the left atrial appendage. By aligning the suction tip of the vacuum tube with the left atrial appendage, the vacuum tube can serve as a guide for the snare ring assembly and the elongated body, among other functions. In some variations, cutting the elongated body along the first thinning line and / or the second thinning line can allow the closure device to more easily access the neck of the left atrial appendage while utilizing the vacuum tube as a guide. For example, in order for the snare ring assembly or closing ring to advance around the left atrial appendage and to its neck for closure, the distal tip of the elongated body from which the snare ring assembly extends may need to be advanced past the suction tip of the vacuum tube while the suction tip of the vacuum tube remains engaged with the left atrial appendage (via suction) or otherwise aligned with the left atrial appendage. Figure 4H As shown, removing the first lumen (412) from the distal end of the elongated body (402) can allow the tip of the elongated body (402) and the snare loop assembly to travel along and through the enlarged distal end of the vacuum tube and the apex of the left atrial appendage to the neck of the left atrial appendage. After the suture loop is deployed, the elongated body (402) can then also be retracted using the vacuum tube as a guide. Therefore, the vacuum tube does not need to be repositioned to allow the distal tip of the elongated body and the snare loop assembly attached thereto to enter the neck of the left atrial appendage for closure.

[0262] Return to Figure 4E In the variation depicted in , the first lumen (412), the first snare loop assembly lumen (414), the second snare loop assembly lumen (416), and the third snare loop assembly lumen (418) can be circular. Although all of the lumens are depicted as circular, this need not be the case and the lumens can have any suitable shape. The lumens can have different diameters or the same diameter. Although the lumens are depicted in specified locations within the elongated body (402), the lumens can be positioned anywhere within the elongated body (i.e., the center of the lumen can move and its position can change).

[0263] In addition, in some variations, the lumen may include a lining or coating designed to reduce the friction between the inner surface of the lumen and the components contained in the lumen. The small size of the lumen, its relative position, the materials used, and the precision required to manufacture the elongated body may lead to manufacturing variations between different batches and / or different manufacturers (e.g., different friction characteristics inside the lumen). These variations may lead to inconsistent user experience and may lead to failure and / or inappropriate use of the closure device. For example, if the friction between the inner surface of the lumen and the suture changes, each time the device is used, the user may need to apply different amounts of force to tighten the suture. This may cause the sutures around the tissue to be over-tightened or under-tightened. Therefore, in some variations, the suture lumen may include a lining or coating (e.g., polytetrafluoroethylene (PTFE)) that reduces friction. It may be desirable to include a lining that reduces friction in any and / or all lumens of the elongated body and / or vacuum tube, because doing so can lead to a more consistent and predictable user experience.

[0264] handle

[0265] In addition to having an elongated body, vacuum tube, and snare loop assembly, the closure device typically includes one or more mechanisms for controlling the manipulation and advancement of the elongated body, vacuum tube, and / or snare loop assembly. For example, a handle or other control mechanism (e.g., a surgical master-slaverobotic system) can be used to control and actuate the vacuum tube and snare loop assembly through the elongated body.

[0266] like Figure 2As shown in Figures 4 and 5, the closure device described herein may include a handle or other control mechanism. The handle may be used for multiple purposes. For example, the handle may provide an interface between the device and the user, because the user may use the handle to hold and control the device and its components. In addition, the handle may be used to control and advance the vacuum tube through the elongated body, manipulate and / or guide the vacuum tube, actuate the gripping element, advance the imaging device through the vacuum tube, control the imaging device, and / or control the vacuum pressure applied by the vacuum tube. For example, the handle may also include one or more of the following: a snare control, a suture control, an elongated body control, a vacuum tube control, an imaging device control, and a vacuum control. These controls (e.g., actuators) may take any suitable form, such as a slider, a button, a knob, a fob, a switch, a latch, a combination thereof, and the like. For example, in some variations, the imaging device control may include a switch for activating and deactivating the imaging device and / or a slider for slidably positioning (e.g., advancing, retracting) the imaging device. The vacuum control may include a slider for pushing the vacuum tube into and advancing away from the elongated body, and a button, a switch, a knob, and the like may be used to control the negative pressure of the vacuum source.

[0267] In some cases, a handle or other control mechanism can change the snare ring assembly between a delivery or "closed" configuration and a deployment or "open" configuration, and vice versa. For example, a handle or control mechanism can be used to increase or decrease the diameter and circumference of the snare ring assembly. Placing the snare ring assembly in a closed configuration can allow the snare ring assembly to advance to a target position on the vacuum tube with a low profile and / or can allow the snare ring assembly to close around the target tissue. Conversely, placing the snare ring assembly in an open configuration can allow the snare ring assembly to be placed around one or more target tissues, and / or can allow the snare ring assembly to release one or more target tissues previously closed by the snare ring assembly.

[0268] In addition, a handle or other control mechanism can operably advance the vacuum tube from the lumen of the elongated body. Activation and control of an imaging device within the suction tip of the vacuum tube can allow visualization of tissue structures and improved positioning of a closure device for surgery. Activation and control of a vacuum pump can generate a vacuum pressure within the second lumen sufficient to provide suction at the suction tip of the vacuum tube, which can allow the closure device to be pressure attached to the tissue. An imaging device can also be positioned by the handle to confirm closure of the left atrial appendage by imaging the closed suture loop.

[0269] As shown in the variation of the closure device (400) depicted in FIG4 , the vacuum connector (452) may include a Y-shaped arm and an imaging device connector (454). In some variations, the vacuum connector (452) may be used to couple the proximal end of the vacuum tube (430) to a vacuum source (e.g., an electronic or mechanical vacuum pump). The imaging device connector (454) may be used to couple the imaging device to a device (e.g., a computer, a television, etc.) that may process and / or display images to be used during surgery.

[0270] Fig.15A is a perspective view of an illustrative variation of a vacuum control (1500) for a closure device. A portion of a handle of the closure device may include the vacuum control (1500). The vacuum control (1500) may include a switch (1502), which may be in the form of a finger-slidable control knob. The switch (1502) may actuate a connection between a vacuum source (via a vacuum source connector (1506)) and a vacuum tube (1504), thereby activating a vacuum through the vacuum tube. The vacuum source connector (1506) may couple the vacuum control (1500) to a vacuum source such as a vacuum pump, and the vacuum tube (1504) may extend distally. Figures 15B-15C yes Fig.15A 0044] A cross-sectional perspective view of the vacuum control (1500) depicted in 0045. For example, the vacuum control (1500) may further include a vacuum chamber (1510) having a compression spring (1512) and a control opening (1514) disposed therein. Fig. 15B The vacuum control (1500) is depicted with the switch (1502) in a vacuum-off position. In this position, the control opening (1514) is separated from the switch (1502) and the compression spring (1512). The switch (1502) may include a stopper to lock the switch (1502) in the vacuum-off position. The vacuum control (1500) includes a chamber (1510) that provides a common vacuum communication between an external vacuum source, the control opening (1514), and the vacuum tube (1504). Fig. 15C A vacuum control (1500) is depicted with a switch (1502) in a vacuum connection position. For example, a user can slide the switch (1502) proximally to release a stopper, and rotate the switch (1502) to allow a compression spring (1512) to slide the switch (1502) distally. The switch (1502) can include an elastomeric gasket configured to block a control opening (1514), thereby sealing the chamber (1510) and establishing a vacuum in the vacuum tube (1504).

[0271] Fig.161 is a side view of an illustrative variation of the proximal end of the handle (1600) including a vacuum source connector (1606) and a plenum chamber (1610). The plenum chamber (1610) provides a sealed chamber for separating power and data conductors (e.g., for imaging devices, electrodes) from the proximal end of the vacuum tube (1604). The plenum chamber (1610) is sealed so that the vacuum from the handle (1600) is transmitted through the suction tip of the vacuum tube (1604). The proximal end of the plenum chamber (1610) can be connected to a vacuum source connector such as a vacuum source connector (1606). Figures 15A-15C 1604 can extend into the plenum chamber (1610), wherein the lumen of the vacuum tube leads to the plenum chamber (1610), thereby allowing negative pressure to be applied through the vacuum tube (1604). Signal and power conductors from the imaging device can be coupled to the imaging device connector (1612) from inside the plenum chamber (1610). The vacuum tube (1604) and the imaging device connector (1612) can be sealed to the plenum chamber (1610) to prevent vacuum leaks.

[0272] The vacuum tube (1604) can be of sufficient length to form a loop from the end of the handle (1600) and back into the plenum chamber (1610). Thus, the relatively heavy and stiff imaging connector (1612) can be coupled to the handle (1600) rather than to the vacuum tube (1604), thereby preserving tactile control of the vacuum tube (1604) for the user. For example, the user can hold the vacuum tube at the handle to maintain stability of the left atrial appendage as it is stabilized against the vacuum tube.

[0273] The handle can be further used to control and actuate the snare loop assembly through the elongated body, manipulate and / or guide the elongated body, and / or use the pull line controlled by the handle to change the shape of the elongated body. The handle can enable the user to control the release of the suture loop from the snare, and the handle can be used to accommodate the electronic components or other related components of one or more imaging devices. In some variations, the closure device described herein may include a tensioning mechanism for managing the tension applied to a portion of the suture loop of the closure device (e.g., the tail of the suture loop). When the closure device is used to place and tighten the suture loop around the tissue, it may be desirable to manage the tension applied to the suture when the suture loop is tightened. The handle can include any suitable element to facilitate the use of the device to close the tissue, including a slider, a knob, a switch, a latch, a button, etc., which can be coupled to any component to manipulate, pull, push, open, close, unfold, activate, deactivate or otherwise use the component.

[0274] jacket

[0275] like Figure 4AAs shown, the closure device (400) can be used with a sheath (e.g., a cannula) that includes a lumen passing through the sheath (460). The closure device (400) comprising an elongated body (402) and a vacuum tube (430) can be slidably positioned within the sheath (460) and advanced through the sheath for introduction into the body. Figure 5B In another variation shown, the closure device (500) can be used with the sheath including a lumen passing through the sheath (560). The closure device (500) comprising an elongated body (502) and a vacuum tube (530) can be slidably adjacent to each other and advanced through the sheath (560) for introduction into the body. The elongated body (500) can include a snare ring assembly (504) that can be advanced and closed around tissue. The vacuum tube (530) can include a suction tip (532) of the vacuum tube (530) having an imaging device (570) disposed in the lumen of the distal end (532). As discussed above, the suction tip (532) of the vacuum tube (530) can provide stability of the closure device (500) relative to the target tissue, and the imaging device (570) disposed in the suction tip (532) can provide direct visualization of cardiac tissue.

[0276] As discussed herein, the sheath can be used to help advance one or more components (e.g., a closure device, an imaging device, a vacuum tube) into a desired portion of the pericardial cavity. In some variations, the sheath can be additionally configured to create a separation between the pericardium and the epicardium, which can assist in increasing the field of view and thus assist in visualization of the surgery. The sheath can create separation by inflating a portion of the sheath or by insufflating the pericardial cavity using the sheath. The pericardial cavity is an example of a potential space formed between adjacent structures that are normally pressed together. Fig.31A is a cross-sectional side view of a patient's anatomy including the pericardial cavity (3108). Fig.31A A heart (3100) is depicted, comprising a left atrial appendage (3102) and a pericardium (3104) covering the heart (3100). The xiphoid process (3106) is adjacent to the heart (3100). The fibrous pericardium (3104) comprises a flexible membrane sac adjacent to the epicardium, which comprises a layer of the heart (3100) immediately outside the myocardium. The pericardium (3104) is typically in contact with the epicardium. When a device (such as a sheath) is introduced into the pericardial cavity (3108), the sheath can be advanced and manipulated fairly freely through the pericardial cavity (3108). However, the pericardium typically conforms to the sheath (e.g., is draped over the sheath), so that the field of view viewed from the distal end of the sheath may be limited. In some variations, the sheath described herein can be configured to increase the separation between the pericardium and the epicardium so as to increase the field of view viewed from the distal end of the sheath for the imaging device to advance through the sheath. Thus, the advancement and visualization of cardiac structures can be improved.

[0277] In some variations, a sheath can be used to create an access site in the pericardial cavity and create a separation. Figures 29A-29E As shown, the sheath (2900) can include an elongated body (2902) having a distal end (2906). The elongated body (2902) can be coupled to an expandable member (2904). The distal end (2906) can include a soft tip as described herein. The proximal end of the elongated body (2902) can be coupled to a port (2908) configured as a conduit for fluid (e.g., gas, liquid) to travel through the elongated body (2902) and the expandable member (2904). The elongated body (2902) can include a semi-flexible polymer material as described herein, and can include multiple lumens. Fig.29C A first lumen (2910) configured to receive a closure device or an ablation device and a second lumen (2912) configured to receive or hold an imaging device (e.g., an endoscope, a fiberscope, a camera) are shown. However, the elongated body (2902) may include additional lumens, such as a third lumen that fluidly couples the port (2908) to the expandable member (2904). The number, size, and configuration of the lumens may vary based on the procedure to be performed.

[0278] In some variations, expandable member (2904) can be transitioned between a first configuration and a second configuration. For example, a fluid source (e.g., an injector filled with a liquid) can be coupled to port (2908) and can be used to introduce and / or remove fluid from sheath (2900). In variations that include an injector, an operator can depress a plunger of the injector to fill (e.g., inflate) expandable member (2904) to a position such as the first configuration. Figures 29B-29C The second configuration shown. The valve of port (2908) can be closed to allow an injector or other fluid source to be removed. When converting expandable member (2904) from the second configuration to the first configuration, a fluid source can be coupled to port (2908) and, for example, a plunger of an injector can be withdrawn to remove fluid from expandable member (2904).

[0279] In some variations, the expandable member (2904) may comprise a soft outer shell (e.g., a bag, a balloon). The balloon may be made of any suitable material or combination of materials. For example, in some variations, the balloon may be made of nylon, polyethylene terephthalate, combinations thereof, or the like. The balloon may be configured to take a particular shape or configuration when expanded in the second configuration.

[0280] Figures 29D-29EA variation of an expandable member (2904) comprising a set of deformable wires is depicted. The wires can be made of any suitable material, such as stainless steel, nickel-titanium alloy, etc. The expandable member (2904) can include a proximal ring (2920) and a distal ring (2922) coupled to the ends of the wires. In some variations, one of the rings can be fixed to the slender body (2902), while the other ring (e.g., a sliding ring) can be slidably positioned along the length of the slender body (2902). For example, a control wire (e.g., a pull wire) (not shown) can be passed through the lumen of the slender body (2902) to couple to the sliding ring. The operator can advance and retract the control wire to move the expandable member (2904) in a first configuration ( Fig.29D ) and the second configuration ( Fig.29E ) between.

[0281] In some variations, a sheath may include a curved portion and / or a deflectable portion. Figures 30A-30B A sheath (3000) is depicted that includes a portion having a predetermined curved shape that can assist an operator in aiming the sheath (3000) toward the left atrial appendage at a desired angle. The sheath (3000) can include an elongated body (3002) having a distal end (3006) and an expandable member (3004) coupled thereto. The proximal end of the elongated body (3002) can be coupled to a port (3008) as described herein. One or more of the elongated body (3002), the expandable member (3004), and the distal end (3006) can include a curved shape. As described herein, the expandable member (3004) can be in a first configuration ( Fig. 30A ) and the second configuration ( Fig. 30B ). The curved shape of sheath (3000) may allow sheath (3000) to be manipulated by rotating sheath (3000) as it is advanced through a body cavity (e.g., the pericardial cavity). Additionally, the curved shape of sheath (3000) may be configured to conform to or correspond to the curvature of one or more portions of the heart, which may assist in advancing one or more devices to a superior aspect of the heart.

[0282] In some variations, the elongated body of the sheath can include various sections or portions having different characteristics, such as different diameters, cross-sectional shapes, stiffness, materials, etc., which can increase the manipulability and operability of the sheath. For example, the elongated body can be braided, non-braided, tapered, non-tapered, or some combination thereof. Braiding can increase the torsional stiffness of the sheath while allowing the sheath to remain relatively flexible, thereby improving the overall manipulability and operability of the sheath. In some cases, at least a portion of the elongated body can be formable, meaning that the elongated body can be manipulated (e.g., bent) and can maintain the manipulated shape until a user or other applied force (e.g., from tissue within the body) further changes the elongated body.

[0283] In some variations, the distal end (3006) of the sheath (3000) can be adjustably deflectable, thereby allowing the field of view viewed from the distal end (3006) to be changed without otherwise moving the sheath (3000). The proximal end of the elongated body (3002) can be coupled to a handle (3010). The handle (3010) can include a deflection actuator (e.g., a slider, a knob, a button, a switch, etc.), which includes a control wire (e.g., a pull wire) (not shown) coupled to the deflectable distal end (3006). For example, the control wire can extend through the control wire lumen of the elongated body (3002). The distal end (3006) can be deflected in one or more directions. For example, the distal end (3006) can be deflected up to about 120 degrees in one direction.

[0284] In some variations, the sheath can be used to insufflate a gas (e.g., CO2 gas) into the pericardial cavity to create separation between the pericardium and the epicardium. Figures 35A-35B As depicted in , the sheath (3500) can include an elongated body (3502) having a distal end (3504). The proximal end of the elongated body (3502) can be coupled to a hub (3506) and a port (3508) configured as a conduit for fluid (e.g., CO2 gas) to travel through a first lumen (3510) of the elongated body (3502). The elongated body (3502) can include a semi-flexible polymer material and can include multiple lumens. Figure 35G A first lumen (3510) is shown that is configured for one or more of a closure device, an ablation device, a dilator, etc. A second lumen (3512) can be configured for or receive an imaging device (e.g., an endoscope, a fiberscope, a camera). The number, size, and configuration of the lumens can vary based on the procedure to be performed. The hub (3506) can include a radial seal coupled to the proximal end of the elongated body (3502). The radial seal is disposed within the hub (3506), such as, for example, Figures 38A-38BThe seal may circumferentially surround the shaft of a device disposed within a lumen of sheath (3500) such that CO2 introduced into one or more lumens of sheath (3500) may exit only through distal end (3504) of sheath (3500), thereby allowing the pericardial cavity to be insufflated.

[0285] Figures 38A-38C and 39A-39B depict illustrative variations of boots that include radial seals. Fig.38A The proximal end of a sheath (3800) is shown, comprising an elongated body (3802), a hub (3806) coupled to the proximal end of the elongated body (3806), and a port (3804). Figures 38B-38C is a cross-sectional side view of a hub (3806) coupled to the proximal end of the elongated body (3802). The hub (3806) can define a hub lumen (3814) that is operatively coupled to the lumen of the elongated body (3802). A radial seal (3810) can be disposed within the hub lumen (3814), can include a flexible material, and can define a seal hole (3812). The device (3808) can be advanced into the lumen of the elongated body (3802) through the radial seal (3810) and the hub lumen (3814). As used herein, the device (3808) can refer to any device described herein, such as a closure device, a vacuum tube, an imaging device, a dilator, a catheter, a combination thereof, and the like. The radial seal can be made of any suitable material or combination of materials. For example, in some variations, the radial seal can be made of silicone, a thermoplastic elastomer, a combination thereof, and the like.

[0286] The size of the seal hole (3812) can be set to have a diameter that is smaller than the diameter of the outer diameter of the device (3808). For example, the size of the seal hole (3812) can be set to be only slightly smaller than the diameter of the device (3808) to create a fluid seal while adding minimal frictional resistance to the device (3808) being guided through the sheath (3800). For example, when the device (3808) extends through the seal (3810), the radial seal (3810) can be minimally deformed (e.g., stretched). The radial seal (3810) can thus reduce, if not prevent, the escape of CO2 gas from the proximal end of the sheath (3800). In some variations, the outer surface of the device (3808) can include a low friction coating (e.g., PTFE) disposed on a portion of the device (3808) that is in slidable contact with the radial seal (3810).

[0287] Figures 39A-39B Additional variations of the proximal hub of the sheath are depicted. Fig.39AA sheath (3900) is shown, comprising an elongated body (3902), a hub (3906) coupled to the proximal end of the elongated body (3902), and a port (3904). The hub (3906) may include a Tuohy-Borst type seal system. For example, a seal control actuator (3910) may be disposed on the hub (3906). An operator may adjust the seal control actuator (3910) (e.g., a slider, knob, button, switch, etc.) to change the diameter of the seal within the hub (3906), thereby providing an adjustable seal that can accommodate devices of different diameters that are otherwise configured to move within the sheath (3900). Once a seal is formed between the hub (3906) and the device (not shown), the knob (3910) may be further adjusted to change the friction applied by the seal to the device.

[0288] In some variations, the hub of the sheath may include at least two seals. This may allow one or more devices to be removed from the lumen of the sheath while minimizing CO2 loss from the proximal end of the sheath as the device is withdrawn proximally from the sheath. Fig.39B A sheath (3900) is shown, comprising an elongated body (3902), a hub (3920) coupled to the proximal end of the elongated body (3902), and a port (3904). The hub (3920) may include a first seal controlled by a seal control actuator (3922) (e.g., a slider, knob, button, switch, etc.) and a second seal (3930) disposed proximal to the first seal. The second seal (3930) may include any suitable seal, such as a seal having a plurality of seals, such as a plurality of seals, such as a plurality of seals, and a plurality of seals having a plurality of seals. Figures 38A-38CThe fixed diameter seal, Tuohy-Borst seal, etc. described herein can be configured to form a seal around a device disposed within the lumen of the hub, and to close the lumen of the hub (e.g., to form a complete seal) when the device is not present in the lumen of the hub. This can allow the device to be advanced and retracted from the sheath (3900) with minimal loss of fluid (e.g., CO2 gas). For example, when the device is disposed in the lumen of the hub (3920) and the elongated body (3902), at least the second seal (3930) can form a seal between the hub (3920) and the device. The port (3904) can be used to introduce CO2 gas into the sheath (3900), and the gas can exit the distal end of the sheath (3900) to insufflate a body cavity such as the pericardial cavity. When it is desired to remove the device from the sheath, the device can be partially withdrawn so that the distal end of the device is disposed between the first seal and the second seal. The seal control actuator (3922) can then completely close the hub (3920) so that the aperture of the seal is zero or nearly zero. The device can then be retracted from the second seal (3930) and the hub (3920) with minimal fluid loss. The device can be introduced into the sheath by advancing the distal end of the device between the second seal (3930) and the first seal (3920) of the hub (3920). That is, the distal end of the device can pass through the second seal (3930) but not the first seal of the hub (3920). When the device is introduced into the hub (3920), the first seal can be in a completely closed state. Once the second seal (3930) forms a seal around the device, the seal control actuator (3922) can be used to open the first seal to allow the device to be advanced into the lumen of the elongated body (3902). Thus, introduction of the device into sheath (3900) may be performed with minimal fluid loss.

[0289] In some variations, a dilator may be advanced through the sheath to assist in forming the access site. Fig.35C An illustrative variation of a dilator (3520) is depicted that includes a tapered distal end (3524) and defines a guidewire lumen (3526). The tapered distal end (3524) can reduce the force required to advance the dilator (3520) and / or sheath (3500) assembly through tissue. The proximal end of the dilator (3520) can be coupled to a dilator hub (3522) that is configured to releasably connect the dilator (3520) to the sheath (3500). Figures 35D-35EAs shown, the expander (3520) coupled to the sheath (3500) can be handled as a single unit during surgery involving a guidewire, thereby improving the ease of use for the operator. The expander hub (3522) can be releasably connected to the hub (3506). The expander (3520) can include a semi-flexible polymer material, such as FEP, polypropylene, etc. In some variations, the expander (3520) can be configured to fit within the lumen of the sheath (3500). For example, the outer diameter of the expander (3520) can be only less than the diameter of the sheath lumen. In some variations, the diameter gap between the expander and the sheath can be between about 0.02mm and about 0.2mm. When the sheath (3500) is inserted and passed through the tissue, this can provide additional strength to the wall of the sheath (3500). The guidewire lumen (3526) can extend through the length of the expander (3520) and can have a diameter configured for the guidewire. In some variations, the diameter of the sheath and / or dilator may be between about 12 Fr and about 27 Fr. In some variations, the diameter of the guidewire may be between about 0.35 mm and about 1.05 mm.

[0290] In some variants, such as Figures 35F-35G As shown, the sheath (3500) can include a plurality of lumens, the plurality of lumens including a first lumen (3510) and a second lumen (3512). An imaging device (e.g., a flexible endoscope) can be disposed at the distal end of the sheath (3500) and can be coupled to a cable (3530) extending through the length of the elongated body (3502). The cable (3530) can extend out of the hub (3506). In some variations, the imaging device can be fixedly or removably disposed within the second lumen (3512). In some variations, the hub (3506) can include a radial seal configured to seal the cable (3530) and minimize fluid loss from the proximal end of the sheath (3500).

[0291] In some variations, dilator (3540) may be configured to fit within sheath (3500), and sheath (3500) may include multiple lumens (e.g., Figure 35G ).like Fig.35HAs shown, the dilator (3540) can include a tapered distal end (3544) and a guidewire lumen (3546). The tapered distal end (3544) can reduce the force required to advance the dilator (3540) and / or sheath (3500) assembly through tissue. The dilator (3540) can define a channel (3548) (e.g., a recess, a groove) that can extend through the length of the dilator. The channel (3548) can simulate the shape of the second lumen (3512) of the sheath (3500) (e.g., having a similar radius of curvature and / or a corresponding shape) so that the channel (3548) can slide over the second lumen (3512). For example, Figures 35I-35J A dilator (3540) is shown disposed within the first lumen (3510) of the elongated body (3502). Fig.35J As shown, the expander (3540) can be placed in the elongated body (3502) of the sheath (3500) so that the second lumen (3512) of the elongated body (3502) can be slidably placed in the channel (3548) of the expander (3540). Therefore, the channel (3548) of the expander (3540) can accommodate the second lumen (3512) of the sheath (3502) and the imaging device placed in the second lumen (3512). The proximal end of the expander (3540) can be coupled to the expander hub (3542) and can be configured to releasably connect the expander (3540) to the sheath (3500). The expander (3540) can be configured to fit in the lumen of the sheath (3500). The guidewire lumen (3546) can extend through the length of the expander (3540) and can have a diameter configured for a guidewire.

[0292] In some variations, a sheath configured for gas insufflation of the pericardial space may include a curved portion and / or a deflectable portion. Figures 36A-36BA sheath (3600) having a predetermined curved shape is depicted, which can assist an operator in aiming the sheath (3600) toward a target cardiac structure (e.g., pericardium, left atrial appendage) at a desired angle. The sheath (3600) can include an elongated body (3602) having a distal end (3604). The proximal end of the elongated body (3602) can be coupled to a port (3608) as described herein. One or more of the elongated body (3602) and the distal end (3604) can include a curved shape. The curved shape of the sheath (3600) allows the sheath (3600) to be manipulated by rotating the sheath (3600) as it is advanced through a body cavity (e.g., a pericardial cavity). In addition, the curved shape of the sheath (3600) can conform to the curvature of one or more portions of the heart, thereby assisting in advancing one or more devices to a superior view of the heart. In some variations, sheath (3600) may include a soft tip (3610), which may be made of any suitable material or combination of materials that is softer and / or more flexible than the remainder of elongated body (3602). Soft tip (3610) may reduce the likelihood of causing damage to tissue as sheath (3600) is advanced within the pericardial cavity.

[0293] Additionally or alternatively, in some variations, the closure device can include an expandable member coupled to a distal portion of the device. The expandable member (e.g., a balloon, a wire mesh) can be configured to create a space within the pericardial cavity to improve the field of view viewed from the distal end of the closure device.

[0294] It should be understood that the sheath, vacuum tube device, imaging device, closure device, dilator and combination thereof can each be deflectable. That is, the device described herein can be articulated to allow an operator to manipulate one or more devices through a body cavity during surgery. In some variations, one or more control wires (e.g., pull wires) can be placed through the lumen of the sheath and / or elongated body and coupled to a handle comprising a deflection control actuator at the proximal end. The distal end of the control wire can be coupled to a deflectable device so that movement of the control wire deflects at least a portion of the device in a desired direction. For example, one or more of the closure device, vacuum tube, imaging device, sheath and dilator can be deflected along multiple planes using one or more control wires.

[0295] II.Kit

[0296] The devices described herein can be combined in various kits. Typically, a kit can include one or more of a closure device, a vacuum tube, a contrast fluid tube, an imaging device, an electrophysiological diagnostic device, an introducer or sheath, and a dilator as described herein. In some variants, a kit can include one or more of a closure device, a tissue stabilization device, an imaging device, an electrophysiological diagnostic device, an introducer or sheath, and a dilator. The kit can be packaged with one or more of the devices assembled together, or can be packaged with one or more of the devices provided separately. Any of the kits described can further include instructions for use.

[0297] In some variations, a kit for closing tissue may include a closing device, a vacuum tube and a contrast fluid tube disposed in a lumen of the closing device, and an imaging device disposed in the lumen of the vacuum tube and / or externally coupled to the closing device or the vacuum tube. In some variations, a kit for closing tissue may include a closing device, a contrast fluid device, and a vacuum device disposed in the lumen of the closing device. In some of these variations, the closing device and / or the vacuum tube may include a mounting assembly (e.g., a fastener within the lumen of the vacuum tube, a fastener that may be coupled to the closing device), the mounting assembly being configured to be coupled to the contrast fluid device, wherein the contrast fluid device may be provided separately.

[0298] In other variations, a kit for closing tissue may include a closing device, a vacuum tube, and an electrophysiological diagnostic device integrated with one or more of the closing device and the vacuum tube. A contrast fluid device may optionally be included, which may be disposed within the lumen of the vacuum tube and / or the closing device, or may be separate from the vacuum tube and / or the closing device but configured to be disposed within the lumen of either. In still other variations, a kit for closing tissue may include a closing device, a vacuum tube, a contrast fluid device, and an expandable sheath configured to increase the spacing in the pericardial cavity (e.g., such as Fig. 31C The balloon sheath depicted in FIG. 1 , and Fig.37B The insufflation sheath in the embodiment of the present invention may optionally include a contrast fluid device, which may be placed in the lumen of the sheath and / or the closure device. The sheath may optionally include a dilator. Some variations may include multiple imaging devices, such as a vacuum tube and a sheath, each imaging device including a separate imaging device.

[0299] In some embodiments, the kit may include a closure device, a tissue stabilization device, and an introducer or sheath. The tissue stabilization device may be at least partially positioned within the lumen of the closure device, or the tissue stabilization device may be packaged with the closure device but may be contained in a separate package from the closure device. The kit may optionally include a source of contrast fluid, such as an injector, with or without contrast fluid. The kit may further include a dilator.

[0300] III. Methods

[0301] The closure device described herein can be used for closing tissue, such as the left atrial appendage. The closure device can use a minimally invasive method (e.g., percutaneously or through a small subxiphoid window) to enter the left atrial appendage. In use, a sheath can be used to advance the distal end of the closure device toward the target tissue (e.g., the left atrial appendage) into the main body. During advancement, the snare ring assembly can be in a closed configuration to help prevent the snare ring assembly from getting tangled or stuck in tissue or other obstacles. Similarly, the vacuum tube can be at least partially retracted into the first lumen of the elongated body (or sheath) to facilitate the closure device to advance through the limited main body space. Once the distal end of the elongated body has reached a position at or near the target tissue, the snare ring assembly can be moved into an open configuration, and the vacuum tube can advance through the hole of the snare ring assembly so that the snare ring assembly (and a small portion of the tip of the elongated body) forms a ring around the vacuum tube. In some variants, during advancement, the diameter of the hole of the snare ring assembly can be greater than the outer diameter of the suction tip of the vacuum tube. In these variations, the vacuum tube can be positioned so that the snare loop assembly can wrap around, surround, or otherwise form a loop around the suction tip of the vacuum tube during advancement. In variations in which the closure device includes an imaging device, the imaging device can be used during advancement to confirm the positioning of the closure device within the body cavity and provide visualization to assist in guiding the closure device to the target tissue, assessing the condition of the target tissue, and determining a contact location to engage and / or releasably couple the vacuum tube to the target tissue.

[0302] In order to engage the target tissue to assist in stabilizing the closure device and properly position the snare ring assembly for closure, the distal opening of the vacuum tube can be advanced to contact the tissue and draw a portion of the tissue into the lumen of the vacuum tube. Negative pressure can be used to create a vacuum in the lumen of the vacuum tube to hold the tissue in a proper position relative to the vacuum tube, which can reduce the need for additional stabilizing or guiding elements in the pericardial space or the interior of the heart. More specifically, the use of suction to releasably couple the vacuum tube to the target tissue can properly position the snare ring assembly to advance over and / or around the target tissue, such that the use of additional guides or positioning elements (e.g., balloons, magnets, etc.) may not be required. Therefore, the methods described herein can allow the use of a single entry point to close tissue.

[0303] After advancing around the target tissue, the snare loop assembly can be closed around the encircled tissue to close, ligate or otherwise restrict the target tissue. The snare loop assembly can be reopened, repositioned and reclosed as needed. In some cases, the suture loop or other restriction device can be tightened and released from the closure device to maintain closure of the target tissue. In variations where the closure device includes a tensioning device or mechanism, the tensioning device or mechanism can be used to release the suture loop from the snare loop assembly and / or tighten the suture loop. The suture loop can be tightened before and / or after the closure device is removed from the body.

[0304] To remove the closure device from the body, the snare loop assembly can be opened again to release the target tissue (the suture loop or other restriction device can remain in place) so that the snare loop assembly, vacuum tube and elongated body can be withdrawn. In some variations, the fixed end of the snare can be releasably attached to the elongated body so that after the suture loop is deployed, the snare loop assembly can be released and retracted into the elongated body. In these variations, a retraction device or mechanism can be used to release the fixed end of the snare from the elongated body and retract the snare and, in some variations, the retaining member into the elongated body.

[0305] In a variant where the snare is not releasable, the snare loop assembly can be opened (without the suture loop that may have been deployed around the target tissue) to facilitate the removal of the snare loop assembly from around the target tissue. Once the snare loop assembly is withdrawn from around the target tissue, the snare loop assembly can be closed to facilitate withdrawal from the main body low profile. The suction applied by the vacuum tube can be released before or after the suture loop is deployed and / or the snare loop assembly is opened for withdrawal. Once the vacuum tube is disengaged and / or uncoupled from the target tissue, an imaging device can be used to view and confirm the placement and tightening of the suture loop around the target tissue, and the imaging device can assist in withdrawing the closure device from the main body. In some variants, the vacuum tube can be partially or completely retracted into the elongated body to facilitate the withdrawal of the closure device from the main body. The method described herein may include any device, system and method described in U.S. application serial number 15 / 713,376 filed on September 22, 2017, the contents of which were previously incorporated by reference as a whole.

[0306] Fig.17Flowchart (1700) is an illustrative variation of a method for closing a target tissue. The method (1700) can begin by advancing a closure device through an entry site into the pericardial space (1702). The closure device can be advanced using minimally invasive techniques, for example, percutaneously (e.g., percutaneous subxiphoid entry in the pericardium) or through a small window. In some variations, a sheath can be used to introduce a closure device, a vacuum tube, a contrast tube, and / or an imaging device into a body. For example, the distal ends of the elongated body, vacuum tube, and contrast tube can be advanced through the lumen of the sheath into a body cavity such as the pericardial cavity (1704). As another example, the closure device and vacuum tube can be advanced through a first lumen in the sheath, and the imaging device can be advanced through a second lumen in the sheath. In some variations, a sheath as described herein can be advanced through the pericardial space to advance a device, such as a dilator, a closure device, a vacuum tube, an angiography tube, an electrophysiological diagnostic device (e.g., ECG receiving electrodes, a mapping catheter), an imaging device (e.g., an endoscope, a fiberscope, a camera), combinations thereof, etc., toward a cardiac structure such as the left atrial appendage.

[0307] exist Fig.31B , the sheath (3110) is shown advanced into the pericardial space (3108) between the pericardium (3104) and the epicardium of the heart (3100). For example, the sheath (3110) can be introduced into the pericardial space (3108) using a subxiphoid approach. In some variations, the sheath (3110) can be inserted into the pericardial space (3108) percutaneously or over a guide wire through a small incision. Entering the pericardial space can include inserting a needle into the midline (3106) below the xiphoid process. The needle can be advanced in an upward direction (using fluoroscopic imaging) until the needle punctures the pericardium (3104). A guide wire can then be inserted through the needle and into the pericardial space (3108). The needle can be withdrawn and one or more sheaths and, in some variations, a dilator (e.g., Figures 35C-35E , 35H-35J) can be advanced over the guidewire and into the pericardial cavity (3108). The dilator can be withdrawn from the sheath so that the lumen of the sheath can be used to advance a device such as a closure device, a vacuum tube, an angiography tube, an imaging device, a combination thereof, or the like.

[0308] In some variations, the sheath (3110) can be used to increase the separation between the pericardium and the endocardium (e.g., the space in the pericardial cavity), which can increase the field of view of the distal end of the sheath (3110). The sheath (3110) can be advanced toward the left atrial appendage (3102). The expandable member (3112) of the sheath (3110) can be in a first configuration such that the pericardium (3104) is draped over the distal end (3114) of the sheath (3110). The expandable member (3112) can be moved from the first configuration ( Fig.31B ) to the second configuration ( Fig. 31C), wherein the expandable member (3112) is expanded, which can lift the distal portion of the sheath (3110) relative to the heart (3100). Fig. 31C As shown, once the expandable member (3112) is in the second configuration, the distal end (3114) of the sheath (3110) can have a clear line of sight to the left atrial appendage (3102) and surrounding anatomical structures to assist in advancing the sheath (3110) and devices passing through the sheath (3110).

[0309] Additionally or alternatively, the sheath may be used for CO2 insufflation of the pericardial cavity to increase separation between the pericardium and epicardium, which may increase the field of view (3710) of the distal end of the sheath. Fig.37A is a cross-sectional side view of a sheath (3710) disposed in a pericardial cavity (3708), and depicts a heart (3700) including a left atrial appendage (3702) and a pericardium (3704) covering the heart (3700). The xiphoid process (3706) is adjacent to the heart (3700). The sheath (3710) is shown advanced into the pericardial cavity (3708) between the pericardium (3704) and the epicardium of the heart (3700). The sheath (3710) can be advanced toward the left atrial appendage (3702). A device (3714) (e.g., a closure device, a vacuum tube, an imaging device) can be disposed in and extend from the distal end of the sheath (3712). Fig.37A The pericardium (3704) is shown draped over a sheath (3712) and a device (3714) prior to CO2 insufflation. A CO2 gas source can be coupled to a port (3716) and can be used to insufflate CO2 into the pericardial cavity in order to separate the pericardium (3704) from the epicardium of the heart (3700), as shown in FIG. Fig.37B As shown. Thus, the field of view from within the pericardial cavity can be improved. Typically, the use of a puncture needle to pierce the pericardium to create an access site creates an opening that creates a natural seal between the pericardium (3704) and the sheath (3710), minimizing CO2 leakage from the pericardial cavity (3708). Of course, additional CO2 can be insufflated into the pericardial cavity (3708) as needed to maintain the desired interval in the pericardial cavity (3708).

[0310] The vacuum tube, contrast tube, and elongated body of the closure device can then be advanced toward a target tissue, such as a left atrial appendage (1706). For any of steps 1704-1740, contrast fluid can be injected from the contrast tube to assist in visualization via fluoroscopy. Specifically, contrast fluid can be injected to guide the closure device as it is guided toward the target tissue. It should be understood that one or more imaging devices can be used to assist in guiding the closure device toward the target tissue. For example, as described above, one or more imaging devices on the closure device can be used and / or other imaging methods, such as fluoroscopy, fluorescence (near infrared fluorescence, laser induced fluorescence), can be employed.

[0311] Once the closure device is in proximity to the target tissue, in some variations, the snare ring assembly retracted within the first lumen of the elongated body can be advanced away from the elongated body (1708) to form and / or enlarge the hole formed by the snare ring assembly. The vacuum tube can be advanced away from the first lumen of the elongated body (1710) and through the hole (1712) of the snare ring assembly. Once in the desired positioning, the target tissue within the field of view of the aspiration tip of the lumen of the vacuum tube can be imaged directly (1714). In some variations, the apex of the left atrial appendage and / or another desired contact location can be identified in an image generated by the imaging device. For example, a predetermined volume of contrast fluid can be injected into the left atrial appendage to visualize the procedure, as desired by the operator.

[0312] Once the user identifies the desired contact location, the user can advance and manipulate the vacuum tube toward the desired contact location on the target tissue (e.g., the apex of the left atrial appendage). For example, in some variations, the vacuum tube and the angiography tube can be curved, and the user can rotate (twist) the proximal ends of the vacuum tube and the angiography tube to manipulate the distal end to the desired position. Additionally or alternatively, the vacuum tube and the angiography tube can be retracted into the elongated body or otherwise positioned relative to the elongated body (e.g., where the distal end is within a closed snare ring assembly) so that the vacuum tube and the angiography tube can be manipulated with or using the elongated body of the closed device. For example, the elongated body can include a curved distal region that can be manipulated by rotating (twisting) the handle clockwise and / or counterclockwise. Rotation of the body can also result in rotation of the vacuum tube and the angiography tube so that the elongated body can be used to manipulate the vacuum tube and the angiography tube. The vacuum tube can be manipulated to contact the tissue and draw a portion of the tissue into the lumen of the vacuum tube. In some variations, the vacuum tube and the angiography tube may be intended to contact the left atrial appendage, while in other variations, the vacuum tube and the angiography tube may be intended to contact myocardial tissue near the left atrial appendage.

[0313] In some variations, one or more electrodes positioned within the aspiration tip of the vacuum tube may receive electrocardiographic signals. Figures 43A-43F is an illustrative graph of an electrocardiogram signal with the y-axis representing voltage in millivolts and the x-axis representing time in milliseconds. Fig.43A is an illustrative graph (4300) of electrocardiogram signals received from a closure device (4302) and from a surface ECG electrode (4304) prior to insertion into a patient when the vacuum tube is not in contact with cardiac tissue. In some variations, the vacuum tube and the contrast tube may be advanced out of the elongated body and advanced to contact cardiac tissue. Fig.43Bis an illustrative graph (4310) of electrocardiogram signals received from a closure device (4312) corresponding to a vacuum cup in contact with the myocardium but not drawing against the myocardium, and from surface ECG electrodes (4314). The closure device signal (4312) corresponds to a far-field ventricular signal having a downward spike that is synchronized with the QRS complex in the ECG electrode signal (4314). The signal (4312) is received when the device is in contact with the myocardium but not near the atrium or left atrial appendage. Fig.43C is an illustrative graph (4330) of electrocardiogram signals received from a closure device (4332) and from a surface ECG electrode (4334) when the electrode is in contact with the left atrial appendage but no suction is applied. Fig.43C The signal (4332) in is of relatively low magnitude and includes atrial (4336) and ventricular (4338) components. The electrocardiogram signal received from the surface ECG electrodes (4334) may include a P wave.

[0314] The vacuum pump can be activated to generate a negative pressure (1716) in the vacuum tube, thereby providing suction from the suction tip of the lumen of the vacuum tube based on the type of tissue in contact with the suction tip. When the vacuum is generated, the suction tip will tend to indiscriminately suction any soft tissue adjacent to the opening of the vacuum tube, as long as the opening is sufficiently blocked by tissue to establish a vacuum seal. Therefore, the vacuum generated when the vacuum tube is advanced may undesirably suction tissue other than the left atrial appendage (e.g., pericardium, adipose tissue). The target tissue (1718) can be pulled toward the vacuum tube and / or the vacuum tube can be pulled toward the target tissue, and the target tissue can be releasably coupled to the suction tip of the vacuum tube at a contact position. The negative pressure applied to the target tissue by the vacuum tube can keep the target tissue in an appropriate position relative to the vacuum tube (1718). The desired contact position can be selected to cause the snare ring assembly to be properly positioned relative to the target tissue, thereby achieving closure of the target tissue. The contrast fluid device can provide the ability to visualize the target tissue to identify the desired contact position and place the vacuum tube at the desired contact position. It should be understood that in some variations, the vacuum tube can use a combination of negative pressure and the use of mechanical force (e.g., a gripping element) to contact and stabilize the target tissue, while in other variations, the vacuum tube can use only mechanical force to contact and stabilize the target tissue. A suction force can be applied through the vacuum tube to hold the vacuum tube and the angiography tube and the closure device relative to the myocardium (e.g., the left atrial appendage). The snare ring assembly and the elongated body can be advanced toward the apex of the left atrial appendage.

[0315] Fig.43D4340 is an illustrative graph of electrocardiogram signals received from a closure device (4342) and a surface ECG electrode (4344) when the suction cup is attached to the LAA and suction is applied. A relatively large value of the downward deflection of the closure device signal (4342) corresponds to an atrial signal, which can indicate that cardiac tissue is being suctioned and attached to the distal end of the vacuum tube. For example, an increase in the downward deflection between the non-suction signal (4332) and the suction signal (4342) (e.g., greater than about 0.3 mV) can indicate that cardiac tissue is attached to the device. The downward deflection can be aligned with an atrial signal (e.g., a P wave) from the surface ECG electrode. The terminal aspect of the electrocardiogram corresponds to a QRS complex from the surface ECG electrode and represents a ventricular signal. In some variations, suction can be released to reposition the vacuum cup and closure device. Fig.43E is an illustrative graph (4350) of an electrocardiogram signal received from a closure device (4352) and from a surface ECG electrode (4354). Again, the relatively large magnitude downward deflection of the signal (4352) preceding the Q wave in the ECG electrode signal (4354) corresponds to an atrial signal, which may indicate that cardiac tissue is being drawn into the vacuum tube. Fig.43F is an illustrative graph (4362) of an electrocardiogram signal received from a closure device and from a surface ECG electrode (4364). Once the snare is closed, the magnitude of the electrocardiogram may appear to decrease (e.g., signal loss), which may correspond to the onset of a P wave in the surface ECG signal. This may correspond to a loss of electrical activity at the site of the closure device and closure of the LAA.

[0316] Once the vacuum tube and the contrast tube are positioned...

Claims

1. A device for closing a target tissue, the device comprising: an elongated body comprising a first lumen extending therethrough; a snare loop assembly comprising a snare and a suture loop releasably coupled to the snare, wherein the snare loop assembly extends at least partially from a distal end of the elongated body; a vacuum tube configured to apply a vacuum to the target tissue through a second lumen passing through the vacuum tube, wherein the vacuum tube includes a suction tip at a distal end of the vacuum tube; and a contrast tube configured to inject a fluid through a third lumen through the contrast tube, wherein the vacuum tube and the contrast tube are slidably positioned within the first lumen to extend through the snare ring assembly, wherein the contrast tube includes an injection tip at a distal end of the contrast tube, wherein the injection tip is coaxial and concentric with the aspiration tip, wherein the injection tip comprises radial holes circumferentially arranged in the side wall of the injection tip, wherein the injection tip is fluidically coupled to the third lumen, wherein the injection tip is fixed relative to the aspiration tip, wherein the injection tip comprises an annular hole at the distal end of the injection tip, wherein the outer diameter of the injection tip is greater than the outer diameter of the aspiration tip such that the annular hole extends to the distal end of the aspiration tip.

2. The device of claim 1, wherein the distal end of the third lumen is proximal to the distal end of the second lumen.

3. The device of claim 1, wherein a distal end of the second lumen located within a distal end of the third lumen defines an annular aperture of the third lumen.

4. The device of claim 2, wherein the distal end of the third lumen defines a plurality of radial holes.

5. The device according to claim 1, wherein the contrast tube is coaxial and concentric with the vacuum tube.

6. The apparatus of claim 1, wherein one or more of the elongated body and the vacuum tube comprises one or more electrodes configured to receive electrocardiogram signals.

7. The device of claim 1, wherein the device is configured to generate negative pressure through the vacuum tube.

8. The device of claim 1, further comprising a vacuum pump operably connected to the second lumen and configured to provide suction at a distal end of the second lumen.

9. The device of claim 1, wherein the device comprises a handle coupled to the elongated body, the vacuum tube, and the contrast tube, the handle comprising one or more of a snare control, a vacuum tube control, a contrast control, and a vacuum control.

10. The device of claim 1, further comprising a sheath comprising a fourth lumen, wherein the elongated body is slidably positionable within the fourth lumen.

11. The device of claim 1, wherein the distal end of the elongated body comprises a suture loop severing assembly configured to separate the suture loop from the elongated body.

12. The device of claim 1, wherein the distal end of the vacuum tube comprises a balloon, wherein the balloon defines a fourth lumen operatively coupled to the second lumen.

13. The device of claim 1, further comprising a sliding fastener coupling the elongated body to the vacuum tube and the contrast tube.

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