Left atrial appendage occlusion device

Abstract

An occlusive device for the left atrial appendage is plastically deformable and biodegradable.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of the filing date of U.S. Provisional Application No. 62 / 852,952, filed on May 24, 2019, the content of which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0003] The present invention relates to devices, systems, and methods for occluding the left atrial appendage of the heart. BACKGROUND ART

[0004] The human heart is a four-chambered muscular organ that provides blood circulation through the body during the cardiac cycle. Referring Figure 1 , the four main chambers include the right atrium RA and right ventricle RV that provide pulmonary circulation, and the left atrium LA and left ventricle LV that supply oxygenated blood received from the lungs to the rest of the body. The heart also includes the left atrial appendage LAA, which is a small ear-shaped sac in the muscular wall of the left atrium LA. In a normal heart, when the heart contracts, the blood in the left atrium LA and the left atrial appendage LAA is squeezed out of the left atrium LA and into the left ventricle LV.

[0005] When a patient has atrial fibrillation, the electrical impulses that control the heartbeat do not travel through the heart in an orderly manner. Instead, many impulses start simultaneously and spread through the atria. The rapid and chaotic impulses do not allow the atria to have time to contract and / or effectively squeeze blood into the ventricles. Because the left atrial appendage LAA is a small sac or pouch, blood accumulates there and can form clots in the left atrial appendage LAA and the atria. When the blood clot is pumped out of the heart, the blood clot may cause a stroke. The likelihood of a person with atrial fibrillation having a stroke is 5 to 7 times that of the general population. Additionally, studies have shown that in patients without heart valve disease, most of the blood clots that occur in the left atrium LA originate in the left atrial appendage LAA.

[0006] Treatments for reducing the stroke risk in patients with atrial fibrillation include taking blood thinners such as warfarin. However, in some cases, the blood thinners are not tolerated by the patient or may increase other risks. Therefore, in some cases, it may be necessary to block or occlude the LAA so that clots do not form in the LAA and, if a clot forms in the LAA, the clot cannot escape from the LAA.

[0007] Therefore, there is a need for a catheter-based occlusion system for occluding or blocking the LAA. SUMMARY OF THE INVENTION

[0008] Embodiments of the present disclosure relate to an occluding device for occluding the left atrial appendage. In an embodiment, the occluding device includes a first portion and a second portion, and the second portion is attached to the first portion. The occluding device is plastically deformable from a radially compressed configuration to a radially expanded configuration. In the radially expanded configuration, the first portion has a larger cross-sectional profile than the second portion. In some embodiments, the occluding device is biodegradable.

[0009] Embodiments of the present disclosure also relate to an occluding device for occluding the left atrial appendage, the occluding device including a braided mesh that is plastically deformable from a radially compressed configuration to a radially expanded configuration, wherein the braided mesh is biodegradable. In an embodiment, the occluding device further includes a first collar and a second collar, wherein a first longitudinal end of the braided mesh is coupled to the first collar, and a second longitudinal end of the braided mesh is coupled to the second collar.

[0010] Embodiments of the present disclosure also relate to an occluding device for the left atrial appendage, the occluding device including a first collar, a second collar, and a plurality of struts extending between the first collar and the second collar, each strut of the plurality of struts having a first end coupled to the first collar, a second end coupled to the second collar, and an intermediate portion extending between the first end and the second end. In a radially compressed configuration, the first collar and the second collar are disposed a first distance apart, and the plurality of struts are circumferentially disposed about a central longitudinal axis. In a radially expanded configuration, the first collar and the second collar are disposed a second distance apart, the second distance being less than the first distance. In the radially expanded configuration, the intermediate portion of each strut of the plurality of struts bends radially outward. In some embodiments, the intermediate portion of each strut of the plurality of struts includes a hinge for preferentially bending to the radially expanded configuration. In some embodiments, the occluding device is biodegradable. In some embodiments, the plurality of struts are plastically deformable from the radially compressed configuration to the radially expanded configuration.

[0011] Embodiments of the present disclosure also relate to an occluding device for the left atrial appendage, the occluding device including a biodegradable shape memory wire, the wire including: a straightened configuration in which the wire is substantially straight; and a deployed configuration in which the wire is configured to occlude the left atrial appendage. In some embodiments, the shape of the wire is set to the deployed configuration. In some embodiments, the wire in the deployed configuration is in a helical shape. In some embodiments, the wire in the deployed configuration is in a coil shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The foregoing and other features and advantages of the present invention will become apparent from the following description of embodiments herein shown in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of this specification, further serve to explain the principles of the present invention and enable a person skilled in the art to make and use the present invention. The drawings are not drawn to scale.

[0013] Figure 1 is a schematic cross-sectional view of a mammalian heart.

[0014] Figure 2 is a schematic side view of an occlusion device according to an embodiment herein.

[0015] Figure 3 is a schematic cross-sectional view of an occlusion device according to another embodiment herein.

[0016] Figure 4 is a schematic cross-sectional view of the distal end of a balloon catheter of an occlusion device on which Figure 3 is mounted, wherein the balloon of the balloon catheter is not inflated and the occlusion device is in a radially compressed configuration.

[0017] Figure 5 is a side view of the distal end of a balloon catheter of an occlusion device on which Figure 3 is mounted, Figure 4 wherein the balloon is inflated to radially expand the occlusion device to a radially expanded configuration.

[0018] Figure 6 is a schematic view of an occlusion device deployed within the left atrial appendage Figure 3

[0019] Figure 7 is a schematic view of an occlusion device according to another embodiment herein mounted on a catheter according to another embodiment herein, wherein the occlusion device is in a radially compressed configuration.

[0020] Figure 8 is Figure 7 a schematic view of a catheter and an occlusion device, wherein the occlusion device is in a radially expanded configuration.

[0021] Figure 9 is Figure 7 a schematic view of a catheter and an occlusion device, wherein the occlusion device is in a radially expanded configuration and the outer shaft is retracted.

[0022] Figure 10 is Figure 7 a schematic view of a catheter and an occlusion device, wherein the occlusion device is in a radially expanded configuration and the proximal portion of the inner shaft is disconnected from the distal portion of the inner shaft.

[0023] Figure 11 is a schematic view of an occlusion device deployed within the left atrial appendage​Figure 7 Schematic diagram of an occlusion device.

[0024] Figure 12 is Figure 7 Schematic diagram of an embodiment of the inner shaft of a catheter of

[0025] Figure 13 Schematic diagram of an occlusion device according to another embodiment herein mounted on a catheter according to another embodiment herein, wherein the occlusion device is in a radially compressed configuration.

[0026] Figure 14 is Figure 13 Schematic diagram of a catheter and an occlusion device of , wherein the occlusion device is in a radially expanded configuration.

[0027] Figure 15 is Figure 13 Schematic cross - sectional view of a catheter and an occlusion device of , which shows an embodiment of the shaft of the catheter, wherein the occlusion device is in a radially compressed configuration.

[0028] Figure 16 is Figure 15 Schematic cross - sectional view of a catheter and an occlusion device of , wherein the shaft moves to radially expand the occlusion device.

[0029] Figure 17 is Figure 13 Schematic diagram of an embodiment of a collar of an occlusion device of .

[0030] Figure 18 is Figure 17 Schematic diagram of a collar of , wherein the flaps of the collar cover the opening of the collar.

[0031] Figure 19 is deployed within the left atrial appendage Figure 13 Schematic diagram of an occlusion device of .

[0032] Figure 20 Schematic diagram of an occlusion device according to another embodiment herein, the occlusion device being disposed within the catheter in a straightened configuration.

[0033] Figure 21 is an occlusion device of released from the catheter portion and in a partially deployed configuration Figure 21 Schematic diagram of an occlusion device of .

[0034] Figure 22 is deployed within the left atrial appendage Figure 20 Schematic diagram of an occlusion device of .

[0035] Figure 23 is a schematic plan view of an occlusion device of deployed within the left atrial appendage as viewed from the perspective of the left atrium Figure 20 of .

[0036] Figure 24 is deployed within the left atrial appendage Figure 20 of an occluding device, wherein the occluding device has different preset shapes.

[0037] Figure 25 is a schematic view of an occluding device in a radially compressed configuration according to another embodiment herein.

[0038] Figure 26 is in a radially expanded configuration Figure 25 of an occluding device.

[0039] Figure 27 is a schematic view of an occluding device in a radially compressed configuration according to another embodiment herein.

[0040] Figure 28 is in a radially expanded configuration Figure 27 of an occluding device. DETAILED DESCRIPTION

[0041] Reference will now be made to the drawings to describe specific embodiments of the present invention, wherein like reference numerals indicate identical or functionally similar elements. The terms "distal" and "proximal" are used in the following description to refer to the position or orientation of a catheter and / or other system components herein with respect to a treating clinician. Thus, "distal" and "distally" refer to a position that is away from the treating clinician or in a direction away from the treating clinician, and "proximal" and "proximally" refer to a position that is closer to the treating clinician or in a direction toward the treating clinician. The terms "distal" and "proximal" are used in the following description to refer to a native blood vessel, a native valve, or a device to be implanted in a native blood vessel or native valve, and refer to the direction of blood flow. Thus, "distal" and "distally" refer to a position in the downstream direction with respect to the direction of blood flow, and the terms "proximal" and "proximally" refer to a position in the upstream direction with respect to the direction of blood flow.

[0042] The following detailed description is merely exemplary in nature and is not intended to limit the present invention or the application and uses of the present invention. It is not intended to be bound by any theory, whether expressed or implied, presented in the foregoing technical field, background art, summary, or the following detailed description.

[0043] Figure 1 is a schematic cross-sectional view of a human heart HE depicting four heart chambers (right atrium RA, right ventricle RV, left atrium LA, left ventricle LV) and the left atrial appendage LAA. As described above, patients with non-valvular atrial fibrillation are at risk of forming blood clots in the left atrial appendage LAA and releasing the blood clots therefrom, which may cause a stroke.

[0044] Figure 2 and3 A similar embodiment of the occluding devices 100, 100' in a radially expanded configuration for occluding the left atrial appendage is shown. Figure 4 And 5 A balloon catheter having mounted thereon Figure 3 the occluding device 100' is shown, but the balloon catheter can also be used for Figure 2 the occluding device 100. Figure 6 The occluding device 100' disposed in the left atrial appendage LAA is shown. Figure 3 the occluding device 100'.

[0045] Returning to reference Figure 2 , the occluding device 100 includes a first portion 110, a second portion 120, and a third portion 130. In Figure 2 an embodiment, the second portion 120 is disposed between the first portion 110 and the third portion 130 and connects the first portion 110 to the third portion 130. Additionally, when the occluding device 100 is in the radially expanded configuration, the diameter or cross-sectional profile of the second portion 120 decreases. Thus, in the radially expanded configuration, the first portion 110 has a first cross-sectional profile or diameter D1, the second portion 120 has a second cross-sectional profile or diameter D2, and the first third portion 130 has a third cross-sectional profile or diameter D3. The second diameter D2 is less than the first diameter D1 and the third diameter D3. In some embodiments, the third diameter D3 may be equal to the first diameter D1. In other embodiments, the third diameter D3 may be greater than or less than the first diameter D1.

[0046] In Figure 2 an embodiment, each portion 110, 120, 130 is formed by a series of elements or rings 112 disposed adjacent to each other about a central longitudinal axis LA. Each ring 112 includes struts 114 and bends 116, wherein adjacent struts 112 are connected to each other by corresponding bends 116. In some embodiments, adjacent rings 112 are connected to each other by connectors 118. Specific details regarding the components of the occluding device 100 may vary. For example, but not by way of limitation, instead of connected rings 112, the occluding device 100 may be formed by a waveform including struts and bends, and then the waveform may be helically wound to form the occluding device 100. In some embodiments, a single waveform may form all of the first portion 110, the second portion 120, and the third portion 130. In other embodiments, individual waveforms may be used for each of the first portion 110, the second portion 120, and the third portion 130, and the individual waveforms may be connected to form the occluding device 100. In other embodiments, the occluding device 100 may be formed by braided metal wires.

[0047] Figure 3An occluding device 100' is shown that is similar to the occluding device 100, except that the occluding device 100' only includes a first portion 110 and a second portion 120, wherein in the radially expanded configuration, the second portion 120 has a reduced second cross-sectional profile D2 compared to the first cross-sectional profile or diameter D1 of the first section 110. The first section 110 and the second section 120 of the occluding device 100' can be manufactured in the same manner as described above for the occluding device 100, including the described alternatives.

[0048] In each of the occluding devices 100, 100', it is desirable to make the second diameter D2 as small as possible. As described in more detail below, when using a balloon catheter to deliver and deploy the occluding device 100 or the occluding device 100', the second diameter D2 only needs to be large enough so that the balloon catheter can be withdrawn from the radially expanded occluding device 100 or 100' after the balloon of the balloon catheter has been deflated.

[0049] The occluding devices 100, 100' can be formed from a plastically deformable material such that the occluding devices 100, 100’ are plastically deformable. Such devices can also be referred to as balloon or mechanically expandable. Additionally, the occluding devices 100, 100' can be biodegradable or bioerodible such that the occluding device degrades / erodes over time after being deployed within the left atrial appendage LAA of the human heart HE. For example, but not by way of limitation, suitable plastically deformable and biodegradable / bioerodible materials for the occluding devices 100, 100' include biodegradable metals or metal alloys such as alloys where the primary component (by weight, the largest amount) is selected from the group consisting of magnesium, iron, zinc, or tungsten. Other plastically deformable and biodegradable / bioerodible materials include biodegradable polymers such as, but not limited to, poly-L-lactic acid (PLLA), polylactic acid (PLA), polyglycolic acid (PGA), polyglycolide-co-L-lactide acid (PGLA), polydioxanone (PDO), polyglycolide-co-caprolactone (PGCL), and similar materials.

[0050] Figure 4 and 5 The distal portion of a balloon catheter 150 for delivering and deploying the occluding device 100 or the occluding device 100' is shown. In Figure 4 and 5 the illustrated embodiment, the occluding device 100' is shown mounted on the balloon catheter 150, but this is not restrictive, and the occluding device 100 or the occluding devices described below can be delivered and deployed using the balloon catheter 150.

[0051] The balloon catheter 150 includes an outer shaft 152, an inner shaft 154 disposed within the outer shaft 152, and a balloon 160 attached to the outer shaft 152 and the inner shaft 154, as described below. The inner shaft 154 defines a guidewire lumen 156 that extends to the distal end of the inner shaft 154. The guidewire lumen 156 may extend to the proximal end of the inner shaft 154 (not shown), or may terminate distally of the proximal end of the inner shaft 154 in a rapid-exchange configuration known to those skilled in the art. The distal tip 157 is coupled to the distal portion of the inner shaft 154. The tip lumen 159 of the distal tip 157 is in communication with the guidewire lumen 156 such that a guidewire can extend through the guidewire lumen 156 and the tip lumen 159 to enable guiding of the catheter 150 over the guidewire. An annular inflation lumen 158 is defined between the inner surface of the outer shaft 152 and the outer surface of the inner shaft 154. In other embodiments, instead of an annular inflation lumen, a separate shaft having an inflation lumen may be disposed adjacent to the inner shaft 154, or a dual-lumen shaft may be used as the inner shaft. The proximal portion of the catheter 150 (not shown) may include features such as a handle or luer fitting, an inflation source fluidly coupled to the inflation lumen 158, and other features known to those skilled in the art.

[0052] The balloon 160 includes a proximal neck 162 and a distal neck 164. The proximal neck 162 of the balloon 160 is attached to the distal portion of the outer shaft 152 at a junction 166. The distal neck 164 of the balloon 160 is attached to the distal portion of the inner shaft 154 at a junction 168. For example, the junctions 166, 168 may be an adhesive or other mechanical junction. As is known to those skilled in the art, the open distal end 153 of the outer shaft 152 extends into the interior of the balloon 160 such that inflation fluid from the inflation lumen 158 flows into the interior of the balloon 160 to inflate the balloon 160.

[0053] Figure 5 The catheter 150 is shown with the balloon 160 inflated to radially expand the occluding device 100' to a radially expanded configuration. The radial expansion of the occluding device 100' plastically deforms the occluding device 100' such that after the balloon 160 deflates, the occluding device 100' remains in the radially expanded configuration. As Figure 5As shown, the first portion 110 of the occlusion device 100' is expanded to a larger cross-sectional profile or diameter compared to the second portion 120. This can be achieved by, for example but not limited to, a balloon 160 that includes a first portion 161 that is configured to radially expand to a larger diameter compared to a second portion 163 of the balloon 160. In another embodiment, instead of a single balloon 160, two balloons can be provided adjacent to each other, where the first portion 110 of the occlusion device 100' is disposed over the first balloon and the second portion 120 of the occlusion device is disposed over the second balloon. The first balloon and the second balloon are configured to radially expand to different diameters such that the first portion 110 and the second portion 120 of the occlusion device 100' radially expand to different diameters. In such embodiments, the catheter can include separate inflation lumens for each of the balloons in the balloon, or an inflation lumen that extends to both balloons and has lateral openings that enter each of the balloons. In another embodiment, the occlusion device 100' is designed such that the first portion 110 radially expands to a first diameter D1, while the second portion 120 radially expands to a second diameter D2 using a balloon with uniform expansion. For example but not by way of limitation, the struts 114 and / or bends 116 of the second portion 120 can be thicker than the struts 114 and / or bends 116 of the first portion 110 such that the second portion 120 resists radial expansion to a greater extent compared to the first portion 110. Other ways of making the second portion more resistant to radial expansion can also be utilized. Except as follows, the above description of the balloon catheter 150 and the balloon 160 applies to the balloon catheter 150 used with the occlusion device 100: the balloon 160 (or balloons) can include a third portion that is configured to expand a third portion 130 of the occlusion device 100 to a third diameter D3, or the third portion 130 of the occlusion device 100 will be configured to expand to a third diameter D3 using a uniform balloon.

[0054] With the description of the occlusion devices 100, 100' and the exemplary balloon catheter 150, a method for delivering and deploying the occlusion device 100' to the left atrial appendage LAA will now be described. Return reference Figure 1, in one embodiment, a guide wire (not shown) is advanced after being introduced into the vasculature through a percutaneous access site, e.g., using the Seldinger technique, and traverses the vasculature into the left atrium LA of the heart HE. Intravascular access to the right atrium RA can be achieved through a percutaneous access site in the femoral vein up to the inferior vena cava or other known access routes. Thereafter, the guide wire advances through the circulatory system and ultimately reaches the heart HE. The guide wire is directed into the right atrium RA, crosses the right atrium, and crosses the interatrial septum with the aid of a transseptal needle or a pre-existing opening, thereby entering the left atrium LA. Once the guide wire is positioned, the luminal access port and the interatrial septum are enlarged to allow the guiding catheter to enter the left atrium LA. Thereafter, the balloon catheter 150 advances over the guide wire and through the delivery shaft of the guiding catheter, crosses the punctured interatrial septum into the left atrium LA, and is positioned adjacent to the left atrial appendage LAA. Although described as a transfemoral antegrade approach for percutaneous access to the left atrium LA, the balloon catheter 150 can be positioned in the desired region of the heart HE by different methods or routes. For example, but not by way of limitation, another possible path is to enter the brachial vein through the radial vein, through the subclavian vein, through the superior vena cava into the right atrium, and then transseptally into the left atrium. Yet another possible path is to enter the aorta through the femoral artery, enter the left ventricle through the aortic valve, and then retrograde into the left atrium through the mitral valve. In another embodiment, the left ventricle LV can be accessed by a transapical approach, and the balloon catheter 150 can advance through the left ventricle LV, the mitral valve, and into the left atrium LA adjacent to the left atrial appendage LAA. Additionally, although described in conjunction with the use of a guiding catheter and a guide wire, in another embodiment herein, the delivery catheter 150 can enter the left atrium LA without the use of a guide wire and / or a guiding catheter.

[0055] Once the balloon catheter 150 is positioned adjacent to the left atrial appendage LAA, the balloon catheter 150 is advanced such that the first portion 110 of the occlusion device 100' is positioned adjacent to the opening from the left atrium LA to the left atrial appendage LAA. Then inflation fluid is injected into the inflation lumen 158 to inflate the balloon 160, thereby radially expanding the occlusion device 100' from a radially compressed configuration to a radially expanded configuration. The occlusion device 100' is inflated until its first portion 110 spans the opening from the left atrium LA to the left atrial appendage LAA, as Figure 6 shown. Then the inflation fluid can be removed from the balloon 160 such that the balloon 160 contracts. Then the balloon catheter 150 can be removed from the patient. As explained above, the second diameter D2 of the second portion 120 of the occlusion device 100 or 100' is preferably only large enough to allow the removal of the balloon catheter 150. In the case where the balloon catheter 150 is removed, the occlusion device 100 or 100' remains in the left atrial appendage LAA, thereby preventing clots from escaping from the left atrial appendage LAA.

[0056] As described above, the occluding device 100 or 100' is made of a biodegradable or bioerodible material such that the occluding device 100 / 100' degrades / erodes within a certain period of time after being implanted into the left atrial appendage LAA. During the time required for the occluding device 100 / 100' to degrade / erode, endothelialization occurs such that tissue grows within and around the occluding device 100 / 100' such that when the occluding device 100 / 100' is completely degraded / eroded, the tissue seals the opening from the left atrial appendage LAA to the left atrium to prevent clots from escaping from the left atrial appendage LAA. The occluding device 100 / 100' may include other features that facilitate endothelialization (or for other purposes), such as but not limited to covers, graft materials, coatings, drugs, and other features known to those skilled in the art.

[0057] Figures 25 - 28 Similar embodiments of occluding devices 500, 500' for occluding the left atrial appendage are shown, which are also similar to Figure 2 and 3 the embodiments of. Referring to Figures 25 - 26 , the occluding device 500 includes a first portion 510, a second portion 520, and a third portion 530. In Figures 25 - 26 the embodiment of, the second portion 120 is disposed between the first portion 510 and the third portion 530 and connects the first portion 510 to the third portion 530. The first portion 510 and the third portion 530 are formed by a plurality of longitudinal strips or fingers 512, 532 disposed about the longitudinal axis LA of the occluding device 500. The second portion 520 may be a tube. The fingers 512 of the first portion 510 may be connected to the second portion 520 by tabs 514 that are narrower than the fingers 512. In other embodiments, the fingers 512 may be directly attached to the second portion 520 such that no tabs 514 are required. Similarly, the fingers 532 of the third portion 530 may be connected to the second portion 520 by tabs 534 that are narrower than the fingers 532. In other embodiments, the fingers 532 may be directly attached to the second portion 520 such that no tabs 534 are required. Figure 25 An occluding device 500 is shown in a radially compressed configuration such that the first portion 510, the second portion 520, and the third portion 530 have substantially the same diameter.

[0058] In an embodiment, the occluding device 500 may be delivered to the left atrial appendage LAA on a balloon catheter such as the balloon catheter 150 described above. When the balloon catheter 150 is in the desired position, the balloon 160 is inflated to radially expand the occluding device 500 from the Figure 25 radially compressed configuration shown in to the Figure 26 radially expanded configuration shown in. In such embodiments, the balloon 160 will have a similar shape to Figure 5The third part of the first part 161 of the balloon 160 shown. When the balloon is inflated, the fingers 512 of the first section 510 and the fingers 532 of the third section 530 bend at their respective connections to the second section 520 such that each finger 512, 532 moves outwardly away from the longitudinal axis LA and rotates towards the second section 520, as Figure 26 shown. Such an expanded configuration deployed in the left atrial appendage LAA prevents clots from escaping from the left atrial appendage LAA. The occlusion device 500 may include other features that facilitate endothelialization (or for other purposes), such as but not limited to coverings, graft materials, coatings, drugs, and other features known to those skilled in the art.

[0059] Figures 26 - 27 The occlusion device 500' shown is similar to the occlusion device 500, except that the occlusion device 500' only includes the first part 510 and the second part 520. All other aspects of the occlusion device 500' are the same as those of the occlusion device 500 and are therefore not repeated herein.

[0060] In each of the occlusion devices 500, 500', it is desirable to make the second diameter D2 as small as possible. As described in more detail above, when using a balloon catheter to deliver and deploy the occlusion device 500 or the occlusion device 500', the second diameter D2 only needs to be large enough so that the balloon catheter can be withdrawn from the radially expanded occlusion device 500 or 500' after the balloon of the balloon catheter has been deflated.

[0061] The occlusion devices 500, 500' can be formed from a plastically deformable material such that the occlusion devices 500, 500' can be plastically deformed. Such devices can also be referred to as balloons or mechanically expandable. Additionally, the occlusion devices 500, 500' are biodegradable or bioerodible such that the occlusion device degrades / erodes over time after being deployed within the left atrial appendage LAA of the human heart HE. For example, but not by way of limitation, plastically deformable and biodegradable / bioerodible materials suitable for the occlusion devices 500, 500' include biodegradable metals or metal alloys such as alloys having as the main component (by weight, the largest amount) selected from the group consisting of magnesium, iron, zinc, or tungsten. Other plastically deformable and biodegradable / bioerodible materials include biodegradable polymers such as but not limited to poly-L-lactic acid (PLLA), polylactic acid (PLA), polyglycolic acid (PGA), polyglycolide-co-L-lactide acid (PGLA), polydioxanone (PDO), polyglycolide-co-caprolactone (PGCL), and similar materials.

[0062] Figures 7 - 10Another embodiment of an occlusion device 200 according to an embodiment of the present disclosure is schematically illustrated. The occlusion device 200 includes a plastically deformable braided mesh 202 having a first end 203 coupled to a first collar 204 and a second end 205 coupled to a second collar 206, as Figure 7 shown. Figures 7 - 9 An occlusion device 200 for delivery and deployment into the left atrial appendage coupled to a catheter 250 is shown. As used herein, the term "braided mesh" refers to one or more wires 207 that overlap to form a mesh device that includes the wires 207 and small openings 208 disposed between the overlapping portions of the wires 207. In the illustrated embodiment, it is desirable for the openings 208 to be relatively small to prevent clots from escaping from the left atrial appendage LAA, and there is no requirement for allowing or restricting fluid flow into or out of the left atrial appendage LAA.

[0063] The wires 207 of the occlusion device 200 can be formed of a plastically deformable material such that the occlusion device 200 is plastically deformable. Such devices can also be referred to as balloon or mechanically expandable. Additionally, the wires 207 of the occlusion device 200 can be biodegradable or bioerodible such that the occlusion device 200 degrades / erodes over time after being deployed within the left atrial appendage LAA of the human heart HE. For example, but not by way of limitation, suitable plastically deformable and biodegradable / bioerodible materials for the occlusion device 200 include biodegradable metals or metal alloys such as alloys having a major component (by weight, the largest amount) selected from the group consisting of magnesium, iron, zinc, or tungsten. Other plastically deformable and biodegradable / bioerodible materials include biodegradable polymers such as, but not limited to, poly-L-lactic acid (PLLA), polylactic acid (PLA), polyglycolic acid (PGA), polyglycolide-co-L-lactide acid (PGLA), polydioxanone (PDO), polyglycolide-co-caprolactone (PGCL), and similar materials.

[0064] Figures 7 - 9 The exemplary catheter 250 shown includes an inner shaft 252 that defines a guidewire lumen 254. The catheter 250 may also include an outer shaft 256 slidably disposed over the inner shaft 252. A distal tip 260 is coupled to the inner shaft 260 and includes a tip lumen that communicates with the guidewire lumen 254 of the inner shaft 252. In the illustrated embodiment, the first collar 204 is slidably disposed over the inner shaft 252, and the second collar 206 is fixedly attached to a distal portion of the inner shaft 252 distal to the first collar 204. In such an arrangement, the first collar 204 is slidable relative to the second collar 206.

[0065] In Figures 7 - 8In the illustrated embodiment, the outer shaft 256 is not coupled to the first collar 204. However, the outer shaft 256 is arranged such that the distal end 258 of the outer shaft 256 abuts the proximal end of the first collar 204. Thus, when the catheter 250 with the occluding device 200 has been delivered to the left atrial appendage LAA as described above, the outer shaft 256 is pushed distally, which causes the first collar 204 to slide distally over the inner shaft 252 towards the second collar 206. As is shown by comparing Figure 7 and Figure 8 shown, as the distance between the first collar 204 and the second collar 206 decreases, the braided mesh 202 expands radially, as Figure 8 shown. In other embodiments, instead of pushing the outer shaft 256 such that the first collar 204 moves towards the second collar 206, the outer shaft 256 can be held in place and the inner shaft 252 can be pulled proximally. The outer shaft 256 prevents the first collar 204 from moving proximally, and pulling the inner shaft 252 causes the inner shaft 252 and the second collar 206 attached thereto to move proximally relative to the first collar 204, thereby radially expanding the braided mesh 202. Any combination of pushing the outer shaft 256 and pulling the inner shaft 252 can be used to move the first collar 204 and the second collar 206 closer together to radially expand the braided mesh 202. In some embodiments, if there is sufficient resistance to the first collar 204 in the absence of the outer shaft 256 such that pulling the inner shaft 252 does not cause the first collar to move proximally, the outer shaft 256 can be eliminated such that pulling the inner shaft 252 causes the second collar 206 to move towards the first collar 204 to radially expand the braided mesh 202.

[0066] Because the braided mesh 202 is plastically deformable, the occluding device 200 remains in a radially expanded configuration when the outer shaft 256 is withdrawn, as Figure 9 shown. After the occluding device has been radially expanded, the proximal portion 253 of the inner shaft 252 can be detached from the distal portion 257 of the inner shaft 252 and removed from the patient's body, leaving the distal portion 257 of the inner shaft 252, the distal tip 260, and the occluding device 200 in a radially expanded configuration at the treatment site. The proximal portion 253 of the inner shaft 252 can be detached from the distal portion 257 of the inner shaft 252 in various ways known to those skilled in the art, for example, but not by way of limitation, a weakened portion 255 of the inner shaft 252 can be disposed between the proximal portion 253 and the distal portion 257. After the occluding device 200 has been radially expanded, the weakened portion 255 can be disrupted, such as by an electric charge or mechanical movement. In other embodiments, as Figure 12As shown, the distal end of the proximal portion 253 of the inner shaft 252 may have external threads 270, and the proximal end of the distal portion 257 of the inner shaft 252 may have internal threads 272. After the occlusion device 200 is radially expanded, the proximal portion 253 of the inner shaft 252 is rotated to unscrew the proximal portion 253 from the distal portion 257. The threads may be reversed such that the distal portion 257 includes external threads and the proximal portion includes internal threads. As will be apparent to those skilled in the art, other ways of connecting and disconnecting the proximal portion 253 from the distal portion 257 may be utilized.

[0067] As with the Figures 1 - 6 embodiment described, the catheter 250 coupled with the occlusion device 200 may be advanced through the septum, through the apex, or by other routes known to those skilled in the art into the left atrium LA. Once in position adjacent to the left atrial appendage LAA, the catheter 250 is positioned such that upon expansion, the widest portion of the braided mesh 202 will occlude the opening between the left atrium LA and the left atrial appendage LAA. Once the occlusion device 200 is radially expanded, the outer shaft 256 (if used) may be withdrawn, the proximal portion 253 of the inner shaft 252 may be disconnected from the distal portion 257 of the inner shaft 252, and the proximal portion 253 is withdrawn, as Figures 9 - 10 shown. This leaves the distal portion 257 of the inner shaft 252, the distal tip 260, and the occlusion device 200 in a radially expanded configuration, thereby occluding the left atrial appendage LAA, as Figure 11 shown.

[0068] Figures 7 - 11The embodiments shown have an inner shaft 252 with a guide wire lumen 254 for advancing a catheter 250 over a guide wire. However, when the occlusion device 200 is deployed in the left atrial appendage LAA, the guide wire lumen 254 leaves a small opening. In some embodiments, the inner shaft 252 can act as the guide wire such that the guide wire lumen 254 is not needed. Such embodiments do not include the opening left by the guide wire lumen 254. In other embodiments having a guide wire lumen 254, the guide wire lumen 254 can be closed after the catheter 250 has been advanced over the guide wire to the treatment site. For example, but not by way of limitation, the guide wire can be removed and then an occluder can be pushed into the guide wire lumen 254 to occlude the guide wire lumen 254 in the distal portion 257 of the inner shaft. The occluder can interact with a portion of the inner surface of the inner shaft 252 to lock the occluder in place. In other embodiments, the occluder can be released to occlude the guide wire lumen when the proximal portion of the inner shaft is disconnected from the distal portion of the inner shaft. For example, but not by way of limitation, a flap or other occluder can be attached to the inner surface of the distal portion of the inner shaft. When the proximal portion of the inner shaft is seated within the distal portion of the inner shaft, the flap is pressed against the inner surface of the distal portion. When the proximal portion of the inner shaft is removed, the flap is released to occlude the guide wire lumen. Other methods and devices for occluding the guide wire lumen after delivering the catheter to the desired location can also be utilized.

[0069] Figures 13 - 19 Another embodiment of an occlusion device 300 in accordance with embodiments disclosed herein is shown. Figures 13 - 19 The occlusion device 300 includes a plurality of longitudinal struts 302 disposed adjacent to each other in a generally cylindrical pattern, with gaps 303 between circumferentially adjacent struts 302. When in the as Figure 13In the radially compressed configuration shown, since the adjacent struts 302 are adjacent to each other circumferentially, the gap 303 is small or closed. The longitudinal struts 302 extend from the first collar 304 to the second collar 306. In the illustrated embodiment, the second collar 306 is also the distal tip of the catheter 350. The first and second ends of each of the struts are attached to the first collar 304 and the second collar 306, respectively. In some embodiments, the first and second collars 304 / 306 may be formed integrally with the struts 302. For example, but not by way of limitation, the combination of the first collar 304, the second collar 306, and the struts 302 may be a cylindrical tube, and the gap 303 may be cut into the cylindrical tube to form the struts 302. The cuts terminate distally of the proximal end of the cylindrical tube and proximally of the distal end, leaving uncut portions of the cylindrical tube as the first collar 304 and the second collar 306. The occluding device 300 is delivered to the treatment site using the catheter 350 and deployed at the treatment site. In the present embodiment, the catheter 350 includes a shaft 352 that includes a guidewire lumen 354. Additional details of the catheter 350 will be described in connection with the apparatus and method for deploying the occluding device 300.

[0070] The struts 302 of the occluding device 300 may be formed of a plastically deformable material such that the occluding device 300 is plastically deformable. Such devices may also be referred to as balloons or mechanically expandable. Additionally, the struts 302 of the occluding device 300 may be biodegradable or bioerodible such that the occluding device 300 degrades / erodes over time after being deployed within the left atrial appendage LAA of the human heart HE. For example, but not by way of limitation, suitable plastically deformable and biodegradable / bioerodible materials for the occluding device 300 include biodegradable metals or metal alloys such as alloys in which the major component (by weight, the largest amount) is selected from the group consisting of magnesium, iron, zinc, or tungsten. Other plastically deformable and biodegradable / bioerodible materials include biodegradable polymers such as, but not limited to, poly-L-lactic acid (PLLA), polylactic acid (PLA), polyglycolic acid (PGA), polyglycolide-co-L-lactide acid (PGLA), polydioxanone (PDO), polyglycolide-co-caprolactone (PGCL), and similar materials.

[0071] As Figure 14 shown, the occluding device 300 is radially expanded by moving the first collar 304 and the second collar 306 closer to each other. As Figure 1 and 2 shown, the struts may include defects or hinges 305 for preferential bending when the collars 304, 306 are moved closer to each other.

[0072] Figure 15 and 16An embodiment of a mechanism for moving a first collar 304 and a second collar 306 closer to each other to radially expand an occluding device 300 is shown. In the illustrated embodiment, a shaft 352 extends distally into the second collar / distal tip 306 / 360. The tip lumen of the second collar / distal tip 306 / 360 is aligned with the guidewire lumen 354 of the inner shaft. However, the shaft 352 is not connected to the second collar / distal tip 306 / 360 such that the shaft 352 can move relative to the second collar / distal tip 306 / 360.

[0073] As Figure 15 and 16 shown, a portion of the shaft 352 includes threads 370 on its outer surface. The first collar 304 includes mating threads 372 on its inner surface. Thus, as Figure 15 shown, the threads 370 on the outer surface of the shaft 352 mate with the threads 370 on the inner surface of the first collar 304. As described above, Figure 15 a catheter 350 attached with an occluding device 300 in a radially compressed configuration as shown is delivered to the left atrial appendage LAA. When it is desired to radially expand the occluding device 300, the shaft 352 is rotated. The shaft 352 is prevented from retracting. Thus, the first collar 304 moves distally along the threads 370 as Figure 16 shown. By moving the first collar 304 closer to the second collar 306, the struts 302 must bend and bend at the hinge 305. In one embodiment, when the first collar 304 reaches the distal end of the threads 370 of the shaft 352, the shaft 352 can be withdrawn proximally, leaving only the occluding device 300 in a radially expanded configuration as Figure 19 shown.

[0074] As explained above, it is desirable to leave only small gaps or openings in the occluding device 300 such that clots cannot escape from the left atrial appendage LAA. Also as explained above, if the shaft 352 is removed, the opening 309 in the first collar 304 through which the shaft 352 extends may be such an undesirable opening. Thus, in one embodiment, as Figures 17 - 18 shown, a flap 380 can be attached to the distal end or the proximal end of the first collar 304. In Figures 17 - 18 the illustrated embodiment, the flap 380 is attached to the distal end of the first collar 304. The flap 380 is hingedly connected to the first collar 380. Thus, when the shaft 352 is positioned through the first collar 304 (not shown in Figure 17 for clarity), the shaft 352 causes the flap 380 to extend such that the flap is generally longitudinally oriented with respect to the catheter 350. When the shaft 352 is withdrawn from the opening 307, the flap 380 folds longitudinally toward the central longitudinal axis LA of the first collar 304 as Figure 18As shown. The flap 380 closes the opening 309 or significantly reduces the size of the opening 309 to prevent clots from leaving the left atrial appendage LAA. For clarity, Figure 17 and 18 the struts 302 are omitted in Figures 17 - 18 and

[0075] Although four flaps are shown, this is not meant to be limiting, and more or fewer flaps may be utilized. The flap 380 may be made of the same material as the first collar 304 and the struts 302, or of a different material. As explained above with respect to the previous embodiments, the catheter 350 coupled with the occlusion device 300 may be advanced into the left atrium LA via the septum, via the apex, or through other routes known to those skilled in the art. Once positioned adjacent to the left atrial appendage LAA, the catheter 350 is positioned such that the widest portion of the struts 302 will occlude the opening between the left atrium LA and the left atrial appendage LAA upon expansion. Once the occlusion device 300 is radially expanded, the shaft 352 may be withdrawn, as Figure 16 and 19 shown. This leaves the distal portion of the occlusion device 300 in a radially expanded configuration, thereby occluding the left atrial appendage LAA, also as Figure 19 shown.

[0076] The threaded shaft 352 described above with respect to the Figures 7 - 11 embodiment may be used in place of the deployment mechanism described with respect to that embodiment. Additionally, the deployment mechanism described with respect to the Figures 15 - 19 embodiment may be used in conjunction with the occlusion device 300 described with respect to Figures 7 - 12 the Figures 13 - 19 embodiment.

[0077] Figures 20 - 24 Another embodiment of an occlusion device 400 according to the embodiments disclosed herein is shown. Figures 20 - 24 The occlusion device 400 of Figure 21 is a shape memory wire 402 configured to occlude the left atrial appendage LAA. The wire 402 is delivered to the left atrial appendage in a catheter 404. When disposed within the lumen 406 of the catheter 404, the wire 402 is in a straightened configuration (for clarity, the size of the lumen is enlarged in the drawing compared to the wire 402). The catheter 404 containing the wire 402 is delivered to the left atrial appendage LAA by one of the methods described above, with the wire 402 in a straightened configuration. When at the treatment site, the wire 402 is pushed out through the opening 408 at the distal end of the catheter 404. No longer constrained by the catheter, the wire 402 returns to its preset shape, as Figure 21As shown. In other embodiments, the wire 402 itself can be pushed, and then the proximal portion of the wire 402 to be removed can be separated from the distal portion of the wire 402 that has already been deployed in the left atrial appendage LAA.

[0078] Once deployed, the wire 402 fills the left atrial appendage LAA, as Figures 23 - 24 shown, thereby preventing clots from escaping from the left atrial appendage LAA. In Figures 21 - 23 the embodiment shown, the preset shape is helical. However, this is not meant to be limiting, and the wire 402 can be preset to other shapes to prevent clots from escaping from the left atrial appendage LAA. For example, but not by way of limitation, Figure 24 shown is a preset shape of a coil that can be described as being similar to an embolization coil or a cerebral aneurysm coil. Other shapes can also be used as long as the shape is sufficient to occlude the left atrial appendage LAA to prevent clots from leaving the left atrial appendage.

[0079] The wire 402 of the occlusion device 400 can be formed of a shape memory material. Additionally, the wire 402 of the occlusion device 400 is biodegradable or bioerodible, such that the occlusion device 400 degrades / erodes over time after being deployed within the left atrial appendage LAA of the human heart HE. For example, but not by way of limitation, shape memory and biodegradable / bioerodible materials suitable for use as the wire 402 of the occlusion device 400 include biodegradable metals or metal alloys such as alloys having as the main component (in terms of weight, the largest amount) selected from the group consisting of magnesium, iron, zinc, or tungsten. Other shape memory and biodegradable / bioerodible materials include biodegradable polymers such as, but not limited to, poly-L-lactic acid (PLLA), polylactic acid (PLA), polyglycolic acid (PGA), polyglycolide-co-L-lactide acid (PGLA), polydioxanone (PDO), polyglycolide-co-caprolactone (PGCL), and similar materials.

[0080] Although various embodiments in accordance with the present invention have been described above, it should be understood that the embodiments are presented by way of illustration and example only and not by way of limitation. Various changes can be made in form and detail without departing from the spirit and scope of the present invention. Accordingly, the breadth and scope of the present invention should not be limited by any of the exemplary embodiments described above, but should be defined only in accordance with the appended claims and their equivalents. It should also be understood that each feature of each embodiment discussed herein and each feature of each reference cited herein can be combined with the features of any other embodiment. All patents and published documents discussed herein are incorporated herein by reference in their entirety.

Claims

1. An assembly of an occluding device and a balloon catheter, the occluding device being for occluding the left atrial appendage, and the balloon catheter being for delivering and deploying the occluding device, wherein the occluding device comprises: a first part; and a second part, the second part being attached to the first part, the balloon catheter comprising a first balloon portion and a second balloon portion, the first balloon portion being capable of radially expanding to a larger diameter than the second balloon portion, the first part being disposed on the first balloon portion, and the second part being disposed on the second balloon portion; wherein when the first balloon portion and the second balloon portion are inflated, the occluding device is capable of plastically deforming from a radially compressed configuration to a radially expanded configuration, wherein in the radially expanded configuration, the first part has a larger cross-sectional profile than the second part.

2. The assembly according to claim 1, wherein the first part comprises a plurality of rings disposed adjacent to each other about a central longitudinal axis, each of the rings comprising a plurality of struts connected to each other by bends.

3. The assembly according to claim 2, wherein the second part comprises a plurality of rings disposed adjacent to each other about a central longitudinal axis, each of the rings comprising a plurality of struts connected to each other by bends.

4. The assembly according to claim 1, wherein the occluding device further comprises a third part, wherein the second part is disposed between the first part and the third part, wherein the balloon catheter further comprises a third balloon portion, the third part being disposed on the third balloon portion, and wherein in the radially expanded configuration, the third part has a larger cross-sectional profile than the second part.

5. The assembly according to claim 1, wherein the first part comprises a plurality of fingers disposed about the longitudinal axis of the occluding device in the radially compressed configuration.

6. The assembly according to claim 5, wherein in the radially expanded configuration, the plurality of fingers of the first part move radially outward and rotate towards the second part.

7. The assembly according to claim 5, wherein the occluding device further comprises a third part, wherein the second part is disposed between the first part and the third part, wherein the balloon catheter further comprises a third balloon portion, the third part being disposed on the third balloon portion, and wherein in the radially expanded configuration, the third part has a larger cross-sectional profile than the second part.

8. The assembly according to claim 7, wherein the third part comprises a plurality of fingers disposed about the longitudinal axis of the occluding device in the radially compressed configuration.

9. The assembly according to claim 8, wherein in the radially expanded configuration, the plurality of fingers of the third part move radially outward and rotate towards the second part.

10. The assembly according to claim 1, wherein the occluding device is biodegradable.

11. The assembly according to claim 10, wherein the occluding device is made of a metal or metal alloy capable of plastic deformation.

12. The component according to claim 1, wherein the first balloon portion and the second balloon portion comprise two balloons adjacent to each other.

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