Devices for closing the left atrial appendage

[0001] Basically, the devices, systems and methods described herein are used to close a portion of tissue, e.g., left atrial appendage, using a surgical, minimally invasive or intravascular procedure. [0002] Atrial fibrillation is a common problem affecting millions of patients. Unfortunately, atrial fibrillation often results in the formation of blood clots or clots in the left atrial appendix. This is a problem, all the more so that the clot can move and contribute to blockages in distant organs, resulting in adverse events such as stroke. For this reason, most patients with atrial fibrillation are treated with blood thinners to prevent blood clotting. However, blood thinners pose some health risks (e.g. bleeding), especially in the elderly, and often require significant changes in the user's lifestyles.

[0003] A number of methods have been developed to deal with the potential problem of clot formation in the left atrial appendage. One such method is stitching along the base or neck at the mouth of the eye, where it connects to the chamber of the atrium. In this way, the blood flow to the atrium ear is cut off, eliminating the risk of a clot forming in it. This is typically done through open-heart surgery, which makes this procedure available only to people who are undergoing open-heart surgery or at-risk individuals. In addition, open heart surgery requires general anesthesia and involves several well-known risks, which makes it less desirable.

[0004] Other methods have also been analyzed. For example, methods of automatically stitching the ear base and other methods, such as methods of filling the ear with a space occupying member or plugging have been studied. However, automatic stapling is not the preferred method, given the brittleness of the eye and the likelihood of it being broken. Closing devices may not always effectively prevent blood flow to the inside of the ear, leaving areas of potential clot formation.

[0005] Document EP-A-1010397 describes an endoscopic instrument with a thread loop at the leading end that forms the closing node when pulled by the rear end. The thread fastening units are located at the inner periphery of the spring forks to cause loose thread retention. The thread loop is fed through a sleeve in one arm of the fork. Each clamping unit has clamping ridges designed for clamping the thread loop at this point. The fork is made of a plastic material that bends easily.

[0006] In contrast, EP-A-1685802 describes a medical tool equipped with an elastic elongated material for performing a specific procedure for biological tissue and an elongated material holding member for holding this elongated material. An elastic first sheath was used to contact the base end of the elongated material holding member and a flexible second sheath, freely retractable and retracted relative to the first sheath and the elongated material holding member. An operator was used to extend and retract the second cover together with the cutting member to cut the elongated material. The cutting member is equipped with a first cutting part applied to the elongated material holding member, and a second cutting part applied for 1

ΕΡ 2 574 287 Β1 the front end of the second guard, which together with the first cutting part grip the elongated material between them. In addition, one of these cutting parts, first or second, constitutes the blade.

[0007] However, additional devices and methods for closing the left atrial tab would be desirable. More specifically, devices and methods for closing the left atrial appendage using minimally invasive, intravascular or combinations thereof would be desirable to avoid the need to open the chest. Of course, additional devices for use in open surgical procedures are also desirable, especially when these devices provide additional advantages over standard devices.

Brief Summary [0008] In accordance with the present invention, a device for closing the left atrium tab has been developed having the features set out in claim 1.

[0009] In addition, devices, systems and methods for closing the left atrial tab are described herein. Some of the methods described herein utilize one or more introducer members having leveling members to assist in positioning the closing device. Essentially, these methods include moving the first guide forward having a first alignment member to the left atrial tab, moving the second guide forward having a second alignment member to the pericardial space, aligning the first and second alignment members, activating the left atrium closure device and inserting it to the pericardial space and in the vicinity of the left atrial appendix, and closing the left atrium tab with this closing device.

[0010] The devices used in any of the methods described herein can be moved using any of a variety of visualization techniques, e.g., fiuoroscopic, ultrasonic visualization, etc. For example, the first guide, the second guide, or both guides can be moved using the fiuoroscopic visualization in some varieties. Similarly, any of the devices used in any of the methods described therein may be moved over the guide member or guide wire. For example, the first guide, the second guide, the closing device, any additional guide or any combination thereof can be moved using a guide wire. In some embodiments, the second guide is coupled to the closing device by at least part of the method.

[0011] The leveling members may be or comprise any suitable leveling member. For example, they may be or include magnets, contrast markers, echogenic markers, members configured to generate one or more audible signals, members interconnecting or interlocking, one or more vacuum members or the like. In some variants, the leveling members are magnets.

[0012] The first guide may further include an expandable member, e.g., an extendable cage, an expandable retaining structure, an expandable balloon, or the like. In some embodiments, such an expandable member comprises an expandable balloon. This expandable member may be used for any suitable purpose, e.g., atraumatic tissue displacement, to assist in identifying, dimensioning, securing, isolating, stabilizing or positioning tissue or the like. In some embodiments, the expandable member is dilated inside the left atrial appendix. In other variations of the methods described herein, the third guide moves to the inside of the left atrial lug, at 2

ΕΡ 2,574 287 czym1 wherein the third guide has a proximal end and a distal end, and also includes an expandable member. In other additional variants, the first and third guides are coupled to each other by at least part of the method. Again, in this case, the swellable member may be an evidence of a swellable member suitable for this purpose. In some embodiments, the expandable member is a balloon, which may optionally have one or more holes made therein. The holes may, for example, be useful to allow the balloon to be filled and emptied, it may be useful to allow it to pass one or more guides or guide wires, or it may be useful to allow the supply of fluids such as saline, contrast, drugs, etc. away from the balloon. [0013] The closing element can independently grip and release the left atrium tab (i.e., it can open and close around the left atrium tab), which may assist in optimal closing of the left atrium tab before it is permanently turned off.

[0014] The methods described herein may further include tensioning the seam. These methods may further include releasing the seam tension, e.g. to facilitate re-positioning of the device and the like. These methods may further include releasing the seam from the closing member, tensioning the seam, as well as cutting the seam. When the methods involve cutting the seam, the seam may be cut in a suitable way. For example, it can be cut off by a cutting element or it can be cut off by applying energy (e.g. light energy, heat energy, RF energy, electricity, magnetic energy, eIromagnetic energy, kinetic energy; chemical energy and combinations thereof ). When a cutting element is used, it may be an element of the closing device itself, or it may be part of a separate device. [0015] The methods described herein may also include confirming satisfactory or optimal occlusion of the left atrial appendix before its permanent exclusion or the opening of the left atrium appendix by means of a closing device, adjustment of the closing device, resealing of the left atrium appendix, as well as permanent excision of the left atrium appendix.

[0016] Other methods of closing the left atrial tab have also been described. In these methods, the closure device moves forward into the pericardial space and adjacent to the left atrial appendage, the left atrium appendix is ​​closed with the use of the closing device, the left atrium appendix is ​​attached with a suture, and then the suture is cut off.

[0017] As with the methods described above, the seam may be cut off in any suitable manner. For example, the seam can be cut off by means of a cutting element or by the use of energy (e.g. light energy, thermal energy RF energy, electricity, magnetic energy, electromagnetic energy, kinetic energy, chemical energy and combinations thereof). If a cutting element is used, it may be part of the closing device itself, or it may be part of a separate device, or a combination of both may be used.

[0018] The closing device may comprise one or more expandable elements, as well as the closing device, a seam, or both may contain contrast material, echogenic material or some combination thereof. In some variants, the closing device is made of a material having shape memory (e.g., a nickel-titanium alloy or the like), while in some variants, the seam is engaged with the closing device. In these methods, the closing device may be

52 574 287 Β1 visualized during movement, e.g. using physioscopy, ultrasound, combinations thereof, etc., and may also be optionally moved along a guide effect or guide wire. [0019] Additional methods of closing the left atrium tab are also described herein. These methods typically involve moving the first guide forward having a proximal end and a distal end into the left atrium tab, through the left atrium tab, and also outside the left atrium tab, such that one of the proximal or distal end is within the vascular system, as well as one of the proximal or distal end is located inside the subcostal space, as well as moving the left atrial appendage forwards into the pericardial space and adjacent the left atrial appendage, as well as closing the left atrial appendage by means of the closing device.

[0020] In these methods, the proximal end of the first guide may be inside the vascular system, or inside the rib cage. In some embodiments, the closing device moves into the pericardial space after the first guide. Again, as with the methods described herein, any of the devices can be moved using any of a variety of visualization techniques. For example, the first guide, closing device, or both can be moved using fluoroscopic or ultrasonic visualization, or both. In some embodiments, the methods further include moving the second guide forward into the left atrium tab, the second guide having a proximal end, a distal end, and also comprising. The expandable member may be any suitable expandable member (e.g. elongated rods, expandable cage, expandable balloon or the like). In some embodiments, the first and second guides are coupled to each other by at least part of the method.

[0021] Devices for closing the left atrium tab are also described herein. The second lumen of the retaining member may have a weakened area, a perforated area or also a slot or other opening configured to release and / or close the seam by applying force. In other variants, the retaining member and the closing element are removable or otherwise removed, leaving behind and / or closing the seam loop. In yet other embodiments, the retention member includes a first lumen and one or more releasable retention members, wherein the closure member is positioned within the first lumen, while the seam loop is retained by one or more releasable retention members. The retention element may be any suitable element for this purpose, e.g. releasable projection, polymeric stud and the like.

[0022] The closing element can be made of any suitable material. In some embodiments, the closing member may be made of a material having shape memory (e.g., nickel titanium alloy). Similarly, the seam loop can be made of any suitable material (e.g. any suitable material for exclusion or closure). It can be bio-absorbable (e.g. biodegradable polymers, etc.), or non-bio-absorbable (e.g. non-biodegradable polymers, metals, etc.). The closure member, seam loop or both may contain contrast material or echogenic material.

[0023] In some embodiments, the elongated body has one or more curvatures along its length. The elongated body may optionally be controllable and may also optionally be configured as

ΕΡ2 574 287 Β1 catheter In some variants, the closing element and the seam loop can be operated separately. In other variants, the device further includes a cutting element.

[0024] Systems for closing the left atrial appendage are also described herein. Typically, such arrangements include a first guide having a size and length adapted to gain access to the left atrial appendage through the circulatory system, the first guide having a first leveling member, a second guide having a size and length adapted to access the pericardial space from the subcostal area , the second guide comprising a second leveling member and also a closing device as previously described. The system may further include any suitable or useful device or component.

[0025] For example, in some embodiments, the system further includes an expandable member. The swellable member may be any swellable member suitable for this purpose, and in some embodiments, the swellable member is an expandable balloon optionally with one or more holes. The swellable member may be configured to engage the first guide.

[0026] The systems described herein may further include a seam cutting device or element. In some variants, the closing device may be coupled to the second guide.

[0027] The first and second leveling members may be any suitable leveling members. For example, they may be or include magnets, contrast markers, echogenic marker materials, members configured to generate one or more audible signals, interconnecting or blocking members, one or more vacuum members, or the like. In some embodiments, the leveling elements are magnets that may or may not be located at the distal ends of the first and second guides. These systems may further include instructions for using the first guide, second guide, closing device, or any combination thereof. In some embodiments, the longitudinal body of the closing device has one or more curvatures along its length, and these systems further include a straightening tube configured to temporarily straighten the one or more curves.

Brief description of the drawings [0028]

Fig. 1 is a cross-sectional view of the heart showing various anatomical structures.

Figures 2A-2B are different views of an illustrative device that can be used with the systems and methods described herein.

Fig. 3A is an enlarged view of the distal end of the illustration device having the retaining member.

Figures 3B-3D show illustrative stop members that can be used with the devices described herein.

Fig. 4 is an enlarged view of the distal end of the illustration device without the retaining member.

Fig. 5 is a view of the illustrative device with the catheter body removed for descriptive reasons and for the clarity of the message.

Fig. 6 is another view of the illustrative device with the catheter body removed, with most of the device shown here.

ΕΡ 2 574 287 Β1

Fig. 7 is an enlarged view of the illustrative seam retention mechanism, herein shown as a seam hook.

Fig. 8 is an enlarged view of the distal end of the illustration device having a passing clearance through it.

Fig. 9 is a side view from above of one of the variants of the proximal end of the devices described herein.

Fig. 10 is an oblique view from the end of one of the variants of the proximal end of the devices described herein.

Fig. 11 shows a cross-sectional view of one of the variants proximal end of the devices described herein.

Fig. 12 is an illustrative seam cutter that can be used with the systems and methods described herein.

Figures 13A and 13B show illustrative guides having leveling members.

Figures 14A-14D illustrate an illustrative method of closing the left atrium tab.

Figs. 15A-15D show an alternative, illustrative method of closing the left atrium tab.

Fig. 15E illustrates an illustrative device that can be used to perform the method illustrated in Figs. 15A-15D.

Detailed description [0029] Devices, systems and methods for closing the left atrial appendage are described herein. In this regard, it can be helpful to start by briefly defining and describing the appropriate heart anatomy. Fig. 1 is a cross-sectional view of the heart (100). The frontal vestibule (102) and left ventricle (104) of the heart are shown here. Between the left atrium (102) and the left ventricle (104) of the heart is a mitrain valve (also known as a mitral valve), which is determined by a pair of petals (106) of the mitral valve. These petals are connected to the pseudo-tendon strings (108), which are in turn connected to the papillary muscles (110). Papillary muscles attach to the wall (112) of the chamber. The left atrial appendix (114) is depicted adjacent to and formed from the left atrium wall (102).

[0030] As can be seen, the left atrial appendage (114) rests within the pericardial boundaries (116), and is also in close proximity to the wall (112) of the heart chamber. The left atrial appendix typically has a tubular shape, similar to conical, with a slight narrowing or neck in the plane of the outlet opening, where it connects with the left atrium (102). In patients with atrial fibrillation, the left atrial appendage (114) is the most common site for the formation of blood clots, which over time can move and cause destructive stroke. Because stroke is a major complication of atrial fibrillation, the left atrial appendage is often excited from the left atrium in patients undergoing atrial fibrillation treatment procedures, and is also often removed or excused during other surgical procedures such as surgery mitral valve to reduce the risk of stroke in the future. The devices and systems described herein help to ensure the correct closing of the left atrium, at the neck or base of the left atrium, along the anatomical plane of the mouth. In this way, the excision of the entire left atrial lobe from body circulation can be facilitated.

I. Devices [0031] The devices for closing the left atrium tab essentially comprise a closing element having one or more loops. These devices may be suitable for use with minimally invasive access to the left atrium appendix (e.g. through a small incision of the changeling6

ΕΡ2 574 287 Β1 cotton wool or other intercostal incision, through the incision in the rib cartilage, through the port, through the circulatory system, etc.) or may be suitable for use with open surgical procedures. The length of devices can be selected according to the needs.

[0032] Figs. 2A and 2B show different views of an exemplary device that can be used to close the left atrium tab. Fig. 2A shows a device (200) comprising an elongated body (202) having a proximal end and a distal end, as well as a closing element (204). In this variant, the closing element comprises a loop that defines a continuous opening extending through it, suitable for surrounding the left atrial appendage. The closing element is at least partially positioned inside the elongated body (202) and can be pulled out or withdrawn from it. Fig. 2A also shows a clearance (214) for passing tools or fluids through it. For example, the lumen (214) may allow guiding (with or without an alignment member), guide wire, seam cutting element, fluids and / or drugs and the like. Any number of lumens can be used for any purpose. The respective clearances will be described again with reference to Fig. 8. Figs. 2A and 2B also show a handle (206) having a linear actuating slide (208) and a knob (210). Additional handle details will be discussed below. [0033] In the variant shown in Fig. 2A and 2B, the elongated body (202) includes a curvature (212) at its distal part, In cases where the longitudinal body (202) of the device contains one or two curves, a straightening tube or other straightening mandrel or mechanism can be used for temporary straightening elongated body during delivery (e.g., until it reaches the pericardial space). After reaching a certain position, the straightening tube or mandrel can be led out. The straightening tube can be made of any suitable material (e.g. rigid plastic, stainless steel, combinations thereof, etc.). Of course, it should be understood that this device need not contain one or more curvatures as shown in Figs. 2A and 2B. For example, the elongated body may be straight and flexible, and the pre-curved tube or mandrel may be used when performing methods to assist in feeding and use (e.g. when moving to the left atrium). Similarly, the elongated body can be straight and flexible, and also has a pull wire attached thereto, so that when the pull wire is pulled in the proximal direction, the elongated body swings flexibly and bends. In this variant, the elongated body can be maneuvered as needed. It should be understood that any of the devices described herein may be configured to allow control and may also be configured for robotic use (e.g., configured for use with one or more robotic devices or other types of automated devices).

[0034] Fig. 3A shows an additional detail of the respective closing element. The distal part (300) of the respective closing device having the elongated body (302) and the closing element assembly (304) is shown here. In Fig. 3A, details of the longitudinal body or tip (306) can be seen. This tip can be thermoformed or injection molded, or it can be integral with the rest of the elongated body (302). In cases where the seam loop (308) is used, the tip (306) may be used to place inside the seam node. It should be understood that when reference is made to the elongated body, this means that any such tip (306) as shown in Fig. 3A is included. Also visible in Fig. 3A is the loop (308) of the seam, which is shown as passing through the tip (306) in a direction closer to the stopping member (312) in the direction of

52 574 287 Β1 farther, Also shown is the closing element (310) as passing through the tip (306) in a closer direction and into the inside of the stopping member (312) in a distal direction that will form a loop around the left atrial appendage. As can be seen from Fig. 3A, the retaining member is configured to retain the closing member and the seam loop.

[0035] Figures 3B-3D show illustrative stop members that can be used with the devices described herein. Fig. 3B is an end view of the retaining member (314) having the first and second lumen (316, 318) for retaining the closing member and the seam loop inside. In this variant, the second lumen (318) has a slit or other opening (320) along its length to allow the seam to pass through it when it is ready for use. Of course, it should be understood that the first and second lumens may be positioned or oriented relative to each other in any suitable manner, and similarly, the tub gap other opening in the second lumen may be positioned or oriented in any suitable manner relative to the first lumen (e.g. it may be an angle of 180 °, approximately 150 °, approximately 120 °, approximately 90 °, approximately 60 °, approximately 30 °, or the like, relative to the first clearance (316)). Fig. 3C is an illustration of a retaining member having a first lumen (322), a second lumen (324), and a slit (326). In this variant, the gap (326) is located closer to the first lumen (322) than the gap according to Fig. 3B. The width or distance of the gap opening can be selected to suit your wishes or needs. Similarly, the gap need not extend or be continuous along the entire length of the retaining member. In some embodiments, the slots may have protrusions or arms along their length to assist in capturing and retaining the seam in them. In other variants, the gaps can be covered in places spaced along the gaps with a biodegradable polymer, temporarily used to attach or press the seam. Of course, in yet other embodiments, the retention member does not include a gap, and instead includes some kind of retention mechanism, such as the projections or studs described above. In yet other variants, there are no slots or openings in the retaining member, and the seam loop is released when the retaining member is removed or retracted and the device is closed.

[0036] Fig. 3D shows another variant of the retaining member. In this variant, the retaining member has a first lumen (328), a second lumen (330), and a separation area (332). This separation area can be constructed in any suitable way. For example, the separation area may comprise a perforated area adapted to perforate and release the seam by applying a force. Alternatively, the separation area may have a thin wall or other weakened area that can be configured to break and release the seam. It should be understood that the retaining member may have any suitable geometry or shape, and may be made of any suitable material. Similarly, the clearances do not have to be solid circles or have circular cross-sectional geometry. When these or other types of retention members are used, the seam loop may be detached, stretched, or otherwise released from the retention member after it has been properly positioned and drawn as required, [0037] The above described components may be made from any suitable material for this purpose. For example, the closure member may be made of a shape memory material, such as a shape memory alloy (e.g., nickel titanium etc.), stainless steel, polyester, nyl

52 574 287 Β1 nu, polyethylene, polypropylene, some combinations thereof etc. Similarly, the seam loop may be made of any suitable material suitable for this purpose, which is suitable for exclusion or sealing, and the term "seam loop" should be properly understood. For example , it can be made of biodegradable material (e.g. poly (lactic acid), poly (glycolic acid), copolymer of lactic acid and glycolic acid, etc.), or it can be made of non-biodegradable material (e.g. metal, steel, polyester, nylon, propylene, silk and combinations thereof) . In some embodiments, as will be described in more detail below with reference to the methods, the seam loop is made of biodegradable material, such that this seam loop degrades after a certain period of time (e.g. such that sufficient scarring can be obtained), It should be understood that any part of the device may contain, be composed of, or made of a contrasting or signal generating material to assist in facilitating visualization. For example, the closure element, seam loop, elongated body, or any combination of these elements may contain contrasting or echogenic material.

[0038] The seam loop and closing member may be configured to have any suitable circumference. For example, they may have a circumference of 114.3 mm (4.5 inches) in the fully expanded state, a circumference of about 109.2 mm (about 4.3 inches), about 83.8 mm (about 3.3 inches), about 101.6 mm (about 4.0 inches), about 88.9 mm (about 3.5 inches), 76.2 mm (3.0 inches), about 68.6 mm (about 2.7 inches), about 63.5 mm (about 2.5 inches), about 38.1 mm (about 1.5 inches), about 31.8 mm (about 1.25 inches) or the like. Of course, these circuits can be different as the closing member and the seam loop are actuated and retracted.

[0039] For further explanation, Fig. 4 shows a view of the distal portion (300) of Fig. 3A, without the retaining member (312), and thus shows the loop character of the closing element (310) and seam (308). Fig. 5 is a view of the distal portion (300), without the retaining member (312), the tip (306), as well as the elongated body (302), illustrating additional details of this device variant. Of course, the closing element (310) and the seam (308) are shown here. The suture (308) further includes a surgical node (i.e., e.g. a one-sided clamping node or other appropriate node) (500). There is also shown an anchoring element (502), here illustrated as a tube, for anchoring one side of the closing element (310). The opposite side of the closing element is the active or actuating side (i.e. one side remains anchored while the other side has an additional active section). Of course, when anchoring is used, it may be carried out in any suitable manner. In other variants (not illustrated here), both sides of the closing element are active and operable (i.e. no side is anchored). The device may also include a seam tube (504) to facilitate passing the seam.

[0040] Fig. 6 shows an additional closer detail of the respective closing device. In this view, the elongated body and tip have been removed, but the retaining member remains. The hook (600) for the seam is particularly interesting here. The hook (600) for the seam catches the seam loop (308) in such a way that the closing element (310) can be moved forward and retracted separately from the seam loop (308) when they are engaged with each other. This means that the hook (600) for the seam prevents the seam from tightening when the closing element is activated, so that the device can be positioned as needed before the seam is started. The hook (600) for the seam can also prevent the excess seam from opening and closing, and thus prevent the excess seam from hooking on anatomical structures, instruments, etc. Fig. 6 also shows the closer section of the closing element (602). In some

5 2,574 287 Β1 variants, it may be useful to use at least a portion of the proximal section of the closing member (602) coated with a lubricating coating to assist in facilitating sliding actuation. Any suitable lubricating coating (e.g. PTFE etc.) may be used. The hook (600) for the seam is shown in more detail in Fig. 7. However, the hook for the seam in Fig. 7 has a rounded atraumatic tip, however, need not be so. In fact, any suitable tip can be used. The seam hook can be made of any suitable material.

[0041] Fig. 8 shows details of a distal part of the illustrative closing device (800), here comprising at least one lumen (802) in the elongated body (804). The ground clearance can be used for any suitable purpose. For example, it may be used to allow one or more guides or guide wires, one or more tools or the like to pass through it. The lumen can also be used as a flow lumen, vacuum lumen, bow delivery lumen or the like. The elongated body may contain any number of lumens, and it should also be understood that the lumens do not need to pass the entire length of the elongated body, nor do they have to form a completely restricted opening (i.e. the use of clearances here is intended to cover cases in which the gap or groove may be used with one or more guides, guide wires or additional tools).

[0042] Fig. 9 shows one variant of the respective handle (900) for the devices described in this document. In this variant, the handle includes a linear actuating slider (902) for actuating the closing member, as well as a seam knob (904) for actuating the seam. However this is not shown, the above described hook for the seam or similar supports the possibility of obtaining separate actuation capability as described herein. Thus, when the slider (902) is pushed distally, then the closing member, which was at least partially held within the elongated body, will be moved rearward and the loop size of the closing member will increase. Otherwise, when the slide is retracted in the proximal direction, the closing element will be retracted, while the loop size will decrease. The seam loop will not change as a result of this process. Instead, the seam loop in this variant is controlled by the seam knob. Of course, the seam loop does not have to be activated with the knob. This means that the seam can be actuated separately by an additional slider, lever, button or the like. Similarly, the closing element need not be actuated by the slider. It can be activated by a button, knob, lever or the like.

[0043] Fig. 9 also shows a gap (906) intersecting the seam. Although it is not easy to see in this view, the seam runs through the handle and the knob. The seam-cutting gap allows easy seam cutting when the seam passes through the gap transversely and the gap provides an inspection window and access point for seam cutting. Of course, the seam does not have to be cut off in this way. In some variants, the closing device itself includes a cutting element for cutting the seam (e.g., a blade operated by a button or some other mechanism). Fig. 10 shows an oblique rear view of the handle shown in Fig. 9 in such a way that additional details can be seen. More specifically, the lock (1000) of the seam knob and Luer connector (1002) are shown at the proximal end of the handle lumen.

52 574 287 Β1 [0044] Fig. 11 is a cross-sectional view of a portion of the handle (1100), here showing the handle section including the knob (1102) of the seam and the sliding actuator (1104) in its furthest retracted position. The seam knob (1102) includes the outer knob (1106), as well as the outer knob bracket (1108), inner knob (1110) and inner knob bracket (1112), the thrust bearing (1114), and the slip plate (1116) that when activated (when the knob (1102) is turned or rotated), the seam loop is tensioned, causing it to be released from the retaining member. In one variant, the slip clutch plates (1116) have special force settings and are configured to provide a tactile feedback to the operator indicating the closure. In other embodiments, the clutch plates (1116) may have a specific force limit to prevent the suture from cutting or cutting tissue when releasing or tightening the suture loop. For example, in these variants, when the seam loop reaches a predetermined force, the outer knob (1106) and the outer knob support (1108) can be decoupled from the inner knob (1110) and the inner knob (1112) by extending or doing so similar (e.g. like a gas cap after overloading).

[0045] Also shown is the seam roll area (1118) and the seam intersecting gap (1120) which, as briefly described above, is used to assist the seam finish by placing a blade, scalpel or other sharp instrument inside. As described above, in some embodiments, the closing device itself includes a seam-cutting device or mechanism that can be located in the same place as the gap (1120) intersecting the seam or in some other place. For example, the device may include a blade or other cutting mechanism that can be actuated by the blade, lever, knob, etc., regardless of whether it is positioned at the seam cutting slot. The clearance (1122) can be used to place a guide (with or without an alignment member), a guide wire or one or more tools (e.g. a seam knife, visualization devices, etc.), one or more fluids (e.g. saline, drugs, etc.) as described above.

II. Methods [0046] Methods of closing the left atrium tab are also described herein. Access to the left atrial appendage may be obtained in any suitable manner for this purpose, or any device described herein may be used. For example, access to the left atrial appendage may be obtained from inside the heart, or may be obtained from outside the heart. In some variants, access to the left atrium is obtained from both the inside and outside of the heart. Typically, the ear is cut off from the outside of the heart, even if access is gained from inside the heart.

[0047] In variants in which access to the left atrial appendage is obtained from both the inside and outside of the heart, it may be useful to use guides having alignment members. In this way, access to the left atrial appendage can be greatly facilitated. It may also be useful to use a positioning or stabilizing device to assist in positioning devices relative to the left atrial appendage and to stabilize the appendage while it is being cut off. The positioning or stabilizing device may be any stabilizing or positioning device, e.g. an expandable member or the like. More details of this issue will be described below, [0048] In some embodiments, the methods of closing the left atrial tab include moving the closing device to the pericardial space and adjacent to the left atrium tab, closing the left atrium tab by means of the closing device, securing the closed tab

5 2,574 287 Β1 left atrium with a suture, then cutting the suture. The closing device may be any suitable closing device, such as a device having an elongated body with a closing element having a loop defining a continuous opening through it, as described above. The seam can be cut in any suitable manner for this purpose, as well as in any appropriate place along its course (i.e. from the place immediately adjacent to the node at the left atrium tab to a place near or even distant from the skin surface). In some cases, it may be desirable to cut the seam at the node itself (e.g., in cases where it is desired to completely release the seam tension).

[0049] An illustrative seam cutting device (1200) is shown in Fig. 12.This illustrated device may be threaded through the seam and then actuated to cut the seam with a blade or similar intersecting element inside the distal portion (1202). However, in Fig. 12 a device having an inside blade is illustrated, however, any cutting device may be used, and this device may be made of or contain any suitable materials (e.g. contrasting or signal generating material). In some variants, the closing device has a cutting element on it to cut the seam. Of course, the seam does not have to be cut off with a blade or other such cutting element. The seam can be cut off by applying energy. For example, the seam may be cut by applying light energy, heat energy, radio frequency energy, electricity, magnetic energy, electromagnetic energy, kinetic energy, chemical energy, and a combination of any of the above. Additional methods will be described below.

A. Access through the septum and pericardium [0060] In some embodiments, methods of closing the left atrial appendage include accessing the left atrium appendage both from inside the heart and from the outside of the heart. In these variants, one or more guides having leveling members are often used to align the internal and external access devices. To gain access to the inside of the heart, a circulatory system is typically used. For example, access can be obtained through one or more different veins or arteries (zygomatic, femoral, jugular etc.). In some embodiments, access to the heart is obtained via the femoral vein (e.g., left femoral vein) using a standard Seldinger technique with a needle. Then the introductory wire can be guided forward through the needle followed by the introducer sheath. The introductory wire can then be removed. In some embodiments, a guide catheter sheath may be provided as an alternative to the introductory sheath or the initial sheath may be replaced by a guide catheter sheath.

[0051] The use of fiuoroscopy, angiogram performed by the sheath, catheter placed through the sheath, guiding the catheter sheath, or any combination thereof, can be included to observe anatomical characteristics and consider the access path for access through the left atrium septum (e.g., tortuous course, blood clots, devices such as main vein filters, etc.). Ffuoroscopy, ultrasound, internal cardiac echocardiography, external cardiac echocardiography, or combinations thereof, can be used to assist in visualizing access to the left atrium through the septum, and access to the left atrium can be obtained using standard partition access techniques.

52 574 287 Β1 [0052] For external cardiac access needs, an anti-rib access point may be used. This access point is typically determined based on the patient's anatomical characteristics. In some variants, the access point is located to the right of the xiphoid process and faces the left shoulder blade of the patient, the sword may be in any suitable place (e.g. intercostal access via sternotomy or thoracotomy or also in the rib cartilage itself). Once the access point has been defined, the needle (e.g., 17G Tuohy needle) can be moved forward using standard pericardiocentesis techniques with fiuoroscopic guidance. After gaining access to the pericardium, the guide wire can be moved forward through the needle, using fluoroscopic visualization inside the pericardial sac, and the needle can then be removed. This way you can access the pericardial space.

[0053] Returning now to the figures, having been accessed from the inside and outside of the heart, using the devices and techniques described above, the devices are ready for use. For example, the first (1300) and second (1302) guides having alignment members as shown in Figs. 13A and 13B, respectively, may be used to conduct this procedure. The leveling member may be any suitable leveling member (e.g. interconnecting elements, one or more vacuum elements, marker contrast or signal generating materials, members which are configured to produce an audible response, magnets, etc.). Here, the leveling members are magnets (1304, 1306) located at the distal ends of the guides. Magnets can be made of or contain any suitable magnetic material, e.g. a rare earth magnet such as neodymium iron boron, cobalt samarium or other strong solid magnetic elements. These guides can be used to guide additional tools and / or devices to the left atrium tab. [0054] The guides may have any suitable lengths and / or dimensions. For example, the guides may have a diameter of about 0.254 mm to about 1.270 mm (about 0.010 inches to about 0.050 whole), about 0.508 mm to about 0.762 mm (about 0.020 inches to about 0.030 inches) and the like. In some embodiments, the first guide has a diameter of about 0.635 mm (about 0.025 inches), while the second guide has a diameter of about 0.889 mm (about 0.035 inches). Similarly, the length can be any suitable length. For example, from about 50 cm to about 300 cm or more, from about 100 cm to about 200 cm, from about 200 cm to about 250 cm, and the like. In some embodiments, the first guide has a length of about 250 cm, while the second guide has a length of about 90 cm. The outer diameter of the leveling element can be selected as required. For example, it may be from about 1.27 mm to about 5.08 mm (about 0.05 inches to about 0.2 inches) or more. In some embodiments, the outer diameter of the first guide leveling member is about 2.692 mm (about 0.106 inch), while the outer diameter of the second guide leveling member is about 4.318 mm (about 0.170 caia). It should be understood that these dimensions are suitable for any guide, not just dfa guides having alignment members containing one or more magnets.

[0055] For example, returning to Fig. 14A, the first guide (1400) can be guided forward to the left atrial appendage (1404), while the second guide (1402) can be moved forward to the pericardial space adjacent to the left atrial appendix . Each of these guides can be moved forward using various visualization techniques, e.g. fiuoroscopic visualization, ultrasonic visualization, some combinations thereof, etc. Balloon catheter (1406) or other 13

ΕΡ 2 574 287 Β1 the expandable member may be moved forward along the first guide, or in combination with the first guide (e.g. it may be engaged or be part of the first guide) and into the left atrium tab, as shown in Fig. 14B, Similarly, the closing device (1408) can be moved forward along the second guide or in combination with the second guide (e.g. it may be engaged or be part of a second guide) as shown in Fig. 14B.

[0056] In cases where the balloon is used as an expandable member, it may be made of any suitable material. For example, it may be made of polyisoprene or other suitable materials. Similarly, the balloon can have any suitable dimensions. For example, it may have an outer diameter of approximately 10-40 mm, approximately 20-30 mm or the like. Similarly, it can be of any suitable length. For example, it may have a length of about 5 mm to about 50 mm, about 10 mm to about 20 mm, or the like. In some embodiments, the balloon has an outer diameter of approximately 20-30 mm and a length of about 20 mm.

[0057] The swellable member (in this variant, shown as an swellable balloon) is inflated to position and stabilize the left atrial lug, as shown in Fig. 14C. In its filled state, the expandable member helps locate the plane of the left atrium appendix. More specifically, when the expandable member is enlarged, the left atrial appendix is ​​distended, and its shape changes from roughly conical to approximately spherical, and thus the connection between the left atrium appendix and the left atrium is better marked. In addition, the expandable member in its enlarged state may be at a pressure greater than the pressure specific to the left atrium, whereby there is a significant difference in stress between the left atrial ear and the left atrium. The expandable member may have one or more holes through it to pass the contrast to facilitate visualization.

[0058] When the expandable member is still in its enlarged state, the closing member (1410) of the closing device (1408) can be placed around the left atrial lug and closed as shown in Fig. 14D. However, in some variants, the closure member is placed around the left atrial lug while the balloon is in its unfilled or enlarged state, and then the balloon is inflated. Then the seam can be led out of the device, clamped around the closed ear, released from the device and cut off, leaving the closed ear in place. Of course, in some cases it may be desirable to confirm that the ear is properly closed before tightening the seam and then again after the seam has been tightened using fluoroscopic and other visualization techniques. If the closure is not suitable or otherwise undesirable, then the loop can be opened, moved, closed and then confirmed again.

[0059] More specifically, it is desirable for the left atrium tab to be closed as close as possible to the plane of the anatomical opening (i.e., the opening that separates the left atrium from the left atrium tab). If the left atrial appendix is ​​closed above the opening plane (towards the tip of the left atrium appendix or further away from the anatomical orifice plane), this may cause permanent left atrial appendage diverticulum, which in turn may result in the creation of an additional place or nest for clot formation, despite complete left atrial ear exclusion from the left atrium. In some people, the geometry of the left atrium and the left atrial appendage may be 14

ΕΡ 2 574 287 Β1 such that the neck or narrowing between them is clearly distinguishable from epicardium or surroundings. In addition, the external geometry of the connection of the left atrial appendage and the left atrium is difficult to distinguish from the epicardium perspective. This may be aggravated by the fact that during the procedures, the anatomical parts move vigorously while the heart beats and the lungs remain filled (i.e. when the chest is closed). From the point of view of the internal or intracardiac aspect, fluoroscopy and ultrasound methods provide only limited information or the ability to find a suitable landmark in the faithful three-dimensional characteristics of the anatomical plane of the mouth. Thus, the use of the devices described herein helps facilitate the correct positioning and closing of the left atrium and can be used during procedures performed on a working heart, resulting in significant benefits over known devices for closing the left atrium.

[0060] Of course, it is possible to know variants of this method. For example, the guides can be used as guide wires or rails for additional devices that slide on them, or the guides can be coupled with the devices just described above. Additional guides or guide wires can also be used, and confirmation steps can be used wherever needed. During these methods, the guides wearing the leveling members can be used or removed as required or desired. In some embodiments, the closing device has one or more bumps or curves along its length, and then a tip straightening element or tube is used to temporarily straighten the bend as the device moves into the pericardial space. In other variants, where the device simply comprises an elongated body, a pre-bent device may be used to assist the feeding after obtaining the correct access. In some variants, the suture loop is made of biodegradable material and is configured to biodegrade after scarring or new tissue is formed, which effectively seals the ear.

B. Access through septum or pericardium [0061] In the methods described above, access to the left atrial appendage is obtained both from the inside and outside of the heart. Of course, the left atrium appendage can be closed using the systems and devices described herein, without performing both access procedures as described above. For example, in some embodiments, the methods include moving the first guide forward having a proximal end and the distal end into the left atrial appendage, through the left atrial appendage, and also outside the left atrium appendage, such that the proximal or distal ends are in the muscle tissue, while one of the proximal or distal end is located inside the subcostal space.

[0062] After gaining access in this way, the closing device can then be moved into the pericardial space and adjacent to the left atrial appendix, and the left atrium appendix is ​​closed. Of course, the proximal end of the first guide may be inside the muscle tissue, and may also be inside the subcostal space. In some variants, the closure element is moved into the pericardial space after the first guide. In other embodiments, the methods further include moving the second guide forward into the left atrium tab, the second guide comprising an expandable member. This second guide can

ΕΡ2 574 287 Β1 should be moved to the left atrial appendage after the first guide, although it does not have to be moved in this way.

[0063] Other methods of closing the left atrial appendage are also described herein, without performing both access procedures (i.e., through the septum and epicardium). Basically, these methods include accessing the inside of the left atrium of the left atrium from the epicardium, using a device that is configured to puncture the wall of the ear. The expandable member, such as a balloon, is then moved forward through this puncture inside the left atrial appendage, and inflated to assist in positioning the left atrium appendage when closing it.

[0064] Referring now to the figures, Fig. 15A shows the device (1500) closing the left atrial appendix, moved forward adjacent the left atrium appendix (1502), from the outside of the heart. This closing device can be moved forward in any suitable manner. For example, it is possible to move forward through the subcostal procedure or also through intercostal or intra-rib access, through open surgical access or the like, as described above. This closing device includes a closing element (1504) (e.g., a loop as shown in Fig. 15A) which is moved around the left atrial lug (1502) and pulled to close the lug. This device may include a blade or other intersecting mechanism (1506), and such a mechanism may be used to puncture the left atrial appendix after it has been closed, allowing access to the interior of the ear, as shown in Fig. 15B. Once access to the inside of the ear has been obtained, the expandable member (which may be part of the closing device or may be a different device intended to cooperate with the closing device) may be expanded inside the left atrium ear for positioning and as described above. The left atrial appendix can then be resealed (confirmed by visualization techniques as described above), and a suture is applied to the left atrium for permanent attachment of the left atrial appendix. The device (1500) can then be retracted in a proximal direction and the seam (1510) cut off using any of the techniques described above. An illustrative device (1512) for performing this method is shown in Fig. 15E. There is shown a device having a proximal end (1513) and distal end (1515), balloon (1514), retractable blade (1520), blade actuator (1516), and filling clearance (1518) for inflating the balloon. Of course, other suitable devices may also be used to perform this method.

III. Systems [0065] Systems for closing the left atrial appendage are also described herein. In general, these systems may include a closure device capable of performing the procedure for closing the left atrial appendage as described above, together with one or more additional components. For example, the system may include a first guide having a size and length adapted to gain access to the left atrial appendix through muscle tissue and also comprising an alignment member, a second guide having a size and length adapted to gain access through the pericardial space from the subcostal space and containing the member leveling device as well as a closing device. This leveling member may be any suitable leveling member. For example, the alignment member may contain contrast or signal generating markers, members

ΕΡ 2,574 287 Β1 configured to generate an audible response, one or more interconnecting members, one or more vacuum members or magnets. In some embodiments, the alignment members of the first and second guides include magnets, as shown in Figs. 13A and 13B, respectively.

[0066] The closing device may be any of the closing devices described above. For example, the closing device may be a device having a closing member that includes a loop defining a continuous through hole. The system may further include an expandable member or a device comprising the expandable member. Such a swellable member may be any suitable swellable member, such as, e.g., the balloon catheters described above. The expandable member may have one or more holes to allow it to provide contrast or other fluids. The system may further comprise a seam loop, and this seam loop may optionally be coupled or capable of being coupled to a closing device.

[0067] These systems may also include one or more seam cutting devices. Similarly, the systems may include one or more devices for temporarily straightening one or more curves along the longitudinal body of the closing device. Of course, this device may contain instructions for using any, all or part of the components of the system (e.g. a first guide, a second guide, a closing device, a straightening tube, a seam-crossing element or some combinations thereof).

[0068] Any of the above described devices have, for the sake of clarity and understanding, described in some detail through the illustration and example, it will be understood that certain changes and modifications may be made without departing from the scope of the appended claims.