Devices and sytems for closing the left atrial appendage

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DEVICES, SYSTEMS AND METHODS TO CLOSE THE LEFT ATRIAL APPENDIX

Cross Reference To Related Orders

The present application claims priority of US Provisional Patent Application Serial No. 60/921,002, filed March 30, 2007, which application is incorporated by reference herein in its entirety.

Field

In general, the devices, systems and methods described herein are for closing a portion of tissue, eg, the left atrial appendage, using a minimally invasive surgical intravascular approach.

Historic

Atrial fibrillation is a common problem that affects millions of patients. Unfortunately, atrial fibrillation often results in the formation of a thrombus or clot in the left atrial appendage. This presents a problem in that the thrombus can dislodge and embolize distant organs, resulting in adverse events such as a stroke. For this reason, most patients with atrial fibrillation are treated with a blood thinner to help prevent a thrombus from forming. Blood thinners, however, can pose health risks (eg, bleeding), especially in people of advanced age, and often also require the user to make significant lifestyle changes.

Several methods have been developed to address the potential problem of thrombus formation in the left atrial appendage. One method is to suture along the base or neck.

2/37 of the appendix, where it joins the atrial chamber. In this way, the flow of blood in the atrial appendages is cut, eliminating the risk of thrombus formation in them. This is typically accomplished through open-heart surgery, making the availability of the procedure available to only those who are otherwise undergoing an open-heart procedure, or who are at especially high risk. In addition, open-heart surgery requires general anesthesia and has a number of well-known risks, making it less desirable.

Other methods were also investigated. For example, methods of stapling the base of the appendix and methods were investigated, as per the methods of filling the appendix with a space-occupying or closing limb. However, stapling is not a preferred method considering the fragility of the appendix and the likelihood of its rupture. Closure devices may not effectively stop all blood flow to the appendix, leaving areas of potential thrombus formation.

Additional devices and methods to close the left atrial appendage would therefore be desirable. Especially, devices and methods for closing the left atrial appendage using a minimally invasive intravascular technique, or a combination of these techniques, would be desirable in order to avoid the need to open the chest. Clearly, additional devices for use in open surgical procedures are also desirable, especially when such devices offer additional advantages over standard devices.

Brief Summary

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Devices, systems, and methods for closing the left atrial appendage are described here. Some of the methods described herein utilize one or more guide members having alignment members to assist in positioning a closure device. Generally, these methods comprise advancing a first guide having a first alignment member in the left atrial appendage, advancing a second guide having a second alignment member, into the pericardial space, aligning the first and second alignment members , advancement of a left atrial appendage closure device into the pericardial space adjacent to the left atrial appendage, and closure of the left atrial appendage with the closure device. In such variations, the closure device typically comprises an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closing element comprises a complete turn defining a continuous passage therethrough.

Any of the devices used in any of the methods described herein may be advanced under any variety of visualization techniques, eg, fluoroscopic visualization, ultrasound, etc. For example, the first guide, second guide, or both guides may be advanced under fluoroscopic visualization in some variations. Similarly, any of the devices used in any of the methods described herein may be advanced over a guide element or guide wire. For example, the first guide, second guide, closure device, any additional guide or any combination thereof, may be advanced over a guide wire. In some

In variations, the second guide is coupled to the closure device for at least a portion of the method.

The alignment members may be, or may comprise, any suitable alignment member. For example, they may be or may comprise magnets, radiopaque labels, echogenic labels, members configured to produce one or more audible signals, interconnecting or interlocking members, one or more vacuum members, or the like. In some variations, the alignment members are magnets.

The first guide may further comprise an expandable member, e.g., an expandable cage, an expandable support structure, an expandable balloon, or the like. In several variations, the expandable member comprises an expandable balloon. The expandable member may be used for any suitable purpose, eg, to traumalessly displace tissue, assist in tissue identification, size, protection, isolation, stabilization or positioning, or the like. In some variations, the expandable limb is expanded into the left atrial appendage. In other variations of the methods described herein, a third guide is advanced into the left atrial appendage, wherein the third guide has a proximal end and a distal end and comprises an expandable member. In some additional variations, the first and third guides are coupled together for at least a portion of the method. Again, the expandable member may comprise any suitable expandable member. In some variations, the expandable member is a balloon, which may have one or more passages therein. Passages, for example, can be useful in allowing

5/37 balloon inflation and deflation, may be useful in allowing the passage of one or more guidewires or guidewires through them, or may be useful in allowing the administration of fluids such as saline, contrast, drugs, etc. ., distal to the balloon.

The closure device may further comprise a suture to encircle the left atrial appendage after it has been closed with the closure device. Clearly, the closure device may also have the ability to encircle the left atrial appendage without having a suture attached to it. The closure element alone can capture and release the left atrial appendage (ie, it can open and close around the left atrial appendage), which can help facilitate optimal closure of the left atrial appendage, prior to permanent exclusion. In some variations, where a suture is used, the suture may comprise a surgical slip knot. The suture may or may not be attached to the closing element.

The methods described herein may further comprise suture tension. The methods may further comprise releasing tension on the suture, e.g., to help facilitate repositioning of the device, and the like. The methods may further comprise releasing the suture from the closure, tightening the suture and breaking the suture. When the methods include breaking the suture, the suture can be broken in any suitable way. For example, the suture can be broken with a cutting element, or it can be broken by the application of energy (e.g., light energy, thermal energy, RF energy, electrical energy, magnetic energy, electromagnetic energy, kinetic energy). , energy

6/37 chemistry and combinations thereof). When a cutting element is used, it may be an element in the closing device itself, or it may be part of a separate device.

The methods described here may also include confirming satisfactory or optimal closure of the left atrial appendage prior to permanent exclusion, excluding or opening the left atrial appendage with the closing device, repositioning the closing device, re-closing the left atrial appendage, and permanently excluding the left atrial appendage.

Other methods for closing the left atrial appendage are also described. In these methods, a closure device is advanced into the pericardial space adjacent to the left atrial appendage, the left atrial appendage is closed with the closure device, the left atrial appendage is secured with a suture, and then the suture is severed. In such variations, the closure device typically comprises an elongate body having a proximal end and a distal end, and a closure element comprising a complete loop defining a continuous passage therethrough.

In accordance with the methods described above, suture disruption can be performed in any suitable manner. For example, the suture can be broken with a cutting element, or by the application of energy (e.g., light energy, thermal energy, RF energy, electrical energy, magnetic energy, electromagnetic energy, kinetic energy, chemical energy and combinations thereof). When a cutting element is used, it may be an element in the closing device itself, or it may use part of a separate device, or

7/37 some combination of both can be used.

The closure device may comprise one or more expandable elements and the closure device, the suture, or both may comprise a radiopaque material, echogenic material, or some combination thereof. In some variations, the closure device is made from a shape memory material (eg, a nickel-titanium alloy, or the like), and in some variations, the suture is attached to the closure device. In these methods, the closure device may be visualized while advanced, eg using fluoroscope, ultrasound, a combination thereof, etc., and may or may not be advanced over a guide element or guide wire.

Additional methods for closing a left atrial appendage are also described here. These methods typically comprise advancing a first guide having a proximal end and a distal end into the left atrial appendage, through the left atrial appendage, and out of the left atrial appendage such that one of the proximal or distal ends is within the left atrial appendage. vasculature, and one of the proximal or distal ends is within a subthoracic space, and advancing a left atrial appendage closure device into the pericardial space adjacent to the left atrial appendage, and closing the left atrial appendage with the closing device. In such methods, the closure device typically comprises an elongate body having a proximal end and a distal end, and a closure element housed within the elongate body, wherein the closure element comprises a complete loop defining a

8/37 continuous passage through it.

In these methods, the proximal end of the first guide may be within the vasculature, or within the subthoracic space. In some variations, the closure device is advanced into the pericardial space over the first guide. Again, as with all methods described here, any of the devices can be advanced under any variety of visualization techniques. For example, the first guide, closure device, or both can be advanced under fluoroscopic or ultrasound visualization, or both. In some variations, the methods further comprise advancing a second guide into the left atrial appendage, wherein the second guide has a proximal end, a distal end, and comprises an expandable member. The expandable member may be any suitable expandable member (e.g., expandable supports, expandable cage, expandable balloon, or the like). In some variations, the first and second guides are coupled together for at least a portion of the method.

Devices for closing the left atrial appendage are also described here. Some of the devices described herein comprise an elongate body having a proximal end and a distal end, a closure member comprising a complete loop defining a continuous passage therethrough at least partially housed within the elongate body, and a complete suture loop. A full loop of suture may or may not be coupled to the closure element. For example, the device may further comprise a retaining member, wherein the retaining member is configured to retain the closure element and the complete loop.

9/37 suture. The retention member can be configured to perform this task in any suitable way. For example, it may comprise the first and second lumens, wherein the closure element is housed within the first lumen and the complete suture loop is housed within the second lumen. The second lumen may have a weakened region, a perforated region, or a slit or other opening configured to release and/or close the suture upon application of force. In other variations, the retaining member and closure member are withdrawn or otherwise removed, leaving behind and/or closing the complete suture loop. In still other variations, the retention member comprises a first lumen and one or more releasable retention elements, wherein the closure element is housed within the first lumen and the entire suture loop is retained by one or more releasable retention elements. . The retaining member can be any suitable member, for example, a releasable yoke, a polymer stud, and the like.

The closing element may be made of any suitable material. In some variations, the closure element is made from a shape memory material (eg, a nickel-titanium alloy). Similarly, the complete suture loop can be made of any suitable material (eg, any suitable material useful for exclusion or closure). It can be bioabsorbable (eg, biodegradable polymers, etc.), or non-bioabsorbable (eg, non-biodegradable polymers, metals, etc.). The closing element, a complete suture loop, or both may comprise a radiopaque or echogenic material.

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In some variations, the elongated body has one or more curves along its length. The elongate body may or may not be steerable, and may or may not be configured as a catheter. In some variations, the closing element and the complete suture loop are separately operable. In other variations, the device further comprises a cutting element.

Systems for closing a left atrial appendage are also described here. Typically, systems comprise a first guide having a size and length adapted to access the left atrial appendage via the vasculature, wherein the first guide comprises a first alignment member, a second guide having a size and length adapted to access the space pericardium from a subthoracic region, wherein the second guide comprises a second alignment member, and a closure device comprising an elongate body having a proximal end and a distal end, and a closure element housed at least partially therein, wherein the closure element comprises a complete loop defining a continuous passage therethrough. The system may further comprise any suitable or useful device or component.

For example, in some variations, the system even comprises an expandable member. The expandable member can be any suitable expandable member, and in some variations, the expandable member is an expandable balloon with or without one or more passages therein. The expandable member can be configured to be dockable to the first tab.

The systems described here can still

11/37 comprises a suture, which may or may not be coupled to, or coupling with, the closure device. The systems may also comprise a device or element for breaking the suture. In some variations, the closing device is attachable to the second guide.

The first and second alignment members may be any suitable alignment members. For example, they may be or may comprise magnets, radiopaque labels, echogenic labels, members configured to produce one or more audible signals, interconnecting or interlocking members, one or more vacuum members, or the like. In some variations, the alignment members are magnets, which may or may not be located at the distal ends of the first and second guides. The systems may further comprise instructions for using the first guide, second guide, closure device, or any combination thereof. In some variations, the elongate body of the closure device has one or more bends along its length, and the systems further comprise a straightened tube configured to temporarily straighten one or more bends.

Brief Description Of The Drawings

FIG. 1 provides a cross-sectional representation of a heart showing various anatomical structures.

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

FIG. 3A provides a close-up view of

12/37 a distal end of an illustrative device having a retaining member.

FIGS. 3B-3D illustrate illustrative retention members that can be used with the devices described herein.

FIG. 4 provides a close-up view of a distal end of an illustrative device, without a retaining member.

FIG. 5 is an illustration of an illustrative device with the catheter body removed for purposes of description and clarity.

FIG. 6 provides another illustration of an illustrative device with the catheter body removed, here showing more of the device.

FIG. 7 is a close-up view of an illustrative suture retention mechanism, shown here as a suture hook.

FIG. 8 is a close-up view of a distal end of an illustrative device having a lumen therethrough.

FIG. 9 is a top side view of a proximal end variation of the devices described herein.

FIG. 10 is a distorted end view of a proximal end variation of the devices described herein.

FIG. 11 provides a cross-sectional view of a proximal end variation of the devices described herein.

FIG. 12 is an illustrative suture cutter

13/37 that can be used with the systems and methods described herein.

FIGS. 13A and 13B are illustrative guides having alignment members.

FIGS. 14A-14D illustrate an illustrative method of closing the left atrial appendage.

FIGS. 15A-15D illustrate an alternative illustrative method of closing the left atrial appendage.

FIG. 15E illustrates an illustrative device that can be used to carry out the method illustrated in FIGS. 15A15D.

Detailed Description

Devices, systems and methods for closing the left atrial appendage are described here. In this regard, it may be helpful to start by identifying and briefly describing relevant anatomy of the heart. It is shown in FIG. 1 a cross-section view of the heart (100). Shown there are the left atrium (102) and left ventricle (104). Between the left atrium (102) and the left ventricle (104) is the mitral valve (also known as the bicuspid valve), which is defined by a pair of mitral valve leaflets (106). The leaflets are connected to the tendinous cords (108) which are in turn connected to the papillary muscles (110). The papillary muscles attach to the ventricular wall (112). The left atrial appendage (114) is shown adjacent to, and formed from, the wall of the left atrium (102).

As can be seen, the left atrial appendage (114) lies within the confines of the pericardium (116), and is in proximity to the ventricular wall (112). The left atrial appendage typically has a tubular shape that approximates a

14/37 cone, with a slight narrowing or neck at the plane of the orifice where it joins the left atrium (102). In patients with atrial fibrillation, the left atrial appendage (114) is the most common site for thrombosis to form, which over time can dislodge and lead to a devastating stroke. Because effusion is the primary complication of atrial fibrillation, the left atrial appendage is often excluded from the left atrium in those patients undergoing procedures to treat atrial fibrillation, and is often removed or excluded at the time of other surgical procedures, such as, mitral valve surgery to reduce the risk of future stroke. The devices and systems described here help to ensure proper closure of the left atrial appendage, at the neck or base of the left atrial appendage, along the ostial anatomical plane. In this way, the exclusion of the entire left atrial appendage from the systemic circulation can be facilitated.

I. Devices

Devices described herein for closing the left atrial appendage generally comprise a closing element having one or more complete turns. The devices may be suitable for use with minimally invasive access to the left atrial appendage (e.g., through a small sub-xiphoid or other intercostal incision, through a costal cartilage incision, through a canal, through the vasculature , etc.) or may be suitable for use with open surgical procedures. Device lengths can be chosen as desired.

FIGS. 2A and 2B provide different views of an exemplary device that can be used to close the

15/37 left atrial appendage. It is shown in FIG. 2A the device (200) comprising an elongate body (202) having a proximal end and a distal end, and a closure element (204). In this variation, the closure element comprises a complete loop defining a continuous passage therethrough suitable for encircling the left atrial appendage therein. The closing element is at least partially housed within the elongate body (202) and can be advanced therefrom or retracted therefrom. It is also shown in FIG. 2A a lumen (214) for passing tools or fluids therethrough. For example, lumen (214) may allow the passage of a guide (with or without an alignment member), a guide wire, a suture cutter, fluids and/or drugs, and the like. Any number of lumens can be used for any suitable purpose. Suitable lumens will be described again with reference to FIG. 8. It is also shown in FIGS. 2A and 2B a lever (206) having a linear drive slide (208) and handle (210). Additional lever details will be discussed below.

In the variation shown in FIGS. 2A and 2B, the elongate body (202) comprises a curve (212) in its distal portion. In instances where the elongate body (202) of the device comprises one or more bends, a straightened tube, or other straightened mandrel or mechanism may be used to temporarily straighten the elongate body during delivery (e.g., into the pericardial space). is reached). After a specific location has been reached, the straightened tube or mandrel can then be withdrawn. The straightened tube can be made of any suitable material (e.g. rigid plastic, stainless steel,

16/37 combination thereof, etc.). Clearly, it should be understood that the device need not comprise one or more curves as shown in FIGS. 2A and 2B. For example, the elongated body may be straight and flexible, and a pre-bent tube or mandrel may be employed during methods to aid delivery and use (eg, while advancing into the left atrial appendage). Similarly, the elongate body may be straight and flexible, and have a traction wire attached thereto, so that when the traction wire is removed proximally, the elongate body flexes and bends. In this variation, the elongated body can be maneuvered as appropriate. It should be understood that any of the devices described herein may be configured for drivability, or may be configured for robotic use (eg, configured for use with one or more robotic devices or other automated type device).

FIG. 3A provides the additional details of a suitable closing element. A distal portion (300) of a suitable closure device having an elongate body (302) and closure member assembly (304) is shown. In FIG. 3A, details of an elongated body extension, or tip (306) can be seen. This tip may be heat formed or injection molded, or may be integral with the remainder of the elongate body (302). In instances where a full loop of suture (308) is used, the tip (306) may act to house a suture knot therein. It should be understood that when reference is made to the elongate body, it means including any such point (306) as shown in FIG. 3A. Also apparent in FIG. 3A is the complete loop of suture (308), which is shown passing through the tip (306) in a proximal direction and in a

17/37 retaining member (312) in a distal direction. Also shown is the passage through the tip (306) in a proximal direction and to the retention member (312) in a distal direction is the closing element (310), which will form a complete loop to encircle the left atrial appendage. As can be seen in FIG. 3A, the retaining member is configured to retain the closure element and the complete suture loop.

FIGS. 3B-3D illustrate illustrative retention members that can be used with the devices described herein. FIG. 3B shows an end view of a retaining member (314) having first and second lumens (316, 318) for retaining a closure element and a complete suture loop therein. In this variation, the second lumen (318) has a slit or other opening (320) along its length to allow the suture to pass through it when ready to be prepared. Clearly, it is to be understood that the first and second lumens may be positioned or oriented in any suitable manner with respect to each other, and similarly, the slit or other opening in the second lumen may be positioned or oriented in any suitable manner with respect to the first lumen (e.g., may be approximately 180°, approximately 150°, approximately 120°, approximately 90°, approximately 60°, approximately 30°, or the like, from the first lumen (316)). FIG. 3C provides an illustration of a retaining member having a first lumen (322), a second lumen (324), and a slot (326). In this variation, the slit (326) is positioned closer to the first lumen (322) than the slit of FIG. 3B. Slit opening width or spacing can be selected

18/37 as desired or appropriate. Similarly, the slit need not extend or be continuous along the entire length of the retaining member. In some variations, the slits may have forks or arms along their length to aid in the capture and retention of the suture in them. In other variations, the slits may be covered at spaced locations along the slits with a biodegradable polymer, temporarily used to baste or maintain the suture. Clearly, in still other variations, the retention member does not comprise a slot and instead comprises some other type of retention mechanism, such as the forks or studs described above. In still other variations, there are no slits or openings in the retention member and the complete suture loop is released upon removal or withdrawal of the retention member and closure of the device.

FIG. 3D provides another variation of a retaining member. In this variation, the retaining member has a first lumen (328), second lumen (330), and a separation region (332). The separation region can be constructed in any suitable way. For example, the parting region may comprise a perforated region adapted to perforate and release the suture with the application of force. Alternatively, the region of separation may have a thin wall or other type of weakened region that can be configured to break and release the suture. It is to be understood that the retaining member may have any suitable geometry or shape, and may be made of any suitable material. Similarly, lumens do not need to be full circles or have a circular cross-section geometry. When these or other types of members of

If retention devices are used, the full loop of suture may be torn, withdrawn or otherwise released from the retention member after it has been properly positioned and tightened, as desired.

The components described above may be made of any suitable material. For example, the closure element may be made from a shape memory material, such as a shape memory alloy (e.g. nickel-titanium alloy, etc.), it may be made from steel stainless, polyester, nylon, polyethylene, polypropylene, some combination thereof, etc. Similarly, the complete suture loop may be made of any suitable material useful in exclusion or closure, and the term suture complete loop should be understood accordingly. For example, it may be made from a biodegradable material (e.g. polyactic acid, polyglycolic acid, polyactic-co-glycolic acid, etc.), or it may be made from a non-biodegradable material (e.g. metal, steel, polyester, nylon, propylene, silk, and combinations thereof). In some variations, as will be described in more detail below with reference to the methods, the suture loop is made of a biodegradable material so that the suture loop degrades after a period of time has elapsed (e.g. ., so that sufficient healing is achieved). It should be understood that any part of the device may comprise, include, or be made of a radiopaque or echogenic material to help facilitate visualization. For example, the closure element, the complete suture loop, the elongate body, or any combination of these components may comprise a radiopaque or echogenic material.

The complete suture loop and the

20/37 enclosure can be configured to have any appropriate perimeter. For example, they might have a perimeter of about 4.5 inches in a fully expanded state, a perimeter of about 4.3 inches, about 3.3 inches, about 4.0 inches, about 3.5 inches, about 3.3 inches, 3.0 inches, about 2.7 inches, about 2.5 inches, about 1.5 inches, about 1.25 inches, or the like. Clearly, these perimeters will vary as the closure element and the complete suture loop are engaged and retracted.

For additional clarity, FIG. 4 provides a view of the distal portion (300) of FIG. 3A , without the retaining member (312), thus showing the one-turn nature of the closure element (310) and suture (308). FIG. 5 is a view of the distal portion (300), without the retaining member (312), tip (306) and elongate body (302), thus providing additional details of this variation of the device. The closure element (310) and the suture (308) are clearly shown. The suture (308) further comprises a surgical knot (e.g., a slipknot on one side or other suitable knot) (500). Also shown is the anchoring feature (502), here shown as a tube, for anchoring one side of the closing element (310). The opposite side of the closing element is the active or driving side (ie one side remains anchored while the other side has the additional active length). Clearly, when anchoring is used, it can be done in any suitable way. In other variations (not shown here), both sides of the closing element are active and actionable (ie, neither side is anchored). The device can also understand

21/37 a suture tube (504) to facilitate passage of the suture.

FIG. 6 shows additional proximal detail of a suitable closure device. In this view, the elongated body and tip have been removed, but the retaining member remains. Of specific interest here is the suture hook (600). The suture hook (600) captures the full loop of suture (308), so that the closing element (310) can be advanced and retracted separately from the full loop of suture (308) when the two are coupled together. That is, the suture hook (600) prevents the suture from tightening as the closure element is operated, so that the device can be positioned as desired before the suture is triggered. The suture hook (600) can also help to prevent excess suture from opening and closing, and thus helping to prevent excess suture from becoming trapped in anatomical structures, instruments, etc. It is also shown in FIG. 6 a proximal length of the closure element (602). In some variations, it may be useful to have at least a portion of the proximal length of the closure member (602) coated with a lubricating coating, in order to help facilitate sliding actuation. Any suitable lubricating coating can be used (eg PTFE, etc.). The suture hook (600) is shown in greater detail in FIG. 7. While the suture hook shown in FIG. 7 has a rounded atraumatic tip, it doesn't have to be that way. In fact, any suitable tip can be used. The suture hook can be made of any suitable material.

FIG. 8 provides details of the distal portion of an illustrative closure device (800), here

22/37 comprising at least one lumen (802) in the elongate body (804). Lumen can be used for any suitable purpose. For example, it may be used to allow one or more guides or guide wires to pass therethrough, one or more tools therethrough, or the like. The lumen can also be used as a flow lumen, a vacuum lumen, a drug delivery lumen, or the like. The elongated body can comprise any number of lumens, and it should be understood that the lumens need not traverse the entire length of the elongate body, nor form a fully coalesced passageway (i.e., the use of lumens here is intended to capture instances where a slot or groove can be used with one or more guides, guide wires, or additional tools).

FIG. 9 is a variation of a suitable lever (900) for the devices described herein. In this variation, the lever comprises a linear drive slide (902) for driving the closing element, and a suture puller (904) for driving the suture. While not shown, the suture hook, described above, or such similar feature, helps to enable the separate actuation capability described herein. Thus, when the slide (902) is pushed distally, the closure element which has been at least partially retained within the elongate body will be advanced distally, and the size of the complete turn of the closure element will become larger. Conversely, when the slide is retracted proximally, the closing element will retract and the size of the full turn will be smaller. The complete suture loop is not affected in this process. Instead, the complete suture loop

23/37 in this variation is controlled by the suture puller. Clearly, the complete suture loop does not need to be pulled by a puller. That is, the suture can be separately driven by an additional slide, loop, button, or the like. Similarly, the closing element does not need to be operated by a slide. It can be activated by a button, handle, handle, or similar.

Also shown in FIG. 9 the suture cutting groove (906). While not easily shown in this view, the suture runs through the lever and into the handle. The suture cutting groove allows the suture to be cut easily as the suture passes through the groove and the groove provides a viewing window and access point for suture tearing. Clearly, the suture does not need to be torn in such a way. In some variations, the closure device itself comprises a cutting element for breaking the suture (eg, a blade actuated by a button or some other mechanism). FIG. 10 provides a distorted end view of the lever shown in FIG. 9, so that additional details can be seen. Specifically, shown here is the suture puller lock (1000) and luer connection (1002) at the proximal end of the lumen lever.

FIG. 11 provides a cross-sectional view of a portion of the lever (1100), here showing a length of the lever including the suture puller (1102) and the slide driver (1104) in their most retracted position. The suture puller (1102) comprises an outer puller (1106), and the outer puller bearing (1108), inner bearing (1110) and inner puller bearing (1112), thrust bearing (1114) and

24/37 slide clutch plates (1116) which when actuated (when the handle (1102) is rotated or rotated) apply tension over the complete suture loop causing it to release from the retaining member. In one variation, the slide clutch plates (1116) have specific force settings and are configured to provide tactile feedback to the operator indicating closure. In other variations, the clutch plates (1116) may have a specific force limitation for the purpose of protecting against shearing or shearing of tissue by the suture during release or tightening of the complete suture loop. For example, in these variations, once the complete suture loop has reached a predetermined force, the outer puller (1106) and outer puller bearing (1108) can disengage from the inner handle (1110) and inner puller bearing (1112) when sliding or similar (eg similar to gas cap when over-tightened).

Also shown is a suture coil area (1118) and a suture break groove (1120), which, as briefly described above, are used to assist in finishing the suture by placing a blade, scalpel, or other sharp instrument in the same. As described above, in some variations, the closure device itself comprises a suture cutting mechanism or device, and this may be located in the same location as the suture break groove (1120) or some other location. For example, the device may include a blade or other cutting mechanism that may be actuated by a blade, handle, puller, etc., located or not located at the location of the suture break groove. The lumen (1122) can be used for placement of a guide (with or

25/37 without an alignment member), guide wire, one or more tools (eg, a suture cutter, viewing devices, etc.), one or more fluids (eg, saline, drugs , etc.), as described above.

II. methods

Methods for closing the left atrial appendage are also described here. The left atrial appendage can be accessed in any suitable way, and any of the devices described here can be used. For example, the left atrial appendage can be accessed from the inside of the heart, or it can be accessed from the outside of the heart. In some variations, the left atrial appendage is accessed from inside the heart and outside the heart. Typically, the appendix is ​​closed from outside the heart, even when accessed from inside the heart.

In variations where the left atrial appendage is accessed from inside and outside the heart, it may be helpful to employ the use of guides having alignment limbs. In this way, access to the left atrial appendage can be more easily facilitated. It may also be helpful to employ the use of a positioner or stabilizer to help position devices relating to the left atrial appendage and stabilize the appendix while it is being closed. The positioner or stabilizer may be any suitable stabilizer or positioner, e.g., an expandable member or the like. More details on this will be described below.

In some variations, methods of closing the left atrial appendage comprise advancing a closing device into the pericardial space and adjacent to the left atrial appendage.

26/37 left atrial appendage, closing the left atrial appendage with the closing device, securing the closed left atrial appendage with a suture, and then, breaking the suture. The closure device may be any suitable closure device, such as a device having an elongate body with a closure element comprising a complete loop defining a continuous passage therethrough, as described above. The suture may be torn in any suitable manner, and at any suitable location along its length (i.e., from immediately adjacent to the node in the left atrial appendage to nearly proximal to, or nearly distal to, the skin surface) . In some instances, it may be desirable to break the suture at the knot itself (eg, in instances where it is desirable to release tension on the suture fully).

An illustrative device (1200) for breaking a suture is shown in FIG. 12. The device illustrated may be threaded onto the suture, and then actuated to cut the suture with a blade or similar cutting feature housed within the distal portion (1202). While a device having a lodged blade is illustrated in FIG. 12, any suitable cutting device may be used, and the device may be made of or comprise any suitable materials (eg, a radiopaque or echogenic material). In some variations, the closure device has a cutting element therein for cutting the suture. Clearly, the suture does not need to be broken with a blade or other cutting feature. The suture can be broken by the application of energy. For example, the suture can be broken by applying light energy, thermal energy, RF energy, electrical energy, magnetic energy, electromagnetic energy,

27/37 kinetic energy, chemical energy, and combinations of any of the above. Additional methods will now be described.

A. Transseptal and Pericardial Access

In some variations, methods to close the left atrial appendage include accessing the left atrial appendage from inside the heart and from outside the heart. In these variations, one or more guides having alignment members are often used to align internal and external access devices together. To access the inner part of the heart, the vasculature is typically used. For example, access can be gained via one or several of several veins or arteries (jugular, femoral, carotid, etc.). In some variations, the heart is accessed internally via the common femoral vein (eg, the left common femoral vein) using a standard Seldinger technique with a needle. An introducer wire can then be advanced through the needle, followed by an introducer sheath. The introducer wire can then be removed. In some variations, a guiding catheter sheath may be placed as an alternative to an introducer sheath, or the initial sheath may be replaced with a guiding catheter sheath.

Using the fluoroscope, an angiogram performed through the sheath, a catheter placed through the sheath, a guiding catheter sheath, or any combination thereof, can be performed to observe the anatomical features and access route considerations for the purpose of transseptal access in the left atrium (eg, tortuosity, clots, devices such as vena cava filters, etc.). Fluoroscope, ultrasound, intracardiac echocardiography, extracardiac echocardiography, transesophageal echocardiography, or combinations of the

28/37 can be used to help visualize the transseptal access to the left atrium, and access to the left atrium can be obtained using standard transseptal access techniques.

For access to the heart from the outside, a sub-thoracic access point can be used. The access point is typically identified based on the patient's anatomical features. In some variations, the access point is right of the xiphoid process and directed at the patient's left shoulder, but it can be in any suitable location (eg, intercostal access via a sternotomy, thoracostomy, or thoracotomy, or in the costal cartilage itself) . Once the access point has been determined, a needle (eg, a 17G Tuohy needle) can be advanced using standard pericardiocentesis techniques under fluoroscopic guidance. After access to the pericardium has been obtained, a guidewire can be advanced through the needle under fluoroscopic visualization into the pericardial sac. The needle can then be removed. Access to the pericardial space was then obtained.

With reference to the figures, after access to the inside and outside of the heart has been obtained using the devices and techniques described above, the devices of the current invention are ready for use. For example, the first (1300) and second (1302) guides have alignment members as shown in FIGS. 13A and 13B, respectively, and can be used to guide the procedure. The alignment member can be any suitable alignment member (eg, interconnecting elements, one or more vacuum members, radiopaque or echogenic markers, members that are configured to produce an audible response, magnets, etc.). Here, members of

29/37 alignment are magnets (1304, 1306) located at the distal ends of the guides. The magnets may be made of or comprise any suitable magnetic material, e.g., a rare earth magnet, such as neodymium-iron-barium, cobalt-samarium, or other strong fixed magnetic elements. These guides can be used to guide additional tools and/or devices to the left atrial appendage.

The guides can be of any suitable lengths and/or dimensions. For example, the guides may have a diameter of about 0.010 to about 0.050, about 0.020 to about 0.030, or the like. In some variations, the first guide has a diameter of about 0.025 and the second guide has a diameter of about 0.035. 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 variations, the first guide is about 250 cm long and the second guide is about 90 cm long. The outside diameter of the alignment element can also be selected as desired. For example, it can be from about 0.05 to about 0.2 or more. In some variations, the outside diameter of the first guide alignment member is about 0.106 and the outside diameter of the second guide alignment member is about 0.170. It should be understood that these dimensions are suitable for any guide, not just guides having alignment members comprising one or more magnets.

For example, with reference to FIG. 14A, the

The first guide (1400) can be advanced in the left atrial appendage (1404), while the second guide (1402) can be advanced in the pericardial space adjacent to the left atrial appendage. Any of these tabs can be advanced under any variety of visualization techniques, eg, fluoroscopic visualization, ultrasound visualization, some combination thereof, and so on. A balloon catheter (1406) or other expandable member may be advanced over the first guide, or in conjunction with the first guide (e.g., may be attached to or part of the first guide) and into the left atrial appendage as shown in FIG. . 14B. Similarly, a closure device (1408) may be advanced over the second guide, or in conjunction with the second guide (e.g., may be coupled with or part of the second guide), as shown in FIG. 14B.

In instances where a balloon is used as an expandable member, it can be made of any suitable material. For example, it may be made of polysopropene, or other suitable materials. Similarly, the balloon can be of any suitable dimensions. For example, it may have an outside 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 be from about 5mm to about 50mm in length, from about 10mm to about 20mm in length, or the like. In some variations, the balloon has an outside diameter of approximately 20-30 mm, and a length of approximately 20 mm.

The expandable limb (in this variation, shown as an expandable balloon) is inflated to position and stabilize the left atrial appendage, as shown in FIG.

31/37

14C. In its expanded state, the expandable limb helps to locate the ostial plane of the left atrial appendage. Specifically, when the expandable limb is expanded, the left atrial appendage is distended and its shape is changed from gross conical to gross spherical, thus better defining the junction between the left atrial appendage and the left atrium. In addition, the expandable limb in its expanded state may be at a much higher pressure than the proper left atrium, resulting in a significant differential in tension between the left atrial appendage and the left atrium. The expandable member may have one or more passages therethrough for the contrast passage to facilitate visualization.

While the expandable member is still in its expanded state, a closure element (1410) of a closure device (1408) can be placed around the left atrial appendage and closed as shown in FIG. 14D. However, in some variations, the closure element is placed around the left atrial appendage while the balloon is in its deflated or unexpanded state, and then the balloon is expanded. A suture can then be prepared from the device, tightened around the closed appendix, released from the device, and severed, leaving the closed appendix in place. Clearly, in some instances, it may be desirable to confirm proper closure of the appendix before tightening the suture, and then again after the suture has been tightened using fluoroscopic or other visualization techniques. If closing is not suitable or otherwise undesirable, the full turn can be opened, repositioned, closed and then confirmed again.

32/37

Specifically, it is desirable that the left atrial appendage be closed as close to the ostial anatomical plane as possible (ie, the opening that separates the left atrium from the left atrial appendage). If the left atrial appendage is closed above the orifice plane (toward the tip of the left atrial appendage or away from the anatomic ostial plane), this can result in a persistent left atrial appendage diverticulum, which in turn can result in a additional site or focus for thrombus formation despite complete exclusion of the left atrial appendage from the left atrium. In some individuals, the geometry of the left atrium and left atrial appendage may be such that the neck or narrowing between them is insufficiently defined from the epicardial, or external, aspect. Furthermore, the external geometry of the left atrial appendage junction is difficult to differentiate from an epicardial perspective. This may be compounded by the fact that the anatomy is moving vigorously when procedures are performed while the heart is beating and the lungs remain inflated (ie, closed-chest procedures). From an internal aspect, or endocardial view, fluoroscope and ultrasound methods provide limited information or ability to mark true three-dimensional features of the ostial anatomical plane. Thus, the use of the devices described here helps to facilitate proper positioning and closure of the left atrium, and can be used during beating heart procedures, thus resulting in significant advantages over known devices for closing the left atrial appendage.

Clearly, many variations on this method

33/37 are possible. For example, the guides can be used as guide wires or rails for additional devices to slide on, or the guides can be attached to the devices described above. Additional guide wires or guide wires can also be used, and confirmation steps can be used at all times as appropriate. Guides having alignment members thereon may be used or removed during methods as appropriate or desirable. In some variations, the closure device has one or more bends or bends along its length, and a straightener tip or straightened tube is used to temporarily straighten the bend during advancement of the device into the pericardial space. In other variations, where the device includes a straight elongated body, a pre-curved device may be used to aid administration after adequate access has been obtained. In some variations, the complete suture loop is made from a biodegradable material and is configured to biodegrade after sufficient time has passed to ensure healing or formation of new tissue that effectively seals the appendix.

B. Transseptal or Pericardial Access

In the methods described above, access to the left atrial appendage was obtained from inside and outside the heart. Clearly, the left atrial appendage can be closed using the systems and devices described here without performing both access procedures as described above. For example, in some variations, the methods comprise advancing a first guide having a proximal end and a distal end in the left atrial appendage, through the atrial appendage.

34/37 and out of the left atrial appendage such that one of the proximal or distal ends is within the vasculature, and one of the proximal or distal ends is within the subthoracic space.

Once access has been gained in this way, a closure device can then be advanced into the pericardial space adjacent to the left atrial appendage, and the left atrial appendage closed. Clearly, the proximal end of the first guide may be within the vasculature, or it may be within the subthoracic space. In some variations, the closing element is advanced into the pericardial space over the first guide. In other variations, these methods further comprise advancing a second guide into the left atrial appendage, where the second guide comprises an expandable limb. The second lead can be advanced to the left atrial appendage over the first lead, although it does not need to be advanced in such a way.

Other methods for closing the left atrial appendage without performing both access procedures (ie, transseptal and epicardial) are also described here. Generally speaking, these methods comprise accessing the inside of the left atrial appendage from the epicardial space, using a device that is configured to pierce the appendix wall. An expandable limb, such as a balloon, is then advanced through the perforation and into the left atrial appendage and inflated to help position the left atrial appendage while it is being closed.

Referring now to the figures, FIG. 15A shows a left atrial appendage closure device (1500) being advanced adjacent to the left atrial appendage

35/37 (1 502) from outside the heart. The closing device can be advanced in any suitable way. For example, it can be advanced via a sub-thoracic approach, or via an intercostal or infracostal approach, via an open surgical approach, or similar, as described above. The closure device comprises a closure element (1504) (e.g., a full turn as shown in FIG. 15A) which is advanced over the left atrial appendage (1502) and squeezed to close the appendix. The device may comprise a blade or other cutting mechanism (1506), and such mechanism may be used to puncture the left atrial appendage after it has been closed, so that access can be gained to the inside of the appendix as shown in FIG. 15B. Once access to the inside of the appendix has been gained, an expandable limb (which may be part of the closure device or be a different device intended to cooperate with the closure device) can be expanded within the left atrial appendage to position accordingly. described above. The left atrial appendage can then be closed again (and confirmed with the visualization techniques described above), and a suture prepared and permanently fixed to the left atrial appendage in its closed position. The device (1500) can then be removed proximally, and the suture (1510) severed using any of the techniques described above. An illustrative device (1512) for performing this method is shown in FIG. 15E. A device is shown having a proximal end (1513) and a distal end (1515), balloon (1514), retractable blade (1520), blade driver (1516) and inflation lumen (1518) for inflating the balloon. Clearly, other suitable devices can also

36/37 be used to perform this method.

III. systems

Also described herein are systems for closing a left atrial appendage. Generally, the systems may comprise a closure device useful for performing a left atrial appendage closure procedure as described above, along with one or more additional components. For example, the system may comprise a first guide having a size and length adapted to access the left atrial appendage through the vasculature and comprising an alignment member, a second guide having a size and length adapted to access the pericardial space from a subthoracic region and comprising an alignment member, and a closure device. The alignment member can be any suitable alignment member. For example, the alignment member may comprise radiopaque or echogenic markers, members configured to produce an audible response, one or more interconnect members, one or more vacuum members, or magnets. In some variations, the first and second guide alignment members comprise the magnets as shown in FIGS. 13A and 13B, respectively.

The closing device may be any of the above-described closing devices. For example, the closure device may be one having a closure element comprising a complete turn defining a continuous passage therethrough. The system may further comprise an expandable member or a device comprising an expandable member. the expandable member

37/37 may be any suitable expandable member, such as, e.g., the balloon catheters described above. The expandable member may have one or more passages therein to allow contrast or other fluids to pass therethrough. The system may further comprise a full loop of suture, and the full loop of suture may not be coupled or attachable to the closure device.

The systems may also comprise one or more suture breaking devices. Similarly, the systems may also comprise one or more devices for temporarily straightening one or more bends along the elongate body of the closure device. Clearly, the device may comprise instructions for using all, any, or a portion of the system components (e.g., first guide, second guide, closure device, straightened tube, suture cutter, or some combination thereof).

While the foregoing invention has, for the purposes of clarity and understanding, been described in some detail by way of illustration and example, it will be apparent that certain changes and modifications may be practised, and are intended to be within the scope of the appended claims.